Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad...
Transcript of Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad...
![Page 1: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/1.jpg)
901143 - ACIDO MALICO GRANULAR 20/25 MESH...
Ficha de datos de seguridadsegún 1907/2006/CE (REACH), 2015/830/EU
SECCIÓN 1: IDENTIFICACIÓN DE LA SUSTANCIA O LA MEZCLA Y DE LA SOCIEDAD O EMPRESA
1.1 Identificador del producto: 901143 - ACIDO MALICO GRANULAR 20/25 MESH...
Acido DL-malico
CAS: 617-48-1
CE: 210-514-9
Index: No aplicable
REACH: 01-2119552463-40-XXXX
1.2 Usos pertinentes identificados de la sustancia o de la mezcla y usos desaconsejados:
Usos pertinentes: Aditivo alimentario
Usos desaconsejados: Todo aquel uso no especificado en este epígrafe ni en el epígrafe 7.3
1.3 Datos del proveedor de la ficha de datos de seguridad:
Quimidroga S.A.C/ Tuset, 2608006 Barcelona - SpainTfno.: +34 932363636 - Fax: +34 [email protected]
1.4 Teléfono de emergencia: +34 932363636 (24h)
SECCIÓN 2: IDENTIFICACIÓN DE LOS PELIGROS
2.1 Clasificación de la sustancia o de la mezcla:
Reglamento nº1272/2008 (CLP):
La clasificación de este producto se ha realizado conforme el Reglamento nº1272/2008 (CLP).
Eye Irrit. 2: Irritación ocular, categoría 2, H319
2.2 Elementos de la etiqueta:
Reglamento nº1272/2008 (CLP):
Atención
Indicaciones de peligro:
Eye Irrit. 2: H319 - Provoca irritación ocular grave
Consejos de prudencia:
P264: Lavarse concienzudamente tras la manipulaciónP280: Llevar guantes/prendas/gafas/máscara de protecciónP305+P351+P338: EN CASO DE CONTACTO CON LOS OJOS: Enjuagar con agua cuidadosamente durante varios minutos. Quitarlas lentes de contacto cuando estén presentes y pueda hacerse con facilidad. Proseguir con el lavadoP337+P313: Si persiste la irritación ocular: Consultar a un médico
2.3 Otros peligros:
El producto no cumple los criterios PBT/vPvB
SECCIÓN 3: COMPOSICIÓN/INFORMACIÓN SOBRE LOS COMPONENTES
3.1 Sustancia:
Descripción química: Ácidos carboxílicos
Componentes:
De acuerdo al Anexo II del Reglamento (CE) nº1907/2006 (punto 3), el producto presenta:
Emisión: 04/09/2019 Versión: 1
- CONTINÚA EN LA SIGUIENTE PÁGINA -
Documento generado con CHEMETER (www.siam-it.com)1/243
![Page 2: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/2.jpg)
901143 - ACIDO MALICO GRANULAR 20/25 MESH...
Ficha de datos de seguridadsegún 1907/2006/CE (REACH), 2015/830/EU
SECCIÓN 3: COMPOSICIÓN/INFORMACIÓN SOBRE LOS COMPONENTES (continúa)
Identificación Nombre químico/clasificación Concentración
AutoclasificadaAcido DL-malico
Reglamento 1272/2008 Eye Irrit. 2: H319 - Atención100 %
Para ampliar información sobre la peligrosidad de la sustancias consultar las secciones 8, 11, 12, 15 y 16.
3.2 Mezclas:
No aplicable
SECCIÓN 4: PRIMEROS AUXILIOS
4.1 Descripción de los primeros auxilios:
Los síntomas como consecuencia de una intoxicación pueden presentarse con posterioridad a la exposición, por lo que, en casode duda, exposición directa al producto químico o persistencia del malestar solicitar atención médica, mostrándole la FDS de esteproducto.
Por inhalación:
Se trata de un producto que no contiene sustancias clasificadas como peligrosas por inhalación, sin embargo, en caso desíntomas de intoxicación sacar al afectado de la zona de exposición y proporcionarle aire fresco. Solicitar atención médica si lossíntomas se agravan o persisten.
Por contacto con la piel:
En caso de contacto se recomienda limpiar la zona afecta con agua por arrastre y con jabón neutro. En caso de alteraciones enla piel (escozor, rojez, sarpullidos, ampollas…), acudir a consulta médica con esta Ficha de Datos de Seguridad
Por contacto con los ojos:
Enjuagar los ojos con abundante agua a temperatura ambiente al menos durante 15 minutos. Evitar que el afectado se frote ocierre los ojos. En el caso de que el accidentado use lentes de contacto, éstas deben retirarse siempre que no estén pegadas alos ojos, de otro modo podría producirse un daño adicional. En todos los casos, después del lavado, se debe acudir al médico lomás rápidamente posible con la FDS del producto.
Por ingestión/aspiración:
En caso de ingestión, solicitar asistencia médica inmediata mostrando la FDS de este producto.
4.2 Principales síntomas y efectos, agudos y retardados:
Los efectos agudos y retardados son los indicados en las secciones 2 y 11.
4.3 Indicación de toda atención médica y de los tratamientos especiales que deban dispensarse inmediatamente:
No relevante
SECCIÓN 5: MEDIDAS DE LUCHAS CONTRA INCENDIOS
5.1 Medios de extinción:
Producto no inflamable bajo condiciones normales de almacenamiento, manipulación y uso. En caso de inflamación comoconsecuencia de manipulación, almacenamiento o uso indebido emplear preferentemente extintores de polvo polivalente (polvoABC), de acuerdo al Reglamento de instalaciones de protección contra incendios (R.D. 513/2017 y posteriores modificaciones).NO SE RECOMIENDA emplear agua a chorro como agente de extinción.
5.2 Peligros específicos derivados de la sustancia o la mezcla:
Como consecuencia de la combustión o descomposición térmica se generan subproductos de reacción que pueden resultaraltamente tóxicos y, consecuentemente, pueden presentar un riesgo elevado para la salud.
5.3 Recomendaciones para el personal de lucha contra incendios:
En función de la magnitud del incendio puede hacerse necesario el uso de ropa protectora completa y equipo de respiraciónautónomo. Disponer de un mínimo de instalaciones de emergencia o elementos de actuación (mantas ignífugas, botiquínportátil,...) conforme al R.D.486/1997 y posteriores modificaciones
Disposiciones adicionales:
Actuar conforme el Plan de Emergencia Interior y las Fichas Informativas sobre actuación ante accidentes y otras emergencias.Suprimir cualquier fuente de ignición. En caso de incendio, refrigerar los recipientes y tanques de almacenamiento de productossusceptibles a inflamación, explosión o BLEVE como consecuencia de elevadas temperaturas. Evitar el vertido de los productosempleados en la extinción del incendio al medio acuático.
Emisión: 04/09/2019 Versión: 1
- CONTINÚA EN LA SIGUIENTE PÁGINA -
Documento generado con CHEMETER (www.siam-it.com)
CAS:CE:Index:REACH:
617-48-1210-514-9No aplicable01-2119552463-40-XXXX
2/243
![Page 3: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/3.jpg)
901143 - ACIDO MALICO GRANULAR 20/25 MESH...
Ficha de datos de seguridadsegún 1907/2006/CE (REACH), 2015/830/EU
SECCIÓN 6: MEDIDAS EN CASO DE VERTIDO ACCIDENTAL
6.1 Precauciones personales, equipo de protección y procedimientos de emergencia:
Barrer y recoger el producto con palas u otros medios e introducirlo en un recipiente para su reutilización (preferentemente) o sueliminación.
6.2 Precauciones relativas al medio ambiente:
Producto no clasificado como peligroso para el medioambiente. Mantener el producto alejado de los desagües y de las aguassuperficiales y subterráneas.
6.3 Métodos y material de contención y de limpieza:
Se recomienda:
Barrer y recoger el producto con palas u otros medios e introducirlo en un recipiente para su reutilización (preferentemente) o sueliminación.
6.4 Referencias a otras secciones:
Ver secciones 8 y 13.
SECCIÓN 7: MANIPULACIÓN Y ALMACENAMIENTO
7.1 Precauciones para una manipulación segura:
A.- Precauciones generales
Cumplir con la legislación vigente en materia de prevención de riesgos laborales. Mantener los recipientes herméticamentecerrados. Controlar los derrames y residuos, eliminándolos con métodos seguros (sección 6). Evitar el vertido libre desde elrecipiente. Mantener orden y limpieza donde se manipulen productos peligrosos.
B.- Recomendaciones técnicas para la prevención de incendios y explosiones.
Debido a sus características de inflamabilidad, el producto no presenta riesgo de incendio bajo condiciones normales dealmacenamiento, manipulación y uso.
C.- Recomendaciones técnicas para prevenir riesgos ergonómicos y toxicológicos.
Para control de exposición consultar la sección 8. No comer, beber ni fumar en las zonas de trabajo; lavarse las manosdespués de cada utilización, y despojarse de prendas de vestir y equipos de protección contaminados antes de entrar en laszonas para comer.
D.- Recomendaciones técnicas para prevenir riesgos medioambientales
Se recomienda disponer de material absorbente en las proximidades del producto (ver epígrafe 6.3)
7.2 Condiciones de almacenamiento seguro, incluidas posibles incompatibilidades:
A.- Medidas técnicas de almacenamiento
ITC (R.D.656/2017): No relevante
Clasificación: No relevante
B.- Condiciones generales de almacenamiento.
Evitar fuentes de calor, radiación, electricidad estática y el contacto con alimentos. Para información adicional ver epígrafe10.5
7.3 Usos específicos finales:
Salvo las indicaciones ya especificadas no es preciso realizar ninguna recomendación especial en cuanto a los usos de esteproducto.
SECCIÓN 8: CONTROLES DE EXPOSICIÓN/PROTECCIÓN INDIVIDUAL
8.1 Parámetros de control:
Sustancias cuyos valores límite de exposición profesional han de controlarse en el ambiente de trabajo (INSST 2019)
Partículas no especificadas de otra forma: Fracción inhalable VLA-ED= 10 mg/m3 // Fracción respirable VLA-ED= 3 mg/m3
DNEL (Trabajadores):
Emisión: 04/09/2019 Versión: 1
- CONTINÚA EN LA SIGUIENTE PÁGINA -
Documento generado con CHEMETER (www.siam-it.com)3/243
![Page 4: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/4.jpg)
901143 - ACIDO MALICO GRANULAR 20/25 MESH...
Ficha de datos de seguridadsegún 1907/2006/CE (REACH), 2015/830/EU
SECCIÓN 8: CONTROLES DE EXPOSICIÓN/PROTECCIÓN INDIVIDUAL (continúa)
Corta exposición Larga exposición
Identificación Sistémica Local Sistémica Local
Acido DL-malico Oral No relevante No relevante No relevante No relevante
CAS: 617-48-1 Cutánea 40 mg/kg No relevante 2 mg/kg No relevante
CE: 210-514-9 Inhalación 104 mg/m³ 104 mg/m³ 5,33 mg/m³ 32 mg/m³
DNEL (Población):
Corta exposición Larga exposición
Identificación Sistémica Local Sistémica Local
Acido DL-malico Oral 20 mg/kg No relevante 6 mg/kg No relevante
CAS: 617-48-1 Cutánea 20 mg/kg No relevante 6 mg/kg No relevante
CE: 210-514-9 Inhalación 52 mg/m³ 52 mg/m³ 1,6 mg/m³ 1,6 mg/m³
PNEC:
Identificación
Acido DL-malico STP 3 mg/L Agua dulce 0,1 mg/L
CAS: 617-48-1 Suelo No relevante Agua salada 0,01 mg/L
CE: 210-514-9 Intermitente 1 mg/L Sedimento (Agua dulce) No relevante
Oral No relevante Sedimento (Agua salada) No relevante
8.2 Controles de la exposición:
A.- Medidas generales de seguridad e higiene en el ambiente de trabajo:
Como medida de prevención se recomienda la utilización de equipos de protección individual básicos, con el correspondientemarcado CE de acuerdo al R.D.1407/1992 y posteriores modificaciones. Para más información sobre los equipos deprotección individual (almacenamiento, uso, limpieza, mantenimiento, clase de protección,…) consultar el folleto informativofacilitado por el fabricante del EPI. Las indicaciones contenidas en este punto se refieren al producto puro. Las medidas deprotección para el producto diluido podrán variar en función de su grado de dilución, uso, método de aplicación, etc. Paradeterminar la obligación de instalación de duchas de emergencia y/o lavaojos en los almacenes se tendrá en cuenta lanormativa referente al almacenamiento de productos químicos aplicable en cada caso. Para más información ver epígrafes 7.1y 7.2.Toda la información aquí incluida es una recomendación siendo necesario su concreción por parte de los servicios deprevención de riesgos laborales al desconocer las medidas de prevención adicionales que la empresa pudiese disponer o sihan sido incluidos en la evaluación de riesgos pertinentes.
B.- Protección respiratoria.
Pictograma EPI Marcado Normas CEN Observaciones
Uso obligatorio demascarilla
Mascarilla autofiltrante parapartículas
EN 149:2001+A1:2009Reemplazar cuando se note un aumento de la
resistencia a la respiración.
C.- Protección específica de las manos.
Pictograma EPI Marcado Normas CEN Observaciones
Proteccion obligatoriade la manos
Guantes de protección contrariesgos menores
Reemplazar los guantes ante cualquier indicio dedeterioro. Para periodos de exposición prolongadosal producto para usuarios profesionales/industrialesse hace recomendable la utilización de guantes CE
III, de acuerdo a las normas EN 420 y EN 374
D.- Protección ocular y facial
Pictograma EPI Marcado Normas CEN Observaciones
Proteccion obligatoriade la cara
Gafas panorámicas contrasalpicaduras y/o
proyecciones
EN 166:2001EN ISO 4007:2018
Limpiar a diario y desinfectar periódicamente deacuerdo a las instrucciones del fabricante. Se
recomienda su uso en caso de riesgo desalpicaduras.
E.- Protección corporal
Emisión: 04/09/2019 Versión: 1
- CONTINÚA EN LA SIGUIENTE PÁGINA -
Documento generado con CHEMETER (www.siam-it.com)4/243
![Page 5: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/5.jpg)
901143 - ACIDO MALICO GRANULAR 20/25 MESH...
Ficha de datos de seguridadsegún 1907/2006/CE (REACH), 2015/830/EU
SECCIÓN 8: CONTROLES DE EXPOSICIÓN/PROTECCIÓN INDIVIDUAL (continúa)
Pictograma EPI Marcado Normas CEN Observaciones
Ropa de trabajo
Reemplazar ante cualquier indicio de deterioro.Para periodos de exposición prolongados al
producto para usuarios profesionalesindustriales sehace recomendable CE III, de acuerdo a las normas
EN ISO 6529:2013, EN ISO 6530:2005, EN ISO13688:2013, EN 464:1994
Calzado de trabajoantideslizamiento
EN ISO 20347:2012
Reemplazar ante cualquier indicio de deterioro.Para periodos de exposición prolongados al
producto para usuarios profesionalesindustriales sehace recomendable CE III, de acuerdo a las normas
EN ISO 20345:2012 y EN 13832-1:2007
F.- Medidas complementarias de emergencia
Medida de emergencia Normas Medida de emergencia Normas
Ducha de emergencia
ANSI Z358-1ISO 3864-1:2011, ISO 3864-4:2011
Lavaojos
DIN 12 899ISO 3864-1:2011, ISO 3864-4:2011
Controles de la exposición del medio ambiente:
En virtud de la legislación comunitaria de protección del medio ambiente se recomienda evitar el vertido tanto del producto comode su envase al medio ambiente. Para información adicional ver epígrafe 7.1.D
Compuestos orgánicos volátiles:
En aplicación al R.D.117/2003 y posteriores modificaciones (Directiva 2010/75/EU), este producto presenta las siguientescaracterísticas:
C.O.V. (Suministro): 0 % peso
Concentración C.O.V. a 20 ºC: 0 kg/m³ (0 g/L)
Número de carbonos medio: No relevante
Peso molecular medio: No relevante
SECCIÓN 9: PROPIEDADES FÍSICAS Y QUÍMICAS
9.1 Información de propiedades físicas y químicas básicas:
Para completar la información ver la ficha técnica/hoja de especificaciones del producto.
Aspecto físico:
Estado físico a 20 ºC: Sólido
Aspecto: Granulado
Color: Blanco
Olor: Inodoro
Umbral olfativo: No relevante *
Volatilidad:
Temperatura de ebullición a presión atmosférica: No relevante *
Presión de vapor a 20 ºC: No relevante *
Presión de vapor a 50 ºC: No relevante *
Tasa de evaporación a 20 ºC: No relevante *
Caracterización del producto:
Densidad a 20 ºC: No relevante *
Densidad relativa a 20 ºC: No relevante *
Viscosidad dinámica a 20 ºC: No relevante *
Viscosidad cinemática a 20 ºC: No relevante *
Viscosidad cinemática a 40 ºC: No relevante *
*No relevante debido a la naturaleza del producto, no aportando información característica de su peligrosidad.
Emisión: 04/09/2019 Versión: 1
- CONTINÚA EN LA SIGUIENTE PÁGINA -
Documento generado con CHEMETER (www.siam-it.com)5/243
![Page 6: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/6.jpg)
901143 - ACIDO MALICO GRANULAR 20/25 MESH...
Ficha de datos de seguridadsegún 1907/2006/CE (REACH), 2015/830/EU
SECCIÓN 9: PROPIEDADES FÍSICAS Y QUÍMICAS (continúa)
Concentración: No relevante *
pH: No relevante *
Densidad de vapor a 20 ºC: No relevante *
Coeficiente de reparto n-octanol/agua a 20 ºC: -1,26
Solubilidad en agua a 20 ºC: 558 kg/m³
Propiedad de solubilidad: No relevante *
Temperatura de descomposición: No relevante *
Punto de fusión/punto de congelación: 127 - 132 ºC
Propiedades explosivas: No relevante *
Propiedades comburentes: No relevante *
Inflamabilidad:
Punto de inflamación: 203 ºC
Inflamabilidad (sólido, gas): No relevante *
Temperatura de auto-inflamación: 349 ºC
Límite de inflamabilidad inferior: No relevante *
Límite de inflamabilidad superior: No relevante *
Explosividad:
Límite inferior de explosividad: No relevante *
Límite superior de explosividad: No relevante *
9.2 Otros datos:
Tensión superficial a 20 ºC: No relevante *
Índice de refracción: No relevante *
*No relevante debido a la naturaleza del producto, no aportando información característica de su peligrosidad.
SECCIÓN 10: ESTABILIDAD Y REACTIVIDAD
10.1 Reactividad:
No se esperan reacciones peligrosas si se cumplen las instrucciones técnicas de almacenamiento de productos químicos. Versección 7.
10.2 Estabilidad química:
Estable químicamente bajo las condiciones indicadas de almacenamiento, manipulación y uso.
10.3 Posibilidad de reacciones peligrosas:
Bajo las condiciones indicadas no se esperan reacciones peligrosas que puedan producir una presión o temperaturas excesivas.
10.4 Condiciones que deben evitarse:
Aplicables para manipulación y almacenamiento a temperatura ambiente:
Choque y fricción Contacto con el aire Calentamiento Luz Solar Humedad
No aplicable No aplicable No aplicable No aplicable No aplicable
10.5 Materiales incompatibles:
Ácidos Agua Materias comburentes Materias combustibles Otros
Evitar ácidos fuertes No aplicable No aplicable No aplicable Evitar alcalis o bases fuertes
10.6 Productos de descomposición peligrosos:
Ver epígrafe 10.3, 10.4 y 10.5 para conocer los productos de descomposición específicamente. En dependencia de las condicionesde descomposición, como consecuencia de la misma pueden liberarse mezclas complejas de sustancias químicas: dióxido decarbono (CO2), monóxido de carbono y otros compuestos orgánicos.
SECCIÓN 11: INFORMACIÓN TOXICOLÓGICA
Emisión: 04/09/2019 Versión: 1
- CONTINÚA EN LA SIGUIENTE PÁGINA -
Documento generado con CHEMETER (www.siam-it.com)6/243
![Page 7: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/7.jpg)
901143 - ACIDO MALICO GRANULAR 20/25 MESH...
Ficha de datos de seguridadsegún 1907/2006/CE (REACH), 2015/830/EU
SECCIÓN 11: INFORMACIÓN TOXICOLÓGICA (continúa)
11.1 Información sobre los efectos toxicológicos:
No se dispone de datos experimentales del producto en si mismos relativos a las propiedades toxicológicas
Efectos peligrosos para la salud:
En caso de exposición repetitiva, prolongada o a concentraciones superiores a las establecidas por los límites de exposiciónprofesionales, pueden producirse efectos adversos para la salud en función de la vía de exposición:
A- Ingestión (efecto agudo):
- Toxicidad aguda: A la vista de los datos disponibles, no se cumplen los criterios de clasificación, no presentando sustanciasclasificadas como peligrosas por ingestión. Para más información ver sección 3.- Corrosividad/Irritabilidad: A la vista de los datos disponibles, no se cumplen los criterios de clasificación, no presentandosustancias clasificadas como peligrosas por este efecto. Para más información ver sección 3.
B- Inhalación (efecto agudo):
- Toxicidad aguda: A la vista de los datos disponibles, no se cumplen los criterios de clasificación, no presentando sustanciasclasificadas como peligrosas por inhalación. Para más información ver sección 3.- Corrosividad/Irritabilidad: A la vista de los datos disponibles, no se cumplen los criterios de clasificación, no presentandosustancias clasificadas como peligrosas por este efecto. Para más información ver sección 3.
C- Contacto con la piel y los ojos (efecto agudo):
- Contacto con la piel: A la vista de los datos disponibles, no se cumplen los criterios de clasificación, no presentandosustancias clasificadas como peligrosas por contacto con la piel. Para más información ver sección 3.- Contacto con los ojos: Produce lesiones oculares tras contacto.
D- Efectos CMR (carcinogenicidad, mutagenicidad y toxicidad para la reproducción):
- Carcinogenicidad: A la vista de los datos disponibles, no se cumplen los criterios de clasificación, no presentando sustanciasclasificadas como peligrosas por los efectos descritos. Para más información ver sección 3. IARC: No relevante- Mutagenicidad: A la vista de los datos disponibles, no se cumplen los criterios de clasificación, no presentando sustanciasclasificadas como peligrosas por este efecto. Para más información ver sección 3.- Toxicidad para la reproducción: A la vista de los datos disponibles, no se cumplen los criterios de clasificación, nopresentando sustancias clasificadas como peligrosas por este efecto. Para más información ver sección 3.
E- Efectos de sensibilización:
- Respiratoria: A la vista de los datos disponibles, no se cumplen los criterios de clasificación, no presentando sustanciasclasificadas como peligrosas con efectos sensibilizantes por encima de los límites recogidos en el punto 3.2 del Reglamento(CE) 2015/830. Para más información ver secciónes 2, 3 y 15.- Cutánea: A la vista de los datos disponibles, no se cumplen los criterios de clasificación, no presentando sustanciasclasificadas como peligrosas por este efecto. Para más información ver sección 3.
F- Toxicidad específica en determinados órganos (STOT)-exposición única:
A la vista de los datos disponibles, no se cumplen los criterios de clasificación, no presentando sustancias clasificadas comopeligrosas por este efecto. Para más información ver sección 3.
G- Toxicidad específica en determinados órganos (STOT)-exposición repetida:
- Toxicidad específica en determinados órganos (STOT)-exposición repetida: A la vista de los datos disponibles, no secumplen los criterios de clasificación, no presentando sustancias clasificadas como peligrosas por este efecto. Para másinformación ver sección 3.- Piel: A la vista de los datos disponibles, no se cumplen los criterios de clasificación, no presentando sustancias clasificadascomo peligrosas por este efecto. Para más información ver sección 3.
H- Peligro por aspiración:
A la vista de los datos disponibles, no se cumplen los criterios de clasificación, no presentando sustancias clasificadas comopeligrosas por este efecto. Para más información ver sección 3.
Información adicional:
No relevante
Información toxicológica específica de las sustancias:
Identificación Toxicidad aguda Género
Acido DL-malico DL50 oral 10700 mg/kg Rata
CAS: 617-48-1 DL50 cutánea No relevante
CE: 210-514-9 CL50 inhalación No relevante
Emisión: 04/09/2019 Versión: 1
- CONTINÚA EN LA SIGUIENTE PÁGINA -
Documento generado con CHEMETER (www.siam-it.com)7/243
![Page 8: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/8.jpg)
901143 - ACIDO MALICO GRANULAR 20/25 MESH...
Ficha de datos de seguridadsegún 1907/2006/CE (REACH), 2015/830/EU
SECCIÓN 12: INFORMACIÓN ECOLÓGICA
12.1 Toxicidad:
No determinado
12.2 Persistencia y degradabilidad:
No disponible
12.3 Potencial de bioacumulación:
No determinado
12.4 Movilidad en el suelo:
No determinado
12.5 Resultados de la valoración PBT y mPmB:
El producto no cumple los criterios PBT/vPvB
12.6 Otros efectos adversos:
No descritos
SECCIÓN 13: CONSIDERACIONES RELATIVAS A LA ELIMINACIÓN
13.1 Métodos para el tratamiento de residuos:
Código DescripciónTipo de residuo (Reglamento (UE) nº
1357/2014)
20 01 14* Ácidos Peligroso
Tipo de residuo (Reglamento (UE) nº 1357/2014):
HP4 Irritante — irritación cutánea y lesiones oculares
Gestión del residuo (eliminación y valorización):
Consultar al gestor de residuos autorizado las operaciones de valorización y eliminación conforme al Anexo 1 y Anexo 2 (Directiva2008/98/CE, Ley 22/2011). De acuerdo a los códigos 15 01 (2014/955/UE) en el caso de que el envase haya estado en contactodirecto con el producto se gestionará del mismo modo que el propio producto, en caso contrario se gestionará como residuo nopeligroso. Se desaconseja su vertido a cursos de agua. Ver epígrafe 6.2.
Disposiciones legislativas relacionadas con la gestión de residuos:
De acuerdo al Anexo II del Reglamento (CE) nº1907/2006 (REACH) se recogen las disposiciones comunitarias o estatalesrelacionadas con la gestión de residuos.
Legislación comunitaria: Directiva 2008/98/CE, 2014/955/UE, Reglamento (UE) nº 1357/2014Legislación nacional: Ley 22/2011, Real Decreto 180/2015, Ley 11/1997
SECCIÓN 14: INFORMACIÓN RELATIVA AL TRANSPORTE
Este producto no está regulado para su transporte (ADR/RID,IMDG,IATA)
SECCIÓN 15: INFORMACIÓN REGLAMENTARIA
Sustancias candidatas a autorización en el Reglamento (CE) 1907/2006 (REACH): No relevante
Sustancias incluidas en el Anexo XIV de REACH (lista de autorización) y fecha de expiración: No relevante
Reglamento (CE) 1005/2009, sobre sustancias que agotan la capa de ozono: No relevante
Sustancias activas las cuales han sido incluidas en el Artículo 95 del Reglamento (UE) Nº 528/2012: No relevante
REGLAMENTO (UE) No 649/2012, relativo a la exportación e importación de productos químicos peligrosos: No relevante
15.1 Reglamentación y legislación en materia de seguridad, salud y medio ambiente específicas para la sustancia o lamezcla:
Seveso III:
No relevante
Emisión: 04/09/2019 Versión: 1
- CONTINÚA EN LA SIGUIENTE PÁGINA -
Documento generado con CHEMETER (www.siam-it.com)8/243
![Page 9: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/9.jpg)
901143 - ACIDO MALICO GRANULAR 20/25 MESH...
Ficha de datos de seguridadsegún 1907/2006/CE (REACH), 2015/830/EU
SECCIÓN 15: INFORMACIÓN REGLAMENTARIA (continúa)
Restricciones a la comercialización y al uso de ciertas sustancias y mezclas peligrosas (Anexo XVII delReglamento REACH, etc ...):
No relevante
Disposiciones particulares en materia de protección de las personas o el medio ambiente:
Se recomienda emplear la información recopilada en esta ficha de datos de seguridad como datos de entrada en una evaluaciónde riesgos de las circunstancias locales con el objeto de establecer las medidas necesarias de prevención de riesgos para elmanejo, utilización, almacenamiento y eliminación de este producto.
Otras legislaciones:
Reglamento (CE) n o 1272/2008 del Parlamento Europeo y del Consejo, de 16 de diciembre de 2008 , sobre clasificación,etiquetado y envasado de sustancias y mezclas, y por el que se modifican y derogan las Directivas 67/548/CEE y 1999/45/CE y semodifica el Reglamento (CE) n o 1907/2006 y todas sus modificaciones posteriores.
HACCP: Hazard analysis and critical control points, ISO: 22000
15.2 Evaluación de la seguridad química:
El proveedor no ha llevado a cabo evaluación de seguridad química.
SECCIÓN 16: OTRA INFORMACIÓN
Legislación aplicable a fichas de datos de seguridad:
Esta ficha de datos de seguridad se ha desarrollado de acuerdo al ANEXO II-Guía para la elaboración de Fichas de Datos deSeguridad del Reglamento (CE) Nº 1907/2006 (Reglamento (UE) nº 2015/830)
Modificaciones respecto a la ficha de seguridad anterior que afectan a las medidas de gestión del riesgo:
No relevante. Cambio de formato.Textos de las frases legislativas contempladas en la sección 2:
H319: Provoca irritación ocular grave
Textos de las frases legislativas contempladas en la sección 3:
Las frases indicadas no se refieren al producto en sí, son sólo a título informativo y hacen referencia a los componentesindividuales que aparecen en la sección 3
Reglamento nº1272/2008 (CLP):
Eye Irrit. 2: H319 - Provoca irritación ocular grave
Consejos relativos a la formación:
Se recomienda formación mínima en materia de prevención de riesgos laborales al personal que va a manipular este producto,con la finalidad de facilitar la comprensión e interpretación de esta ficha de datos de seguridad, así como del etiquetado delproducto.
Principales fuentes bibliográficas:
http://echa.europa.euhttp://eur-lex.europa.eu
Abreviaturas y acrónimos:
ADR: Acuerdo europeo relativo al transporte internacional de mercancías peligrosas por carreteraIMDG: Código Marítimo Internacional de Mercancías PeligrosasIATA: Asociación Internacional de Transporte AéreoOACI: Organización de Aviación Civil InternacionalDQO:Demanda Quimica de oxígenoDBO5:Demanda biológica de oxígeno a los 5 díasBCF: factor de bioconcentraciónDL50: dosis letal 50CL50: concentración letal 50EC50: concentración efectiva 50Log POW: logaritmo coeficiente partición octanol-aguaKoc: coeficiente de partición del carbono orgánicoFDS: Ficha de datos de seguridad
La información contenida en esta Ficha de datos de seguridad está fundamentada en fuentes, conocimientos técnicos y legislación vigente a nivel europeo y estatal, no pudiendo garantizar laexactitud de la misma. Esta información no es posible considerarla como una garantía de las propiedades del producto, se trata simplemente de una descripción en cuanto a los requerimientos enmateria de seguridad. La metodología y condiciones de trabajo de los usuarios de este producto se encuentran fuera de nuestro conocimiento y control, siendo siempre responsabilidad última delusuario tomar las medidas necesarias para adecuarse a las exigencias legislativas en cuanto a manipulación, almacenamiento, uso y eliminación de productos químicos. La información de estaficha de seguridad únicamente se refiere a este producto, el cual no debe emplearse con fines distintos a los que se especifican.
Emisión: 04/09/2019 Versión: 1
- FIN DE LA FICHA DE SEGURIDAD -
Documento generado con CHEMETER (www.siam-it.com)9/243
![Page 10: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/10.jpg)
Malic Acid
Revision: 8 Page: 8/241 Date: 27/10/2015
Section 1: Title of exposure scenario
Contributing scenario controlling environmental exposure
ERC2 Formulation of mixture in closed and open systems
Contributing scenario controlling worker exposure
PROC1 Use in closed process, no likelihood of exposure PROC2 Use in closed, continuous process with occasional controlled exposure PROC4 Use in batch and other process (synthesis) where opportunity for exposure arises PROC8b Receiving and charging of the substance PROC3 Mixing, dispersing, completion in closed batch process PROC5 Mixing, dispersing and completion in open multistage batch process PROC8a Transfer in non-dedicated facilities PROC8b Transfer at dedicated facilities PROC9 Filling small containers in dedicated lines PROC8a Maintenance and cleaning operations PROC15 Use as laboratory reagent
Section 2: Operational conditions of use
Contributing scenario controlling environmental exposure (1)
ERC2 Formulation of mixture in closed and open systems
Amounts used, Frequency and duration of use
Daily use at site ≤ 0.45 tonnes/day
Annual use at site ≤ 100 tonnes/year
Percentage of tonnage used at regional scale
100%
Conditions and measures related to municipal sewage treatment plant
Municipal STP Yes. [Effectiveness - Water: 87.34%]
Discharge rate of STP ≥ 2 X 103 m3/days
Application of the STP sludge on agricultural soil
Yes
Conditions and measures related to external treatment of waste for disposal
10/243
![Page 11: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/11.jpg)
Malic Acid
Revision: 8 Page: 9/241 Date: 27/10/2015
Particular considerations on the waste treatment operations: No (low risk) (ERC based assessment demonstrating control of risk with default conditions. Low risk assumed for waste life stage. Waste disposal according to national/local legislation is sufficient.)
Other given operational conditions affecting environmental exposure
Receiving surface water flow ≥ 1.8 X 104 m3/days
Contributing scenario controlling worker exposure (1)
PROC1 Use in closed process, no likelihood of exposure
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Use in closed systems. (minimal contact during routine operations)
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 80%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed One hand face only (240 cm2)
Contributing scenario controlling worker exposure (2)
PROC2 Use in closed, continuous process with occasional controlled exposure
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour) 11/243
![Page 12: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/12.jpg)
Malic Acid
Revision: 8 Page: 10/241 Date: 27/10/2015
Containment Closed continuous process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 80%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (3)
PROC4 Use in batch and other process (synthesis) where opportunity for exposure arises
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 80%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (4)
PROC8b Receiving and charging of the substance
Product (article) characteristic 12/243
![Page 13: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/13.jpg)
Malic Acid
Revision: 8 Page: 11/241 Date: 27/10/2015
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (5)
PROC3 Mixing, dispersing, completion in closed batch process
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Closed batch process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield 13/243
![Page 14: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/14.jpg)
Malic Acid
Revision: 8 Page: 12/241 Date: 27/10/2015
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed One hand face only (240 cm2)
Contributing scenario controlling worker exposure (6)
PROC5 Mixing, dispersing and completion in open multistage batch process
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (7)
PROC8a Transfer in non-dedicated facilities
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour) 14/243
![Page 15: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/15.jpg)
Malic Acid
Revision: 8 Page: 13/241 Date: 27/10/2015
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (8)
PROC8b Transfer at dedicated facilities
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (9)
PROC9 Filling small containers in dedicated lines
Product (article) characteristic 15/243
![Page 16: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/16.jpg)
Malic Acid
Revision: 8 Page: 14/241 Date: 27/10/2015
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (10)
PROC8a Maintenance and cleaning operations
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield 16/243
![Page 17: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/17.jpg)
Malic Acid
Revision: 8 Page: 15/241 Date: 27/10/2015
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (11)
PROC15 Use as laboratory reagent
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 80%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed One hand face only (240 cm2)
Section 3: Exposure estimation and reference to its source
Contributing scenario controlling environmental exposure (1)
ERC2 Formulation of mixture in closed and open systems
Release route Release rate Release estimation method
Water 9 kg/day ERC based
Air 11.25 kg/day ERC based
Soil 0.045 kg/day ERC based
Protection target Exposure estimation Risk characterisation ratio
Fresh water 0.057 mg/L 0.572
Sea water 0.006 mg/L 0.572 17/243
![Page 18: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/18.jpg)
Malic Acid
Revision: 8 Page: 16/241 Date: 27/10/2015
Sewage treatment plant 0.57 mg/L 0.19
Man via Environment - Inhalation 0.002 mg/m³ <0.01
Man via Environment - Oral 0.278 mg/kg bw/day 0.046
Contributing scenario controlling worker exposure (1)
PROC1 Use in closed process, no likelihood of exposure
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.01 mg/m³ <0.01
Inhalation, Systemic effects, Acute 0.04 mg/m³ <0.01 Inhalation, Local effects, Long Term
0.01 mg/m³ <0.01
Inhalation, Local effects, Acute 0.04 mg/m³ <0.01 Dermal, Systemic effects, Long Term
0.007 mg/kg bw/day <0.01
Dermal, Local effects, Long Term 0.002 mg/cm2 <0.01 Combined routes, Systemic effects, Long Term
- <0.01
Combined routes, Systemic effects, Acute
- <0.01
Contributing scenario controlling worker exposure (2)
PROC2 Use in closed, continuous process with occasional controlled exposure
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.01 mg/m³ <0.01
Inhalation, Systemic effects, Acute 0.04 mg/m³ <0.01 Inhalation, Local effects, Long Term
0.01 mg/m³ <0.01
Inhalation, Local effects, Acute 0.04 mg/m³ <0.01 Dermal, Systemic effects, Long Term
0.274 mg/kg bw/day 0.137
Dermal, Local effects, Long Term 0.04 mg/cm2 0.04 Combined routes, Systemic effects, Long Term
- 0.139
Combined routes, Systemic effects, Acute
- <0.01
18/243
![Page 19: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/19.jpg)
Malic Acid
Revision: 8 Page: 17/241 Date: 27/10/2015
Contributing scenario controlling worker exposure (3)
PROC4 Use in batch and other process (synthesis) where opportunity for exposure arises
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019 Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019 Dermal, Systemic effects, Long Term
1.372 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.2 mg/cm2 0.2 Combined routes, Systemic effects, Long Term
- 0.78
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (4)
PROC8b Receiving and charging of the substance
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ <0.01 Inhalation, Local effects, Long Term
0.1 mg/m³ <0.01
Inhalation, Local effects, Acute 0.4 mg/m³ <0.01 Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1 Combined routes, Systemic effects, Long Term
- 0.704
Combined routes, Systemic effects, Acute
- <0.01
19/243
![Page 20: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/20.jpg)
Malic Acid
Revision: 8 Page: 18/241 Date: 27/10/2015
Contributing scenario controlling worker exposure (5)
PROC3 Mixing, dispersing, completion in closed batch process
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ <0.01 Inhalation, Local effects, Long Term
0.1 mg/m³ <0.01
Inhalation, Local effects, Acute 0.4 mg/m³ <0.01 Dermal, Systemic effects, Long Term
0.069 mg/kg bw/day 0.034
Dermal, Local effects, Long Term 0.02 mg/cm2 0.02 Combined routes, Systemic effects, Long Term
- 0.053
Combined routes, Systemic effects, Acute
- <0.01
Contributing scenario controlling worker exposure (6)
PROC5 Mixing, dispersing and completion in open multistage batch process
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019 Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019 Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.2 mg/cm2 0.2 Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (7)
PROC8a Transfer in non-dedicated facilities
Method: TRA Worker v3
20/243
![Page 21: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/21.jpg)
Malic Acid
Revision: 8 Page: 19/241 Date: 27/10/2015
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019 Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019 Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1 Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (8)
PROC8b Transfer at dedicated facilities
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ <0.01 Inhalation, Local effects, Long Term
0.1 mg/m³ <0.01
Inhalation, Local effects, Acute 0.4 mg/m³ <0.01 Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1 Combined routes, Systemic effects, Long Term
- 0.704
Combined routes, Systemic effects, Acute
- <0.01
21/243
![Page 22: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/22.jpg)
Malic Acid
Revision: 8 Page: 20/241 Date: 27/10/2015
Contributing scenario controlling worker exposure (9)
PROC9 Filling small containers in dedicated lines
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ <0.01 Inhalation, Local effects, Long Term
0.1 mg/m³ <0.01
Inhalation, Local effects, Acute 0.4 mg/m³ <0.01 Dermal, Systemic effects, Long Term
0.686 mg/kg bw/day 0.343
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1 Combined routes, Systemic effects, Long Term
- 0.362
Combined routes, Systemic effects, Acute
- <0.01
Contributing scenario controlling worker exposure (10)
PROC8a Maintenance and cleaning operations
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019 Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019 Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1 Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
22/243
![Page 23: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/23.jpg)
Malic Acid
Revision: 8 Page: 21/241 Date: 27/10/2015
Contributing scenario controlling worker exposure (11)
PROC15 Use as laboratory reagent
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ <0.01 Inhalation, Local effects, Long Term
0.1 mg/m³ <0.01
Inhalation, Local effects, Acute 0.4 mg/m³ <0.01 Dermal, Systemic effects, Long Term
0.068 mg/kg bw/day 0.034
Dermal, Local effects, Long Term 0.02 mg/cm2 0.02 Combined routes, Systemic effects, Long Term
- 0.053
Combined routes, Systemic effects, Acute
- <0.01
Section 4: Guidance to DU to evaluate whether he works inside the boundaries set by the ES
No additional risk management measures, besides those that are mentioned above, are needed to guarantee safe use for workers.
Exposure Scenario 2: Use at industrial site - Substance incorporated into article
Section 1: Title of exposure scenario
Contributing scenario controlling environmental exposure
ERC5 Uses for industrial manual electroplating surface treatment
Contributing scenario controlling worker exposure
PROC8b Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities PROC2 Use in closed, continuous process with occasional controlled exposure - Metal cleaner (degreaser, descaler, etch); Automatic process PROC10 Roller application or brushing - Metal cleaner (degreaser, descaler, etch); Manual process PROC7 Industrial spraying PROC13 Treatment of articles by dipping and pouring PROC15 Use as laboratory reagent
Section 2: Operational conditions of use
Contributing scenario controlling environmental exposure (1)
ERC5 Uses for industrial manual electroplating surface treatment
Amounts used, Frequency and duration of use
Daily use at site ≤ 0.45 tonnes/day 23/243
![Page 24: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/24.jpg)
Malic Acid
Revision: 8 Page: 22/241 Date: 27/10/2015
Annual use at site ≤ 100 tonnes/year
Percentage of tonnage used at regional scale
100%
Conditions and measures related to municipal sewage treatment plant
Municipal STP Yes. [Effectiveness - Water: 87.34%]
Discharge rate of STP ≥ 2 X 103 m3/days
Application of the STP sludge on agricultural soil
Yes
Conditions and measures related to external treatment of waste for disposal
Particular considerations on the waste treatment operations: No (low risk) (ERC based assessment demonstrating control of risk with default conditions. Low risk assumed for waste life stage. Waste disposal according to national/local legislation is sufficient.)
Other given operational conditions affecting environmental exposure
Receiving surface water flow ≥ 1.8 X 104 m3/days
Contributing scenario controlling worker exposure (1)
PROC8b Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Good general ventilation (3-5 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 95%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
24/243
![Page 25: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/25.jpg)
Malic Acid
Revision: 8 Page: 23/241 Date: 27/10/2015
Contributing scenario controlling worker exposure (2)
PROC2 Use in closed, continuous process with occasional controlled exposure - Metal cleaner (degreaser, descaler, etch); Automatic process
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Good general ventilation (3-5 air changes per hour)
Containment Closed continuous process with occasional controlled exposure
Local exhaust ventilation Yes. [Effectiveness - Inhalation: 90%]
Local exhaust ventilation (Dermal) No. [Effectiveness - Dermal: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 95%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (3)
PROC10 Roller application or brushing - Metal cleaner (degreaser, descaler, etch); Manual process
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Good general ventilation (3-5 air changes per hour)
Containment No.
Local exhaust ventilation Yes. [Effectiveness - Inhalation: 90%]
Local exhaust ventilation (Dermal) No. [Effectiveness - Dermal: 0%] 25/243
![Page 26: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/26.jpg)
Malic Acid
Revision: 8 Page: 24/241 Date: 27/10/2015
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 95%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (4)
PROC7 Industrial spraying
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Good general ventilation (3-5 air changes per hour)
Containment No.
Local exhaust ventilation Yes. [Effectiveness - Inhalation: 95%]
Local exhaust ventilation (Dermal) Yes. [Effectiveness - Dermal: 95%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 95%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands and upper wrists (1500 cm2)
Contributing scenario controlling worker exposure (5)
PROC13 Treatment of articles by dipping and pouring
Product (article) characteristic
Dustiness of material Low 26/243
![Page 27: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/27.jpg)
Malic Acid
Revision: 8 Page: 25/241 Date: 27/10/2015
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Good general ventilation (3-5 air changes per hour)
Containment No.
Local exhaust ventilation Yes. [Effectiveness - Inhalation: 90%]
Local exhaust ventilation (Dermal) No. [Effectiveness - Dermal: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 95%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (6)
PROC15 Use as laboratory reagent
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Good general ventilation (3-5 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 95%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield 27/243
![Page 28: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/28.jpg)
Malic Acid
Revision: 8 Page: 26/241 Date: 27/10/2015
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed One hand face only (240 cm2)
Section 3: Exposure estimation and reference to its source
Contributing scenario controlling environmental exposure (1)
ERC5 Uses for industrial manual electroplating surface treatment
Release route Release rate Release estimation method
Water 9 kg/day Release factor
Air 78.75 kg/day Release factor
Soil 1 % ERC based
Protection target Exposure estimation Risk characterisation ratio
Fresh water 0.057 mg/L 0.572
Sea water 0.006 mg/L 0.572
Sewage treatment plant 0.57 mg/L 0.19
Man via Environment - Inhalation 0.013 mg/m³ <0.01
Man via Environment - Oral 1.941 mg/kg bw/day 0.324
Contributing scenario controlling worker exposure (1)
PROC8b Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.07 mg/m³ 0.013
Inhalation, Systemic effects, Acute 0.28 mg/m³ <0.01
Inhalation, Local effects, Long Term
0.07 mg/m³ <0.01
Inhalation, Local effects, Acute 0.28 mg/m³ <0.01
Dermal, Systemic effects, Long Term
0.685 mg/kg bw/day 0.343
Dermal, Local effects, Long Term 0.05 mg/cm2 0.05
Combined routes, Systemic effects, Long Term
- 0.356
Combined routes, Systemic effects, Acute
- <0.01
Contributing scenario controlling worker exposure (2)
PROC2 Use in closed, continuous process with occasional controlled exposure - Metal cleaner (degreaser, descaler, etch); Automatic process 28/243
![Page 29: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/29.jpg)
Malic Acid
Revision: 8 Page: 27/241 Date: 27/10/2015
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
7 X 10-4 mg/m³ <0.01
Inhalation, Systemic effects, Acute 0.003 mg/m³ <0.01
Inhalation, Local effects, Long Term
7 X 10-4 mg/m³ <0.01
Inhalation, Local effects, Acute 0.003 mg/m³ <0.01
Dermal, Systemic effects, Long Term
0.069 mg/kg bw/day 0.034
Dermal, Local effects, Long Term 0.01 mg/cm2 <0.01
Combined routes, Systemic effects, Long Term
- 0.034
Combined routes, Systemic effects, Acute
- <0.01
Contributing scenario controlling worker exposure (3)
PROC10 Roller application or brushing - Metal cleaner (degreaser, descaler, etch); Manual process
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.035 mg/m³ <0.01
Inhalation, Systemic effects, Acute 0.14 mg/m³ <0.01
Inhalation, Local effects, Long Term
0.035 mg/m³ <0.01
Inhalation, Local effects, Acute 0.14 mg/m³ <0.01
Dermal, Systemic effects, Long Term
1.372 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.692
Combined routes, Systemic effects, Acute
- <0.01
Contributing scenario controlling worker exposure (4)
PROC7 Industrial spraying
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
29/243
![Page 30: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/30.jpg)
Malic Acid
Revision: 8 Page: 28/241 Date: 27/10/2015
Inhalation, Systemic effects, Long Term
0.035 mg/m³ <0.01
Inhalation, Systemic effects, Acute 0.14 mg/m³ <0.01
Inhalation, Local effects, Long Term
0.035 mg/m³ <0.01
Inhalation, Local effects, Acute 0.14 mg/m³ <0.01
Dermal, Systemic effects, Long Term
0.107 mg/kg bw/day 0.054
Dermal, Local effects, Long Term 0.005 mg/cm2 <0.01
Combined routes, Systemic effects, Long Term
- 0.06
Combined routes, Systemic effects, Acute
- <0.01
Contributing scenario controlling worker exposure (5)
PROC13 Treatment of articles by dipping and pouring
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.007 mg/m³ <0.01
Inhalation, Systemic effects, Acute 0.028 mg/m³ <0.01
Inhalation, Local effects, Long Term
0.007 mg/m³ <0.01
Inhalation, Local effects, Acute 0.028 mg/m³ <0.01
Dermal, Systemic effects, Long Term
0.685 mg/kg bw/day 0.343
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.344
Combined routes, Systemic effects, Acute
- <0.01
Contributing scenario controlling worker exposure (6)
PROC15 Use as laboratory reagent
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.07 mg/m³ 0.013
Inhalation, Systemic effects, Acute 0.28 mg/m³ <0.01 30/243
![Page 31: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/31.jpg)
Malic Acid
Revision: 8 Page: 29/241 Date: 27/10/2015
Inhalation, Local effects, Long Term
0.07 mg/m³ <0.01
Inhalation, Local effects, Acute 0.28 mg/m³ <0.01
Dermal, Systemic effects, Long Term
0.017 mg/kg bw/day <0.01
Dermal, Local effects, Long Term 0.005 mg/cm2 <0.01
Combined routes, Systemic effects, Long Term
- 0.022
Combined routes, Systemic effects, Acute
- <0.01
Section 4: Guidance to DU to evaluate whether he works inside the boundaries set by the ES
No additional risk management measures, besides those that are mentioned above, are needed to guarantee safe use for workers.
Exposure Scenario 3: Formulation - SpERC: AISE 2.1b.V2 - (granular cleaning and
maintenance products: medium scale)
Section 1: Title of exposure scenario
Contributing scenario controlling environmental exposure
ERC2 Formulation - water treatment and washing and cleaning products
Contributing scenario controlling worker exposure
PROC8b Receiving and charging of the substance PROC3 Mixing, dispersing, completion in closed batch process PROC5 Mixing, dispersing and completion in open multistage batch process PROC8a Transfer in non-dedicated facilities PROC8b Transfer at dedicated facilities PROC9 Filling small containers in dedicated lines PROC8a Maintenance and cleaning operations
Section 2: Operational conditions of use
Contributing scenario controlling environmental exposure (1)
ERC2 Formulation - water treatment and washing and cleaning products
Amounts used, Frequency and duration of use
Daily use at site ≤ 4.5 tonnes/day
Annual use at site ≤ 150 tonnes/year
Percentage of tonnage used at regional scale
100%
Conditions and measures related to municipal sewage treatment plant
Municipal STP Yes. [Effectiveness - Water: 87.34%]
Discharge rate of STP ≥ 2 X 103 m3/days
31/243
![Page 32: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/32.jpg)
Malic Acid
Revision: 8 Page: 30/241 Date: 27/10/2015
Application of the STP sludge on agricultural soil
Yes
Conditions and measures related to external treatment of waste for disposal
Particular considerations on the waste treatment operations: No (low risk) (ERC based assessment demonstrating control of risk with default conditions. Low risk assumed for waste life stage. Waste disposal according to national/local legislation is sufficient.)
Other given operational conditions affecting environmental exposure
Receiving surface water flow ≥ 1.8 X 104 m3/days
Contributing scenario controlling worker exposure (1)
PROC8b Receiving and charging of the substance
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Good general ventilation (3-5 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 95%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (2)
PROC3 Mixing, dispersing, completion in closed batch process
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use 32/243
![Page 33: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/33.jpg)
Malic Acid
Revision: 8 Page: 31/241 Date: 27/10/2015
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Good general ventilation (3-5 air changes per hour)
Containment Closed continuous process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 95%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed One hand face only (240 cm2)
Contributing scenario controlling worker exposure (3)
PROC5 Mixing, dispersing and completion in open multistage batch process
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Good general ventilation (3-5 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 95%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient 33/243
![Page 34: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/34.jpg)
Malic Acid
Revision: 8 Page: 32/241 Date: 27/10/2015
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (4)
PROC8a Transfer in non-dedicated facilities
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Good general ventilation (3-5 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 95%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (5)
PROC8b Transfer at dedicated facilities
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Good general ventilation (3-5 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced 34/243
![Page 35: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/35.jpg)
Malic Acid
Revision: 8 Page: 33/241 Date: 27/10/2015
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 95%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (6)
PROC9 Filling small containers in dedicated lines
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Good general ventilation (3-5 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 95%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (7)
PROC8a Maintenance and cleaning operations
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
35/243
![Page 36: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/36.jpg)
Malic Acid
Revision: 8 Page: 34/241 Date: 27/10/2015
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Good general ventilation (3-5 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 95%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Section 3: Exposure estimation and reference to its source
Contributing scenario controlling environmental exposure (1)
ERC2 Formulation - water treatment and washing and cleaning products
Release route Release rate Release estimation method
Water 4.5 kg/day SpERC based
Air 0 kg/day SpERC based
Soil 0 % SpERC based
Protection target Exposure estimation Risk characterisation ratio
Fresh water 0.029 mg/L 0.287
Sea water 0.003 mg/L 0.287
Sewage treatment plant 0.285 mg/L 0.095
Man via Environment - Inhalation 3.014 X 10-11 mg/m³ <0.01
Man via Environment - Oral 1.328 X 10-4 mg/kg bw/day <0.01
Contributing scenario controlling worker exposure (1)
PROC8b Receiving and charging of the substance
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.07 mg/m³ 0.013
36/243
![Page 37: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/37.jpg)
Malic Acid
Revision: 8 Page: 35/241 Date: 27/10/2015
Inhalation, Systemic effects, Acute 0.28 mg/m³ <0.01
Inhalation, Local effects, Long Term
0.07 mg/m³ <0.01
Inhalation, Local effects, Acute 0.28 mg/m³ <0.01
Dermal, Systemic effects, Long Term
0.685 mg/kg bw/day 0.343
Dermal, Local effects, Long Term 0.05 mg/cm2 0.05
Combined routes, Systemic effects, Long Term
- 0.356
Combined routes, Systemic effects, Acute
- <0.01
Contributing scenario controlling worker exposure (2)
PROC3 Mixing, dispersing, completion in closed batch process
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.07 mg/m³ 0.013
Inhalation, Systemic effects, Acute 0.28 mg/m³ <0.01
Inhalation, Local effects, Long Term
0.07 mg/m³ <0.01
Inhalation, Local effects, Acute 0.28 mg/m³ <0.01
Dermal, Systemic effects, Long Term
0.035 mg/kg bw/day 0.017
Dermal, Local effects, Long Term 0.01 mg/cm2 0.01
Combined routes, Systemic effects, Long Term
- 0.03
Combined routes, Systemic effects, Acute
- <0.01
Contributing scenario controlling worker exposure (3)
PROC5 Mixing, dispersing and completion in open multistage batch process
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.35 mg/m³ 0.066
Inhalation, Systemic effects, Acute 1.4 mg/m³ 0.013
Inhalation, Local effects, Long Term
0.35 mg/m³ 0.011
Inhalation, Local effects, Acute 1.4 mg/m³ 0.013
Dermal, Systemic effects, 0.685 mg/kg bw/day 0.343 37/243
![Page 38: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/38.jpg)
Malic Acid
Revision: 8 Page: 36/241 Date: 27/10/2015
Long Term
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.408
Combined routes, Systemic effects, Acute
- 0.013
Contributing scenario controlling worker exposure (4)
PROC8a Transfer in non-dedicated facilities
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.35 mg/m³ 0.066
Inhalation, Systemic effects, Acute 1.4 mg/m³ 0.013
Inhalation, Local effects, Long Term
0.35 mg/m³ 0.011
Inhalation, Local effects, Acute 1.4 mg/m³ 0.013
Dermal, Systemic effects, Long Term
0.685 mg/kg bw/day 0.343
Dermal, Local effects, Long Term 0.05 mg/cm2 0.05
Combined routes, Systemic effects, Long Term
- 0.408
Combined routes, Systemic effects, Acute
- 0.013
Contributing scenario controlling worker exposure (5)
PROC8b Transfer at dedicated facilities
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.07 mg/m³ 0.013
Inhalation, Systemic effects, Acute 0.28 mg/m³ <0.01
Inhalation, Local effects, Long Term
0.07 mg/m³ <0.01
Inhalation, Local effects, Acute 0.28 mg/m³ <0.01
Dermal, Systemic effects, Long Term
0.685 mg/kg bw/day 0.343
Dermal, Local effects, Long Term 0.05 mg/cm2 0.05
Combined routes, Systemic effects, Long Term
- 0.356
Combined routes, Systemic - <0.01 38/243
![Page 39: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/39.jpg)
Malic Acid
Revision: 8 Page: 37/241 Date: 27/10/2015
effects, Acute
Contributing scenario controlling worker exposure (6)
PROC9 Filling small containers in dedicated lines
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.07 mg/m³ 0.013
Inhalation, Systemic effects, Acute 0.28 mg/m³ <0.01
Inhalation, Local effects, Long Term
0.07 mg/m³ <0.01
Inhalation, Local effects, Acute 0.28 mg/m³ <0.01
Dermal, Systemic effects, Long Term
0.343 mg/kg bw/day 0.172
Dermal, Local effects, Long Term 0.05 mg/cm2 0.05
Combined routes, Systemic effects, Long Term
- 0.185
Combined routes, Systemic effects, Acute
- <0.01
Contributing scenario controlling worker exposure (7)
PROC8a Maintenance and cleaning operations
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.35 mg/m³ 0.066
Inhalation, Systemic effects, Acute 1.4 mg/m³ 0.013
Inhalation, Local effects, Long Term
0.35 mg/m³ 0.011
Inhalation, Local effects, Acute 1.4 mg/m³ 0.013
Dermal, Systemic effects, Long Term
0.685 mg/kg bw/day 0.343
Dermal, Local effects, Long Term 0.05 mg/cm2 0.05
Combined routes, Systemic effects, Long Term
- 0.408
Combined routes, Systemic effects, Acute
- 0.013
Section 4: Guidance to DU to evaluate whether he works inside the boundaries set by the ES
No additional risk management measures, besides those that are mentioned above, are needed to guarantee safe use for workers.
39/243
![Page 40: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/40.jpg)
Malic Acid
Revision: 8 Page: 38/241 Date: 27/10/2015
Exposure Scenario 4: Formulation - SpERC: AISE 2.1b.V2 - (Liquid cleaning and
maintenance products: low viscosity: medium scale)
Section 1: Title of exposure scenario
Contributing scenario controlling environmental exposure
ERC2 Formulation
Contributing scenario controlling worker exposure
PROC8b Receiving and charging of the substance PROC3 Mixing, dispersing, completion in closed batch process PROC5 Mixing, dispersing and completion in open multistage batch process PROC8a Transfer in non-dedicated facilities PROC8b Transfer at dedicated facilities PROC9 Filling small containers in dedicated lines PROC8a Maintenance and cleaning operations
Section 2: Operational conditions of use
Contributing scenario controlling environmental exposure (1)
ERC2 Formulation
Amounts used, Frequency and duration of use
Daily use at site ≤ 4.5 tonnes/day
Annual use at site ≤ 150 tonnes/year
Percentage of tonnage used at regional scale
100%
Conditions and measures related to municipal sewage treatment plant
Municipal STP Yes. [Effectiveness - Water: 87.34%]
Discharge rate of STP ≥ 2 X 103 m3/days
Application of the STP sludge on agricultural soil
Yes
Conditions and measures related to external treatment of waste for disposal
Particular considerations on the waste treatment operations: No (low risk) (ERC based assessment demonstrating control of risk with default conditions. Low risk assumed for waste life stage. Waste disposal according to national/local legislation is sufficient.)
Other given operational conditions affecting environmental exposure
Receiving surface water flow ≥ 1.8 X 104 m3/days
Contributing scenario controlling worker exposure (1)
PROC8b Receiving and charging of the substance
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use 40/243
![Page 41: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/41.jpg)
Malic Acid
Revision: 8 Page: 39/241 Date: 27/10/2015
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Good general ventilation (3-5 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 95%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (2)
PROC3 Mixing, dispersing, completion in closed batch process
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Good general ventilation (3-5 air changes per hour)
Containment Closed continuous process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 95%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient 41/243
![Page 42: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/42.jpg)
Malic Acid
Revision: 8 Page: 40/241 Date: 27/10/2015
Skin surface potentially exposed One hand face only (240 cm2)
Contributing scenario controlling worker exposure (3)
PROC5 Mixing, dispersing and completion in open multistage batch process
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Good general ventilation (3-5 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 95%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (4)
PROC8a Transfer in non-dedicated facilities
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Good general ventilation (3-5 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced 42/243
![Page 43: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/43.jpg)
Malic Acid
Revision: 8 Page: 41/241 Date: 27/10/2015
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 95%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (5)
PROC8b Transfer at dedicated facilities
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Good general ventilation (3-5 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 95%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (6)
PROC9 Filling small containers in dedicated lines
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
43/243
![Page 44: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/44.jpg)
Malic Acid
Revision: 8 Page: 42/241 Date: 27/10/2015
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Good general ventilation (3-5 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 95%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (7)
PROC8a Maintenance and cleaning operations
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Good general ventilation (3-5 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 95%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use 44/243
![Page 45: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/45.jpg)
Malic Acid
Revision: 8 Page: 43/241 Date: 27/10/2015
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Section 3: Exposure estimation and reference to its source
Contributing scenario controlling environmental exposure (1)
ERC2 Formulation
Release route Release rate Release estimation method
Water 4.5 kg/day SpERC based
Air 0 kg/day SpERC based
Soil 0 % SpERC based
Protection target Exposure estimation Risk characterisation ratio
Fresh water 0.029 mg/L 0.287
Sea water 0.003 mg/L 0.287
Sewage treatment plant 0.285 mg/L 0.095
Man via Environment - Inhalation 3.014 X 10-11 mg/m³ <0.01
Man via Environment - Oral 1.328 X 10-4 mg/kg bw/day <0.01
Contributing scenario controlling worker exposure (1)
PROC8b Receiving and charging of the substance
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.07 mg/m³ 0.013
Inhalation, Systemic effects, Acute 0.28 mg/m³ <0.01
Inhalation, Local effects, Long Term
0.07 mg/m³ <0.01
Inhalation, Local effects, Acute 0.28 mg/m³ <0.01
Dermal, Systemic effects, Long Term
0.685 mg/kg bw/day 0.343
Dermal, Local effects, Long Term 0.05 mg/cm2 0.05
Combined routes, Systemic effects, Long Term
- 0.356
Combined routes, Systemic effects, Acute
- <0.01
Contributing scenario controlling worker exposure (2)
PROC3 Mixing, dispersing, completion in closed batch process
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
45/243
![Page 46: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/46.jpg)
Malic Acid
Revision: 8 Page: 44/241 Date: 27/10/2015
Inhalation, Systemic effects, Long Term
0.07 mg/m³ 0.013
Inhalation, Systemic effects, Acute 0.28 mg/m³ <0.01
Inhalation, Local effects, Long Term
0.07 mg/m³ <0.01
Inhalation, Local effects, Acute 0.28 mg/m³ <0.01
Dermal, Systemic effects, Long Term
0.035 mg/kg bw/day 0.017
Dermal, Local effects, Long Term 0.01 mg/cm2 0.01
Combined routes, Systemic effects, Long Term
- 0.03
Combined routes, Systemic effects, Acute
- <0.01
Contributing scenario controlling worker exposure (3)
PROC5 Mixing, dispersing and completion in open multistage batch process
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.35 mg/m³ 0.066
Inhalation, Systemic effects, Acute 1.4 mg/m³ 0.013
Inhalation, Local effects, Long Term
0.35 mg/m³ 0.011
Inhalation, Local effects, Acute 1.4 mg/m³ 0.013
Dermal, Systemic effects, Long Term
0.685 mg/kg bw/day 0.343
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.408
Combined routes, Systemic effects, Acute
- 0.013
Contributing scenario controlling worker exposure (4)
PROC8a Transfer in non-dedicated facilities
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.35 mg/m³ 0.066
Inhalation, Systemic effects, Acute 1.4 mg/m³ 0.013
Inhalation, Local effects, Long Term
0.35 mg/m³ 0.011
46/243
![Page 47: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/47.jpg)
Malic Acid
Revision: 8 Page: 45/241 Date: 27/10/2015
Inhalation, Local effects, Acute 1.4 mg/m³ 0.013
Dermal, Systemic effects, Long Term
0.685 mg/kg bw/day 0.343
Dermal, Local effects, Long Term 0.05 mg/cm2 0.05
Combined routes, Systemic effects, Long Term
- 0.408
Combined routes, Systemic effects, Acute
- 0.013
Contributing scenario controlling worker exposure (5)
PROC8b Transfer at dedicated facilities
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.07 mg/m³ 0.013
Inhalation, Systemic effects, Acute 0.28 mg/m³ <0.01
Inhalation, Local effects, Long Term
0.07 mg/m³ <0.01
Inhalation, Local effects, Acute 0.28 mg/m³ <0.01
Dermal, Systemic effects, Long Term
0.685 mg/kg bw/day 0.343
Dermal, Local effects, Long Term 0.05 mg/cm2 0.05
Combined routes, Systemic effects, Long Term
- 0.356
Combined routes, Systemic effects, Acute
- <0.01
Contributing scenario controlling worker exposure (6)
PROC9 Filling small containers in dedicated lines
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.07 mg/m³ 0.013
Inhalation, Systemic effects, Acute 0.28 mg/m³ <0.01
Inhalation, Local effects, Long Term
0.07 mg/m³ <0.01
Inhalation, Local effects, Acute 0.28 mg/m³ <0.01
Dermal, Systemic effects, Long Term
0.343 mg/kg bw/day 0.172
Dermal, Local effects, Long Term 0.05 mg/cm2 0.05
Combined routes, Systemic - 0.185 47/243
![Page 48: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/48.jpg)
Malic Acid
Revision: 8 Page: 46/241 Date: 27/10/2015
effects, Long Term
Combined routes, Systemic effects, Acute
- <0.01
Contributing scenario controlling worker exposure (7)
PROC8a Maintenance and cleaning operations
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.35 mg/m³ 0.066
Inhalation, Systemic effects, Acute 1.4 mg/m³ 0.013
Inhalation, Local effects, Long Term
0.35 mg/m³ 0.011
Inhalation, Local effects, Acute 1.4 mg/m³ 0.013
Dermal, Systemic effects, Long Term
0.685 mg/kg bw/day 0.343
Dermal, Local effects, Long Term 0.05 mg/cm2 0.05
Combined routes, Systemic effects, Long Term
- 0.408
Combined routes, Systemic effects, Acute
- 0.013
Section 4: Guidance to DU to evaluate whether he works inside the boundaries set by the ES
No additional risk management measures, besides those that are mentioned above, are needed to guarantee safe use for workers.
48/243
![Page 49: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/49.jpg)
Malic Acid
Revision: 8 Page: 47/241 Date: 27/10/2015
Exposure Scenario 5: Use at industrial site: Intermediate
Section 1: Title of exposure scenario
Sectors of use [SU] SU8 Manufacture of bulk, large scale chemicals (including petroleum products) SU9 Manufacture of fine chemicals
Contributing scenario controlling environmental exposure
ERC6a Use at industrial site: Intermediate
Contributing scenario controlling worker exposure
PROC8a Transfer in non-dedicated facilities PROC8b Transfer at dedicated facilities PROC8b Receiving and charging of the substance PROC1 Use in closed process, no likelihood of exposure PROC2 Use in closed, continuous process with occasional controlled exposure PROC3 Use in closed batch process (synthesis or formulation) PROC4 Use in batch and other process (synthesis) where opportunity for exposure arises PROC15 Use as laboratory reagent
Section 2: Operational conditions of use
Contributing scenario controlling environmental exposure (1)
ERC6a Use at industrial site: Intermediate
Amounts used, Frequency and duration of use
Daily use at site ≤ 0.45 tonnes/day
Annual use at site ≤ 100 tonnes/year
Percentage of tonnage used at regional scale
100%
Conditions and measures related to municipal sewage treatment plant
Municipal STP Yes. [Effectiveness - Water: 87.34%]
Discharge rate of STP ≥ 2 X 103 m3/days
Application of the STP sludge on agricultural soil
Yes
Conditions and measures related to external treatment of waste for disposal
Particular considerations on the waste treatment operations: No (low risk) (ERC based assessment demonstrating control of risk with default conditions. Low risk assumed for waste life stage. Waste disposal according to national/local legislation is sufficient.)
Other given operational conditions affecting environmental exposure
Receiving surface water flow ≥ 1.8 X 104 m3/days
Contributing scenario controlling worker exposure (1)
PROC8a Transfer in non-dedicated facilities
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such 49/243
![Page 50: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/50.jpg)
Malic Acid
Revision: 8 Page: 48/241 Date: 27/10/2015
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (2)
PROC8b Transfer at dedicated facilities
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use 50/243
![Page 51: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/51.jpg)
Malic Acid
Revision: 8 Page: 49/241 Date: 27/10/2015
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (3)
PROC8b Receiving and charging of the substance
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (4)
PROC1 Use in closed process, no likelihood of exposure
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Use in closed systems. (minimal contact during routine operations)
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%] 51/243
![Page 52: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/52.jpg)
Malic Acid
Revision: 8 Page: 50/241 Date: 27/10/2015
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 80%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed One hand face only (240 cm2)
Contributing scenario controlling worker exposure (5) PROC2 Use in closed, continuous process with occasional controlled exposure
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Closed continuous process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 80%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (6) PROC3 Use in closed batch process (synthesis or formulation)
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such 52/243
![Page 53: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/53.jpg)
Malic Acid
Revision: 8 Page: 51/241 Date: 27/10/2015
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Closed batch process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 80%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed One hand face only (240 cm2)
Contributing scenario controlling worker exposure (7)
PROC4 Use in batch and other process (synthesis) where opportunity for exposure arises
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 80%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use 53/243
![Page 54: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/54.jpg)
Malic Acid
Revision: 8 Page: 52/241 Date: 27/10/2015
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (8)
PROC15 Use as laboratory reagent
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 80%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed One hand face only (240 cm2)
Section 3: Exposure estimation and reference to its source
Contributing scenario controlling environmental exposure (1)
ERC6a Use at industrial site: Intermediate
Release route Release rate Release estimation method
Water 9 kg/day ERC based
Air 22.5 kg/day ERC based
Soil 0.45 kg/day ERC based
Protection target Exposure estimation Risk characterisation ratio
Fresh water 0.057 mg/L 0.572
Sea water 0.006 mg/L 0.572
Sewage treatment plant 0.57 mg/L 0.19
Man via Environment - Inhalation 0.004 mg/m³ <0.01 54/243
![Page 55: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/55.jpg)
Malic Acid
Revision: 8 Page: 53/241 Date: 27/10/2015
Man via Environment - Oral 0.555 mg/kg bw/day 0.093
Contributing scenario controlling worker exposure (1)
PROC8a Transfer in non-dedicated facilities
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019 Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019 Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1 Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (2)
PROC8b Transfer at dedicated facilities
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ <0.01 Inhalation, Local effects, Long Term
0.1 mg/m³ <0.01
Inhalation, Local effects, Acute 0.4 mg/m³ <0.01 Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1 Combined routes, Systemic effects, Long Term
- 0.704
Combined routes, Systemic effects, Acute
- <0.01
55/243
![Page 56: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/56.jpg)
Malic Acid
Revision: 8 Page: 54/241 Date: 27/10/2015
Contributing scenario controlling worker exposure (3)
PROC8b Receiving and charging of the substance
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ <0.01 Inhalation, Local effects, Long Term
0.1 mg/m³ <0.01
Inhalation, Local effects, Acute 0.4 mg/m³ <0.01 Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1 Combined routes, Systemic effects, Long Term
- 0.704
Combined routes, Systemic effects, Acute
- <0.01
Contributing scenario controlling worker exposure (4)
PROC1 Use in closed process, no likelihood of exposure
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.01 mg/m³ <0.01
Inhalation, Systemic effects, Acute 0.04 mg/m³ <0.01 Inhalation, Local effects, Long Term
0.01 mg/m³ <0.01
Inhalation, Local effects, Acute 0.04 mg/m³ <0.01 Dermal, Systemic effects, Long Term
0.007 mg/kg bw/day <0.01
Dermal, Local effects, Long Term 0.002 mg/cm2 <0.01 Combined routes, Systemic effects, Long Term
- <0.01
Combined routes, Systemic effects, Acute
- <0.01
Contributing scenario controlling worker exposure (5) PROC2 Use in closed, continuous process with occasional controlled exposure
Method: TRA Worker v3
56/243
![Page 57: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/57.jpg)
Malic Acid
Revision: 8 Page: 55/241 Date: 27/10/2015
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.01 mg/m³ <0.01
Inhalation, Systemic effects, Acute 0.04 mg/m³ <0.01 Inhalation, Local effects, Long Term
0.01 mg/m³ <0.01
Inhalation, Local effects, Acute 0.04 mg/m³ <0.01 Dermal, Systemic effects, Long Term
0.274 mg/kg bw/day 0.137
Dermal, Local effects, Long Term 0.04 mg/cm2 0.04 Combined routes, Systemic effects, Long Term
- 0.139
Combined routes, Systemic effects, Acute
- <0.01
Contributing scenario controlling worker exposure (6) PROC3 Use in closed batch process (synthesis or formulation)
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ <0.01 Inhalation, Local effects, Long Term
0.1 mg/m³ <0.01
Inhalation, Local effects, Acute 0.4 mg/m³ <0.01 Dermal, Systemic effects, Long Term
0.138 mg/kg bw/day 0.069
Dermal, Local effects, Long Term 0.04 mg/cm2 0.04 Combined routes, Systemic effects, Long Term
- 0.088
Combined routes, Systemic effects, Acute
- <0.01
Contributing scenario controlling worker exposure (7)
PROC4 Use in batch and other process (synthesis) where opportunity for exposure arises
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019 57/243
![Page 58: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/58.jpg)
Malic Acid
Revision: 8 Page: 56/241 Date: 27/10/2015
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019 Dermal, Systemic effects, Long Term
1.372 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.2 mg/cm2 0.2 Combined routes, Systemic effects, Long Term
- 0.78
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (8)
PROC15 Use as laboratory reagent
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ <0.01 Inhalation, Local effects, Long Term
0.1 mg/m³ <0.01
Inhalation, Local effects, Acute 0.4 mg/m³ <0.01 Dermal, Systemic effects, Long Term
0.068 mg/kg bw/day 0.034
Dermal, Local effects, Long Term 0.02 mg/cm2 0.02 Combined routes, Systemic effects, Long Term
- 0.053
Combined routes, Systemic effects, Acute
- <0.01
Section 4: Guidance to DU to evaluate whether he works inside the boundaries set by the ES
No additional risk management measures, besides those that are mentioned above, are needed to guarantee safe use for workers. 58/243
![Page 59: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/59.jpg)
Malic Acid
Revision: 8 Page: 57/241 Date: 27/10/2015
Exposure Scenario 6: Formulation of water treatment and washing and cleaning products
Section 1: Title of exposure scenario
Chemical product category [PC] PC2 Adsorbents PC20 Products such as ph-regulators, flocculants, precipitants, neutralization agents PC35 Washing and cleaning products (including solvent based products) PC36 Water softeners PC37 Water treatment chemicals PC40 Extraction agents
Contributing scenario controlling environmental exposure
ERC2 Formulation of water treatment and washing and cleaning products
Contributing scenario controlling worker exposure
PROC1 Use in closed process, no likelihood of exposure PROC2 Use in closed, continuous process with occasional controlled exposure PROC4 Use in batch and other process (synthesis) where opportunity for exposure arises PROC8b Receiving and charging of the substance PROC3 Mixing, dispersing, completion in closed batch process PROC5 Mixing, dispersing and completion in open multistage batch process PROC8a Transfer in non-dedicated facilities PROC8b Transfer at dedicated facilities PROC9 Filling small containers in dedicated lines PROC8a Maintenance and cleaning operations PROC15 Use as laboratory reagent PROC21 Low energy manipulation of substances bound in materials and/or articles
Section 2: Operational conditions of use
Contributing scenario controlling environmental exposure (1)
ERC2 Formulation of water treatment and washing and cleaning products
Amounts used, Frequency and duration of use
Daily use at site ≤ 0.7 tonnes/day
Annual use at site ≤ 150 tonnes/year
Percentage of tonnage used at regional scale
100%
Conditions and measures related to municipal sewage treatment plant
Municipal STP Yes. [Effectiveness - Water: 87.34%]
Discharge rate of STP ≥ 2 X 103 m3/days
Application of the STP sludge on agricultural soil
Yes
Conditions and measures related to external treatment of waste for disposal
Particular considerations on the waste treatment operations: No (low risk) (ERC based assessment demonstrating control of risk with default conditions. Low risk assumed for waste life stage. Waste disposal according to national/local legislation is sufficient.)
Other given operational conditions affecting environmental exposure
Receiving surface water flow ≥ 1.8 X 104 m3/days
59/243
![Page 60: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/60.jpg)
Malic Acid
Revision: 8 Page: 58/241 Date: 27/10/2015
Contributing scenario controlling worker exposure (1)
PROC1 Use in closed process, no likelihood of exposure
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Use in closed systems. (minimal contact during routine operations)
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 80%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed One hand face only (240 cm2)
Contributing scenario controlling worker exposure (2)
PROC2 Use in closed, continuous process with occasional controlled exposure
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Closed continuous process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
60/243
![Page 61: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/61.jpg)
Malic Acid
Revision: 8 Page: 59/241 Date: 27/10/2015
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 80%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (3)
PROC4 Use in batch and other process (synthesis) where opportunity for exposure arises
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 80%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (4)
PROC8b Receiving and charging of the substance
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such 61/243
![Page 62: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/62.jpg)
Malic Acid
Revision: 8 Page: 60/241 Date: 27/10/2015
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (5)
PROC3 Mixing, dispersing, completion in closed batch process
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Closed batch process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use 62/243
![Page 63: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/63.jpg)
Malic Acid
Revision: 8 Page: 61/241 Date: 27/10/2015
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed One hand face only (240 cm2)
Contributing scenario controlling worker exposure (6)
PROC5 Mixing, dispersing and completion in open multistage batch process
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (7)
PROC8a Transfer in non-dedicated facilities
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%] 63/243
![Page 64: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/64.jpg)
Malic Acid
Revision: 8 Page: 62/241 Date: 27/10/2015
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (8)
PROC8b Transfer at dedicated facilities
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (9)
PROC9 Filling small containers in dedicated lines
Product (article) characteristic
Dustiness of material Low 64/243
![Page 65: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/65.jpg)
Malic Acid
Revision: 8 Page: 63/241 Date: 27/10/2015
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (10)
PROC8a Maintenance and cleaning operations
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
65/243
![Page 66: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/66.jpg)
Malic Acid
Revision: 8 Page: 64/241 Date: 27/10/2015
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (11)
PROC15 Use as laboratory reagent
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 80%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed One hand face only (240 cm2)
Contributing scenario controlling worker exposure (12)
PROC21 Low energy manipulation of substances bound in materials and/or articles
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
66/243
![Page 67: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/67.jpg)
Malic Acid
Revision: 8 Page: 65/241 Date: 27/10/2015
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands and forearms (1980 cm2)
Section 3: Exposure estimation and reference to its source
Contributing scenario controlling environmental exposure (1)
ERC2 Formulation of water treatment and washing and cleaning products
Release route Release rate Release estimation method
Water 14 kg/day ERC based
Air 17.5 kg/day ERC based
Soil 0.07 kg/day ERC based
Protection target Exposure estimation Risk characterisation ratio
Fresh water 0.089 mg/L 0.889
Sea water 0.009 mg/L 0.889
Sewage treatment plant 0.886 mg/L 0.295
Man via Environment - Inhalation 0.003 mg/m³ <0.01
Man via Environment - Oral 0.417 mg/kg bw/day 0.07
Contributing scenario controlling worker exposure (1)
PROC1 Use in closed process, no likelihood of exposure
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.01 mg/m³ <0.01
Inhalation, Systemic effects, Acute 0.04 mg/m³ <0.01 Inhalation, Local effects, Long Term
0.01 mg/m³ <0.01 67/243
![Page 68: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/68.jpg)
Malic Acid
Revision: 8 Page: 66/241 Date: 27/10/2015
Inhalation, Local effects, Acute 0.04 mg/m³ <0.01 Dermal, Systemic effects, Long Term
0.007 mg/kg bw/day <0.01
Dermal, Local effects, Long Term 0.002 mg/cm2 <0.01 Combined routes, Systemic effects, Long Term
- <0.01
Combined routes, Systemic effects, Acute
- <0.01
Contributing scenario controlling worker exposure (2)
PROC2 Use in closed, continuous process with occasional controlled exposure
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.01 mg/m³ <0.01
Inhalation, Systemic effects, Acute 0.04 mg/m³ <0.01 Inhalation, Local effects, Long Term
0.01 mg/m³ <0.01
Inhalation, Local effects, Acute 0.04 mg/m³ <0.01 Dermal, Systemic effects, Long Term
0.274 mg/kg bw/day 0.137
Dermal, Local effects, Long Term 0.04 mg/cm2 0.04 Combined routes, Systemic effects, Long Term
- 0.139
Combined routes, Systemic effects, Acute
- <0.01
Contributing scenario controlling worker exposure (3)
PROC4 Use in batch and other process (synthesis) where opportunity for exposure arises
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019 Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019 Dermal, Systemic effects, Long Term
1.372 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.2 mg/cm2 0.2 68/243
![Page 69: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/69.jpg)
Malic Acid
Revision: 8 Page: 67/241 Date: 27/10/2015
Combined routes, Systemic effects, Long Term
- 0.78
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (4)
PROC8b Receiving and charging of the substance
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ <0.01 Inhalation, Local effects, Long Term
0.1 mg/m³ <0.01
Inhalation, Local effects, Acute 0.4 mg/m³ <0.01 Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1 Combined routes, Systemic effects, Long Term
- 0.704
Combined routes, Systemic effects, Acute
- <0.01
Contributing scenario controlling worker exposure (5)
PROC3 Mixing, dispersing, completion in closed batch process
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ <0.01 Inhalation, Local effects, Long Term
0.1 mg/m³ <0.01
Inhalation, Local effects, Acute 0.4 mg/m³ <0.01 Dermal, Systemic effects, Long Term
0.069 mg/kg bw/day 0.034
Dermal, Local effects, Long Term 0.02 mg/cm2 0.02 Combined routes, Systemic effects, Long Term
- 0.053
Combined routes, Systemic effects, Acute
- <0.01 69/243
![Page 70: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/70.jpg)
Malic Acid
Revision: 8 Page: 68/241 Date: 27/10/2015
Contributing scenario controlling worker exposure (6)
PROC5 Mixing, dispersing and completion in open multistage batch process
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019 Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019 Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.2 mg/cm2 0.2 Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (7)
PROC8a Transfer in non-dedicated facilities
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019 Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019 Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1 Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
70/243
![Page 71: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/71.jpg)
Malic Acid
Revision: 8 Page: 69/241 Date: 27/10/2015
Contributing scenario controlling worker exposure (8)
PROC8b Transfer at dedicated facilities
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ <0.01 Inhalation, Local effects, Long Term
0.1 mg/m³ <0.01
Inhalation, Local effects, Acute 0.4 mg/m³ <0.01 Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1 Combined routes, Systemic effects, Long Term
- 0.704
Combined routes, Systemic effects, Acute
- <0.01
Contributing scenario controlling worker exposure (9)
PROC9 Filling small containers in dedicated lines
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ <0.01 Inhalation, Local effects, Long Term
0.1 mg/m³ <0.01
Inhalation, Local effects, Acute 0.4 mg/m³ <0.01 Dermal, Systemic effects, Long Term
0.686 mg/kg bw/day 0.343
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1 Combined routes, Systemic effects, Long Term
- 0.362
Combined routes, Systemic effects, Acute
- <0.01
71/243
![Page 72: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/72.jpg)
Malic Acid
Revision: 8 Page: 70/241 Date: 27/10/2015
Contributing scenario controlling worker exposure (10)
PROC8a Maintenance and cleaning operations
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019 Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019 Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1 Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (11)
PROC15 Use as laboratory reagent
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ <0.01 Inhalation, Local effects, Long Term
0.1 mg/m³ <0.01
Inhalation, Local effects, Acute 0.4 mg/m³ <0.01 Dermal, Systemic effects, Long Term
0.068 mg/kg bw/day 0.034
Dermal, Local effects, Long Term 0.02 mg/cm2 0.02 Combined routes, Systemic effects, Long Term
- 0.053
Combined routes, Systemic effects, Acute
- <0.01
72/243
![Page 73: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/73.jpg)
Malic Acid
Revision: 8 Page: 71/241 Date: 27/10/2015
Contributing scenario controlling worker exposure (12)
PROC21 Low energy manipulation of substances bound in materials and/or articles
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
1 mg/m³ 0.188
Inhalation, Systemic effects, Acute 4 mg/m³ 0.038 Inhalation, Local effects, Long Term
1 mg/m³ 0.031
Inhalation, Local effects, Acute 4 mg/m³ 0.038 Dermal, Systemic effects, Long Term
0.283 mg/kg bw/day 0.142
Dermal, Local effects, Long Term 0.01 mg/cm2 0.01 Combined routes, Systemic effects, Long Term
- 0.329
Combined routes, Systemic effects, Acute
- 0.038
Section 4: Guidance to DU to evaluate whether he works inside the boundaries set by the ES
No additional risk management measures, besides those that are mentioned above, are needed to guarantee safe use for workers.
Exposure Scenario 7: Use at industrial sites of water treatment washing and cleaning products
Section 1: Title of exposure scenario
Chemical product category [PC] PC2 Adsorbents PC20 Products such as ph-regulators, flocculants, precipitants, neutralization agents PC35 Washing and cleaning products (including solvent based products) PC36 Water softeners PC37 Water treatment chemicals PC40 Extraction agents
Sectors of use [SU] SU10 Formulation [mixing] of preparations and/or re-packaging (excluding alloys)
Contributing scenario controlling environmental exposure
ERC7 Use at industrial site
Contributing scenario controlling worker exposure
PROC2 Use/production of water treatment chemicals or washing and cleaning products in closed system with occasional controlled exposure PROC8b Raw material receipt and transfer PROC4 Use in batch and other process (synthesis) where opportunity for exposure arises PROC5 Preparation of water treatment chemicals or washing and cleaning products product 73/243
![Page 74: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/74.jpg)
Malic Acid
Revision: 8 Page: 72/241 Date: 27/10/2015
PROC14 Preparation production (general) PROC21 Low energy manipulation of substances bound in materials and/or articles PROC8a Batch loading of equipment (manual, non dedicated) PROC8a Manual cleaning and maintenance of equipment
Section 2: Operational conditions of use
Contributing scenario controlling environmental exposure (1)
ERC7 Use at industrial site
Amounts used, Frequency and duration of use
Daily use at site ≤ 0.3 tonnes/day
Annual use at site ≤ 75 tonnes/year
Percentage of tonnage used at regional scale
10%
Conditions and measures related to municipal sewage treatment plant
Municipal STP Yes. [Effectiveness - Water: 87.34%]
Discharge rate of STP ≥ 2 X 103 m3/days
Application of the STP sludge on agricultural soil
Yes
Conditions and measures related to external treatment of waste for disposal
Particular considerations on the waste treatment operations: No (low risk) (ERC based assessment demonstrating control of risk with default conditions. Low risk assumed for waste life stage. Waste disposal according to national/local legislation is sufficient.)
Other given operational conditions affecting environmental exposure
Receiving surface water flow ≥ 1.8 X 104 m3/days
Contributing scenario controlling worker exposure (1)
PROC2 Use/production of water treatment chemicals or washing and cleaning products in closed system with occasional controlled exposure
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Closed continuous process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced 74/243
![Page 75: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/75.jpg)
Malic Acid
Revision: 8 Page: 73/241 Date: 27/10/2015
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (2)
PROC8b Raw material receipt and transfer
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (3)
PROC4 Use in batch and other process (synthesis) where opportunity for exposure arises
Product (article) characteristic
Dustiness of material Low
Concentration of substance in >25% 75/243
![Page 76: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/76.jpg)
Malic Acid
Revision: 8 Page: 74/241 Date: 27/10/2015
mixture
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (4)
PROC5 Preparation of water treatment chemicals or washing and cleaning products product
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%] 76/243
![Page 77: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/77.jpg)
Malic Acid
Revision: 8 Page: 75/241 Date: 27/10/2015
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (5)
PROC14 Preparation production (general)
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (6)
PROC21 Low energy manipulation of substances bound in materials and/or articles
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use 77/243
![Page 78: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/78.jpg)
Malic Acid
Revision: 8 Page: 76/241 Date: 27/10/2015
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands and forearms (1980 cm2)
Contributing scenario controlling worker exposure (7)
PROC8a Batch loading of equipment (manual, non dedicated)
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Good general ventilation (3-5 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use 78/243
![Page 79: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/79.jpg)
Malic Acid
Revision: 8 Page: 77/241 Date: 27/10/2015
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (7)
PROC8a Batch loading of equipment (manual, non dedicated)
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Good general ventilation (3-5 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (8)
PROC8a Manual cleaning and maintenance of equipment
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
5-25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour) 79/243
![Page 80: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/80.jpg)
Malic Acid
Revision: 8 Page: 78/241 Date: 27/10/2015
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Section 3: Exposure estimation and reference to its source
Contributing scenario controlling environmental exposure (1)
ERC7 Use at industrial site
Release route Release rate Release estimation method
Water 6 kg/day Release factor
Air 0.3 kg/day Release factor
Soil 15 kg/day ERC based
Protection target Exposure estimation Risk characterisation ratio
Fresh water 0.038 mg/L 0.382
Sea water 0.004 mg/L 0.382
Sewage treatment plant 0.38 mg/L 0.127
Man via Environment - Inhalation 5.712 X 10-5 mg/m³ <0.01
Man via Environment - Oral 0.009 mg/kg bw/day <0.01
Contributing scenario controlling worker exposure (1)
PROC2 Use/production of water treatment chemicals or washing and cleaning products in closed system with occasional controlled exposure
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.01 mg/m³ <0.01
Inhalation, Systemic effects, Acute 0.04 mg/m³ <0.01 Inhalation, Local effects, Long Term
0.01 mg/m³ <0.01
Inhalation, Local effects, Acute 0.04 mg/m³ <0.01 80/243
![Page 81: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/81.jpg)
Malic Acid
Revision: 8 Page: 79/241 Date: 27/10/2015
Dermal, Systemic effects, Long Term
0.137 mg/kg bw/day 0.068
Dermal, Local effects, Long Term 0.02 mg/cm2 0.02 Combined routes, Systemic effects, Long Term
- 0.07
Combined routes, Systemic effects, Acute
- <0.01
Contributing scenario controlling worker exposure (2)
PROC8b Raw material receipt and transfer
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ <0.01 Inhalation, Local effects, Long Term
0.1 mg/m³ <0.01
Inhalation, Local effects, Acute 0.4 mg/m³ <0.01 Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1 Combined routes, Systemic effects, Long Term
- 0.704
Combined routes, Systemic effects, Acute
- <0.01
Contributing scenario controlling worker exposure (3)
PROC4 Use in batch and other process (synthesis) where opportunity for exposure arises
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019 Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019 Dermal, Systemic effects, Long Term
0.686 mg/kg bw/day 0.343
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1 Combined routes, Systemic effects, Long Term
- 0.437 81/243
![Page 82: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/82.jpg)
Malic Acid
Revision: 8 Page: 80/241 Date: 27/10/2015
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (4)
PROC5 Preparation of water treatment chemicals or washing and cleaning products product
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019 Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019 Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.2 mg/cm2 0.2 Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (5)
PROC14 Preparation production (general)
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ <0.01 Inhalation, Local effects, Long Term
0.1 mg/m³ <0.01
Inhalation, Local effects, Acute 0.4 mg/m³ <0.01 Dermal, Systemic effects, Long Term
0.343 mg/kg bw/day 0.172
Dermal, Local effects, Long Term 0.05 mg/cm2 0.05 Combined routes, Systemic effects, Long Term
- 0.19
Combined routes, Systemic effects, Acute
- <0.01
Contributing scenario controlling worker exposure (6)
PROC21 Low energy manipulation of substances bound in materials and/or articles
Method: TRA Worker v3 82/243
![Page 83: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/83.jpg)
Malic Acid
Revision: 8 Page: 81/241 Date: 27/10/2015
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
1 mg/m³ 0.188
Inhalation, Systemic effects, Acute 4 mg/m³ 0.038 Inhalation, Local effects, Long Term
1 mg/m³ 0.031
Inhalation, Local effects, Acute 4 mg/m³ 0.038 Dermal, Systemic effects, Long Term
0.283 mg/kg bw/day 0.142
Dermal, Local effects, Long Term 0.01 mg/cm2 0.01 Combined routes, Systemic effects, Long Term
- 0.329
Combined routes, Systemic effects, Acute
- 0.038
Contributing scenario controlling worker exposure (7)
PROC8a Batch loading of equipment (manual, non dedicated)
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.35 mg/m³ 0.066
Inhalation, Systemic effects, Acute 1.4 mg/m³ 0.013 Inhalation, Local effects, Long Term
0.35 mg/m³ 0.011
Inhalation, Local effects, Acute 1.4 mg/m³ 0.013 Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1 Combined routes, Systemic effects, Long Term
- 0.751
Combined routes, Systemic effects, Acute
- 0.013
Contributing scenario controlling worker exposure (8)
PROC8a Manual cleaning and maintenance of equipment
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.3 mg/m³ 0.056
Inhalation, Systemic effects, Acute 1.2 mg/m³ 0.012 83/243
![Page 84: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/84.jpg)
Malic Acid
Revision: 8 Page: 82/241 Date: 27/10/2015
Inhalation, Local effects, Long Term
0.3 mg/m³ <0.01
Inhalation, Local effects, Acute 1.2 mg/m³ 0.012
Dermal, Systemic effects, Long Term
0.823 mg/kg bw/day 0.411
Dermal, Local effects, Long Term 0.06 mg/cm2 0.06
Combined routes, Systemic effects, Long Term
- 0.468
Combined routes, Systemic effects, Acute
- 0.012
Section 4: Guidance to DU to evaluate whether he works inside the boundaries set by the ES
No additional risk management measures, besides those that are mentioned above, are needed to guarantee safe use for workers.
Exposure Scenario 8: Professional use in water treatment and cleaning products
Section 1: Title of exposure scenario
Chemical product category [PC] PC2 Adsorbents PC20 Products such as ph-regulators, flocculants, precipitants, neutralization agents PC35 Washing and cleaning products (including solvent based products) PC36 Water softeners PC37 Water treatment chemicals PC40 Extraction agents
Contributing scenario controlling environmental exposure
ERC8a Professional use in water treatment and cleaning products
Contributing scenario controlling worker exposure
PROC8b Raw material receipt and transfer PROC5 Batch or other process with opportunity for exposure PROC21 Low energy manipulation of substances bound in materials and/or articles PROC8a Transfer in non-dedicated facilities
Section 2: Operational conditions of use
Contributing scenario controlling environmental exposure (1)
ERC8a Professional use in water treatment and cleaning products
Amounts used, Frequency and duration of use
Daily wide dispersive use ≤ 5.5 X 10-6 tonnes/day
Percentage of tonnage used at regional scale
10%
Conditions and measures related to municipal sewage treatment plant
Municipal STP Yes. [Effectiveness - Water: 87.34%]
Discharge rate of STP ≥ 2 X 103 m3/days
84/243
![Page 85: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/85.jpg)
Malic Acid
Revision: 8 Page: 83/241 Date: 27/10/2015
Application of the STP sludge on agricultural soil
Yes
Conditions and measures related to external treatment of waste for disposal
Particular considerations on the waste treatment operations: No (low risk) (ERC based assessment demonstrating control of risk with default conditions. Low risk assumed for waste life stage. Waste disposal according to national/local legislation is sufficient.)
Other given operational conditions affecting environmental exposure
Receiving surface water flow ≥ 1.8 X 104 m3/days
Contributing scenario controlling worker exposure (1)
PROC8b Raw material receipt and transfer
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Basic
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (2)
PROC5 Batch or other process with opportunity for exposure
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
85/243
![Page 86: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/86.jpg)
Malic Acid
Revision: 8 Page: 84/241 Date: 27/10/2015
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Basic
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (3)
PROC21 Low energy manipulation of substances bound in materials and/or articles
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Basic
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield 86/243
![Page 87: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/87.jpg)
Malic Acid
Revision: 8 Page: 85/241 Date: 27/10/2015
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands and forearms (1980 cm2)
Contributing scenario controlling worker exposure (4) PROC8a Transfer in non-dedicated facilities
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Basic
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Section 3: Exposure estimation and reference to its source
Contributing scenario controlling environmental exposure (1)
ERC8a Professional use in water treatment and cleaning products
Release route Release rate Release estimation method
Water 0.006 kg/day ERC based
Air 0.006 kg/day ERC based
Soil 0 kg/day ERC based
Protection target Exposure estimation Risk characterisation ratio
Fresh water 2.988 X 10-4 mg/L <0.01 87/243
![Page 88: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/88.jpg)
Malic Acid
Revision: 8 Page: 86/241 Date: 27/10/2015
Sea water 2.869 X 10-5 mg/L <0.01 Sewage treatment plant 3.481 X 10-4 mg/L <0.01 Man via Environment - Inhalation 2.912 X 10-11 mg/m³ <0.01 Man via Environment - Oral 7.299 X 10-5 mg/kg bw/day <0.01 Contributing scenario controlling worker exposure (1)
PROC8b Raw material receipt and transfer
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (2)
PROC5 Batch or other process with opportunity for exposure
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
1 mg/m³ 0.188
Inhalation, Systemic effects, Acute 4 mg/m³ 0.038
Inhalation, Local effects, Long Term
1 mg/m³ 0.031
Inhalation, Local effects, Acute 4 mg/m³ 0.038
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.2 mg/cm2 0.2
Combined routes, Systemic effects, Long Term
- 0.873
Combined routes, Systemic effects, Acute
- 0.038 88/243
![Page 89: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/89.jpg)
Malic Acid
Revision: 8 Page: 87/241 Date: 27/10/2015
Contributing scenario controlling worker exposure (3)
PROC21 Low energy manipulation of substances bound in materials and/or articles
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
3 mg/m³ 0.563
Inhalation, Systemic effects, Acute 12 mg/m³ 0.115
Inhalation, Local effects, Long Term
3 mg/m³ 0.094
Inhalation, Local effects, Acute 12 mg/m³ 0.115
Dermal, Systemic effects, Long Term
0.283 mg/kg bw/day 0.142
Dermal, Local effects, Long Term 0.01 mg/cm2 0.01
Combined routes, Systemic effects, Long Term
- 0.704
Combined routes, Systemic effects, Acute
- 0.115
Contributing scenario controlling worker exposure (4)
PROC8a Transfer in non-dedicated facilities
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
Section 4: Guidance to DU to evaluate whether he works inside the boundaries set by the ES
No additional risk management measures, besides those that are mentioned above, are needed to guarantee safe use for workers.
89/243
![Page 90: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/90.jpg)
Malic Acid
Revision: 8 Page: 88/241 Date: 27/10/2015
Exposure Scenario 9: Consumer water treatment and cleaning product use
Section 1: Title of exposure scenario
Chemical product category [PC] PC2 Adsorbents PC20 Products such as ph-regulators, flocculants, precipitants, neutralization agents PC35 Washing and cleaning products (including solvent based products) PC36 Water softeners PC37 Water treatment chemicals PC40 Extraction agents
Contributing scenario controlling environmental exposure
ERC8a Consumer water treatment and cleaning product use
Contributing scenario controlling consumer exposure
PC36 Water softeners PC35 Washing and cleaning products PC37 Water treatment chemicals PC2 Adsorbents
Subsequent service life exposure scenario(s)
ES 25 Service life (professional worker); Service life articles used by workers; SU 5; SU 6b; SU 11; SU 12; SU 13; SU 16; SU 17; SU 18; SU 19; SU 0
ES 26 Service life (consumers); Service life articles used by consumers
Section 2: Operational conditions of use
Contributing scenario controlling environmental exposure (1)
ERC8a Consumer water treatment and cleaning product use
Amounts used, Frequency and duration of use
Daily wide dispersive use ≤ 3.575 X 10-5 tonnes/day
Percentage of tonnage used at regional scale
10%
Conditions and measures related to municipal sewage treatment plant
Municipal STP Yes. [Effectiveness - Water: 87.34%]
Discharge rate of STP ≥ 2 X 103 m3/days
Application of the STP sludge on agricultural soil
Yes
Conditions and measures related to external treatment of waste for disposal
Particular considerations on the waste treatment operations: No (low risk) (ERC based assessment demonstrating control of risk with default conditions. Low risk assumed for waste life stage. Waste disposal according to national/local legislation is sufficient.)
Other given operational conditions affecting environmental exposure
Receiving surface water flow ≥ 1.8 X 104 m3/days
Contributing scenario controlling consumer exposure (1)
PC36 Water softeners
Product (article) characteristic
Product/ Article subcategory No value
Contributing scenario controlling consumer exposure (2) 90/243
![Page 91: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/91.jpg)
Malic Acid
Revision: 8 Page: 89/241 Date: 27/10/2015
PC35 Washing and cleaning products
Product (article) characteristic
Product/ Article subcategory Cleaners, liquids (all purposes cleaners, sanitary products, floor cleaners, glass cleaners, carpet cleaners, metal cleaners)
Concentration of substance in mixture
0.8 g/g “Concentration of the substance in the product has been set to up to 100% (substance as such) for assessment purposes”
Oral contact foreseen No.
Amounts used, Frequency and duration of use
Amount of product used per application
500 g/event
Exposure time 0.33 hour(s)
Frequency of use 1 event/day
Other conditions affecting consumers exposure
Body parts potentially exposed Fingertips
Dermal transfer factor 1
Contributing scenario controlling consumer exposure (3)
PC37 Water treatment chemicals
Product (article) characteristic
Product/ Article subcategory No value
Contributing scenario controlling consumer exposure (4)
PC2 Adsorbents
Product (article) characteristic
Product/ Article subcategory No value
Section 3: Exposure estimation and reference to its source
Contributing scenario controlling environmental exposure (1)
ERC8a Consumer water treatment and cleaning product use
Release route Release rate Release estimation method
Water 0.036 kg/day ERC based
Air 0.036 kg/day ERC based
Soil 0 kg/day ERC based
Protection target Exposure estimation Risk characterisation ratio
Fresh water 4.86 X 10-4 mg/L <0.01 Sea water 4.746 X 10-5 mg/L <0.01 Sewage treatment plant 0.002 mg/L <0.01 Man via Environment - Inhalation 3.011 X 10-11 mg/m³ <0.01 Man via Environment - Oral 7.624 X 10-5 mg/kg bw/day <0.01
91/243
![Page 92: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/92.jpg)
Malic Acid
Revision: 8 Page: 90/241 Date: 27/10/2015
Contributing scenario controlling consumer exposure (1)
PC36 Water softeners
Not available
Contributing scenario controlling consumer exposure (2)
PC35 Washing and cleaning products
Method: TRA Consumer v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.022 mg/m³ 0.014
Inhalation, Local effects, Long Term
0.022 mg/m³ 0.014
Dermal, Systemic effects, Long Term
4.76 mg/kg bw/day 0.793
Oral, Systemic effects, Long Term
0 mg/kg bw/day < 0.01
Combined routes, Systemic effects, Long Term
- 0.807
Contributing scenario controlling consumer exposure (3)
PC37 Water treatment chemicals
Not available
Contributing scenario controlling consumer exposure (4) PC2 Adsorbents
Not available
Section 4: Guidance to DU to evaluate whether he works inside the boundaries set by the ES
No additional risk management measures, besides those that are mentioned above, are needed to guarantee safe use for workers.
Exposure Scenario 10: Formulation - SpERC: Cosmetics Europe / AISE 2.3b.V2 - (medium scale)
Section 1: Title of exposure scenario 92/243
![Page 93: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/93.jpg)
Malic Acid
Revision: 8 Page: 91/241 Date: 27/10/2015
Chemical product category [PC] PC29 Pharmaceuticals PC39 Cosmetics, personal care products
Contributing scenario controlling environmental exposure
ERC2 Formulation of preparations
Contributing scenario controlling worker exposure
PROC1 Use in closed process, no likelihood of exposure PROC2 Use in closed, continuous process with occasional controlled exposure PROC4 Use in batch and other process (synthesis) where opportunity for exposure arises PROC8b Receiving and charging of the substance PROC3 Mixing, dispersing, completion in closed batch process PROC5 Mixing, dispersing and completion in open multistage batch process PROC8a Transfer in non-dedicated facilities PROC8b Transfer at dedicated facilities PROC9 Filling small containers in dedicated lines PROC8a Maintenance and cleaning operations PROC15 Use as laboratory reagent
Section 2: Operational conditions of use
Contributing scenario controlling environmental exposure (1)
ERC2 Formulation of preparations
Amounts used, Frequency and duration of use
Daily use at site ≤ 0.5 tonnes/day
Annual use at site ≤ 150 tonnes/year
Percentage of tonnage used at regional scale
100%
Conditions and measures related to municipal sewage treatment plant
Municipal STP Yes. [Effectiveness - Water: 87.34%]
Discharge rate of STP ≥ 2 X 103 m3/days
Application of the STP sludge on agricultural soil
Yes
Conditions and measures related to external treatment of waste for disposal
Particular considerations on the waste treatment operations: No (low risk) (ERC based assessment demonstrating control of risk with default conditions. Low risk assumed for waste life stage. Waste disposal according to national/local legislation is sufficient.)
Other given operational conditions affecting environmental exposure
Receiving surface water flow ≥ 1.8 X 104 m3/days
Contributing scenario controlling worker exposure (1)
PROC1 Use in closed process, no likelihood of exposure
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
93/243
![Page 94: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/94.jpg)
Malic Acid
Revision: 8 Page: 92/241 Date: 27/10/2015
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Use in closed systems. (minimal contact during routine operations)
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 80%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed One hand face only (240 cm2)
Contributing scenario controlling worker exposure (2)
PROC2 Use in closed, continuous process with occasional controlled exposure
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Closed continuous process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 80%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use 94/243
![Page 95: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/95.jpg)
Malic Acid
Revision: 8 Page: 93/241 Date: 27/10/2015
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (3)
PROC4 Use in batch and other process (synthesis) where opportunity for exposure arises
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 80%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (4)
PROC8b Receiving and charging of the substance
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Advanced 95/243
![Page 96: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/96.jpg)
Malic Acid
Revision: 8 Page: 94/241 Date: 27/10/2015
Management System
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (5)
PROC3 Mixing, dispersing, completion in closed batch process
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Closed batch process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed One hand face only (240 cm2)
Contributing scenario controlling worker exposure (6)
PROC5 Mixing, dispersing and completion in open multistage batch process
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such 96/243
![Page 97: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/97.jpg)
Malic Acid
Revision: 8 Page: 95/241 Date: 27/10/2015
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (7)
PROC8a Transfer in non-dedicated facilities
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use 97/243
![Page 98: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/98.jpg)
Malic Acid
Revision: 8 Page: 96/241 Date: 27/10/2015
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (8)
PROC8b Transfer at dedicated facilities
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Good general ventilation (3-5 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 95%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (9)
PROC9 Filling small containers in dedicated lines
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
98/243
![Page 99: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/99.jpg)
Malic Acid
Revision: 8 Page: 97/241 Date: 27/10/2015
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (10)
PROC8a Maintenance and cleaning operations
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (11)
PROC15 Use as laboratory reagent
Product (article) characteristic
Dustiness of material Low 99/243
![Page 100: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/100.jpg)
Malic Acid
Revision: 8 Page: 98/241 Date: 27/10/2015
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 80%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed One hand face only (240 cm2)
Section 3: Exposure estimation and reference to its source
Contributing scenario controlling environmental exposure (1)
ERC2 Formulation of preparations
Release route Release rate Release estimation method
Water 0.5 kg/day SpERC based
Air 0 kg/day SpERC based
Soil 0 kg/day SpERC based
Protection target Exposure estimation Risk characterisation ratio
Fresh water 0.003 mg/L 0.034
Sea water 3.416 X 10-4 mg/L 0.034
Sewage treatment plant 0.032 mg/L 0.011
Man via Environment - Inhalation 2.914 X 10-11 mg/m³ < 0.01
Man via Environment - Oral 1.049 X 10-4 mg/kg bw/day < 0.01
Contributing scenario controlling worker exposure (1)
PROC1 Use in closed process, no likelihood of exposure
Method: TRA Worker v3
100/243
![Page 101: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/101.jpg)
Malic Acid
Revision: 8 Page: 99/241 Date: 27/10/2015
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.01 mg/m³ <0.01
Inhalation, Systemic effects, Acute 0.04 mg/m³ <0.01 Inhalation, Local effects, Long Term
0.01 mg/m³ <0.01
Inhalation, Local effects, Acute 0.04 mg/m³ <0.01 Dermal, Systemic effects, Long Term
0.007 mg/kg bw/day <0.01
Dermal, Local effects, Long Term 0.002 mg/cm2 <0.01 Combined routes, Systemic effects, Long Term
- <0.01
Combined routes, Systemic effects, Acute
- <0.01
Contributing scenario controlling worker exposure (2)
PROC2 Use in closed, continuous process with occasional controlled exposure
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.01 mg/m³ <0.01
Inhalation, Systemic effects, Acute 0.04 mg/m³ <0.01 Inhalation, Local effects, Long Term
0.01 mg/m³ <0.01
Inhalation, Local effects, Acute 0.04 mg/m³ <0.01 Dermal, Systemic effects, Long Term
0.274 mg/kg bw/day 0.137
Dermal, Local effects, Long Term 0.04 mg/cm2 0.04 Combined routes, Systemic effects, Long Term
- 0.139
Combined routes, Systemic effects, Acute
- <0.01
Contributing scenario controlling worker exposure (3)
PROC4 Use in batch and other process (synthesis) where opportunity for exposure arises
Method: TRA Worker v3
101/243
![Page 102: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/102.jpg)
Malic Acid
Revision: 8 Page: 100/241 Date: 27/10/2015
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.372 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.2 mg/cm2 0.2
Combined routes, Systemic effects, Long Term
- 0.78
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (4)
PROC8b Receiving and charging of the substance
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.1 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.4 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.704
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (5)
PROC3 Mixing, dispersing, completion in closed batch process
Method: TRA Worker v3
102/243
![Page 103: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/103.jpg)
Malic Acid
Revision: 8 Page: 101/241 Date: 27/10/2015
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.1 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.4 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
0.069 mg/kg bw/day 0.034
Dermal, Local effects, Long Term 0.02 mg/cm2 0.02
Combined routes, Systemic effects, Long Term
- 0.053
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (6)
PROC5 Mixing, dispersing and completion in open multistage batch process
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.2 mg/cm2 0.2
Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (7)
PROC8a Transfer in non-dedicated facilities
Method: TRA Worker v3
103/243
![Page 104: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/104.jpg)
Malic Acid
Revision: 8 Page: 102/241 Date: 27/10/2015
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (8)
PROC8b Transfer at dedicated facilities
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.07 mg/m³ 0.013
Inhalation, Systemic effects, Acute 0.28 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.07 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.28 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
0.686 mg/kg bw/day 0.343
Dermal, Local effects, Long Term 0.05 mg/cm2 0.05
Combined routes, Systemic effects, Long Term
- 0.356
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (9)
PROC9 Filling small containers in dedicated lines
Method: TRA Worker v3
104/243
![Page 105: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/105.jpg)
Malic Acid
Revision: 8 Page: 103/241 Date: 27/10/2015
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.1 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.4 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
0.686 mg/kg bw/day 0.343
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.362
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (10)
PROC8a Maintenance and cleaning operations
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (11)
PROC15 Use as laboratory reagent
Method: TRA Worker v3
105/243
![Page 106: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/106.jpg)
Malic Acid
Revision: 8 Page: 104/241 Date: 27/10/2015
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.1 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.4 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
0.068 mg/kg bw/day 0.034
Dermal, Local effects, Long Term 0.02 mg/cm2 0.02
Combined routes, Systemic effects, Long Term
- 0.053
Combined routes, Systemic effects, Acute
- < 0.01
Section 4: Guidance to DU to evaluate whether he works inside the boundaries set by the ES
No additional risk management measures, besides those that are mentioned above, are needed to guarantee safe use for workers. Exposure Scenario 11: Formulation - SpERC: Cosmetics Europe / AISE 2.1b.V2 - (medium scale)
Section 1: Title of exposure scenario
Chemical product category [PC] PC29 Pharmaceuticals PC39 Cosmetics, personal care products
Contributing scenario controlling environmental exposure
ERC2 Formulation of preparations
Contributing scenario controlling worker exposure
PROC1 Use in closed process, no likelihood of exposure PROC2 Use in closed, continuous process with occasional controlled exposure PROC4 Use in batch and other process (synthesis) where opportunity for exposure arises PROC8b Receiving and charging of the substance PROC3 Mixing, dispersing, completion in closed batch process PROC5 Mixing, dispersing and completion in open multistage batch process PROC8a Transfer in non-dedicated facilities PROC8b Transfer at dedicated facilities PROC9 Filling small containers in dedicated lines PROC8a Maintenance and cleaning operations PROC15 Use as laboratory reagent
Section 2: Operational conditions of use
Contributing scenario controlling environmental exposure (1)
ERC2 Formulation of preparations
106/243
![Page 107: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/107.jpg)
Malic Acid
Revision: 8 Page: 105/241 Date: 27/10/2015
Amounts used, Frequency and duration of use
Daily use at site ≤ 0.2 tonnes/day
Annual use at site ≤ 50 tonnes/year
Percentage of tonnage used at regional scale
100%
Conditions and measures related to municipal sewage treatment plant
Municipal STP Yes. [Effectiveness - Water: 87.34%]
Discharge rate of STP ≥ 2 X 103 m3/days
Application of the STP sludge on agricultural soil
Yes
Conditions and measures related to external treatment of waste for disposal
Particular considerations on the waste treatment operations: No (low risk) (ERC based assessment demonstrating control of risk with default conditions. Low risk assumed for waste life stage. Waste disposal according to national/local legislation is sufficient.)
Other given operational conditions affecting environmental exposure
Receiving surface water flow ≥ 1.8 X 104 m3/days
Contributing scenario controlling worker exposure (1)
PROC1 Use in closed process, no likelihood of exposure
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Use in closed systems. (minimal contact during routine operations)
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 80%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use 107/243
![Page 108: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/108.jpg)
Malic Acid
Revision: 8 Page: 106/241 Date: 27/10/2015
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed One hand face only (240 cm2)
Contributing scenario controlling worker exposure (2)
PROC2 Use in closed, continuous process with occasional controlled exposure
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Closed continuous process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 80%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (3)
PROC4 Use in batch and other process (synthesis) where opportunity for exposure arises
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
108/243
![Page 109: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/109.jpg)
Malic Acid
Revision: 8 Page: 107/241 Date: 27/10/2015
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 80%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (4)
PROC8b Receiving and charging of the substance
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (5)
PROC3 Mixing, dispersing, completion in closed batch process
Product (article) characteristic
Dustiness of material Low 109/243
![Page 110: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/110.jpg)
Malic Acid
Revision: 8 Page: 108/241 Date: 27/10/2015
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Closed batch process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed One hand face only (240 cm2)
Contributing scenario controlling worker exposure (6)
PROC5 Mixing, dispersing and completion in open multistage batch process
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
110/243
![Page 111: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/111.jpg)
Malic Acid
Revision: 8 Page: 109/241 Date: 27/10/2015
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (7)
PROC8a Transfer in non-dedicated facilities
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (8)
PROC8b Transfer at dedicated facilities
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Good general ventilation (3-5 air changes per hour) 111/243
![Page 112: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/112.jpg)
Malic Acid
Revision: 8 Page: 110/241 Date: 27/10/2015
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 95%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (9)
PROC9 Filling small containers in dedicated lines
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands face (480 cm2)
112/243
![Page 113: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/113.jpg)
Malic Acid
Revision: 8 Page: 111/241 Date: 27/10/2015
Contributing scenario controlling worker exposure (10)
PROC8a Maintenance and cleaning operations
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (11)
PROC15 Use as laboratory reagent
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
113/243
![Page 114: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/114.jpg)
Malic Acid
Revision: 8 Page: 112/241 Date: 27/10/2015
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 80%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed One hand face only (240 cm2)
Section 3: Exposure estimation and reference to its source
Contributing scenario controlling environmental exposure (1)
ERC2 Formulation of preparations
Release route Release rate Release estimation method
Water 0.4 kg/day SpERC based
Air 0 kg/day SpERC based
Soil 0 kg/day SpERC based
Protection target Exposure estimation Risk characterisation ratio
Fresh water 0.003 mg/L 0.028
Sea water 2.783 X 10-4 mg/L 0.028
Sewage treatment plant 0.025 mg/L < 0.01
Man via Environment - Inhalation 2.913 X 10-11 mg/m³ < 0.01
Man via Environment - Oral 8.144 X 10-5 mg/kg bw/day < 0.01
Contributing scenario controlling worker exposure (1)
PROC1 Use in closed process, no likelihood of exposure
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.01 mg/m³ <0.01
Inhalation, Systemic effects, Acute 0.04 mg/m³ <0.01 Inhalation, Local effects, Long Term
0.01 mg/m³ <0.01
Inhalation, Local effects, Acute 0.04 mg/m³ <0.01 Dermal, Systemic effects, Long Term
0.007 mg/kg bw/day <0.01
Dermal, Local effects, Long Term 0.002 mg/cm2 <0.01 Combined routes, Systemic effects, Long Term
- <0.01 114/243
![Page 115: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/115.jpg)
Malic Acid
Revision: 8 Page: 113/241 Date: 27/10/2015
Combined routes, Systemic effects, Acute
- <0.01
Contributing scenario controlling worker exposure (2)
PROC2 Use in closed, continuous process with occasional controlled exposure
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.01 mg/m³ <0.01
Inhalation, Systemic effects, Acute 0.04 mg/m³ <0.01 Inhalation, Local effects, Long Term
0.01 mg/m³ <0.01
Inhalation, Local effects, Acute 0.04 mg/m³ <0.01 Dermal, Systemic effects, Long Term
0.274 mg/kg bw/day 0.137
Dermal, Local effects, Long Term 0.04 mg/cm2 0.04 Combined routes, Systemic effects, Long Term
- 0.139
Combined routes, Systemic effects, Acute
- <0.01
Contributing scenario controlling worker exposure (3)
PROC4 Use in batch and other process (synthesis) where opportunity for exposure arises
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.372 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.2 mg/cm2 0.2
Combined routes, Systemic effects, Long Term
- 0.78
Combined routes, Systemic effects, Acute
- 0.019
115/243
![Page 116: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/116.jpg)
Malic Acid
Revision: 8 Page: 114/241 Date: 27/10/2015
Contributing scenario controlling worker exposure (4)
PROC8b Receiving and charging of the substance
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.1 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.4 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.704
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (5)
PROC3 Mixing, dispersing, completion in closed batch process
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.1 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.4 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
0.069 mg/kg bw/day 0.034
Dermal, Local effects, Long Term 0.02 mg/cm2 0.02
Combined routes, Systemic effects, Long Term
- 0.053
Combined routes, Systemic effects, Acute
- < 0.01
116/243
![Page 117: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/117.jpg)
Malic Acid
Revision: 8 Page: 115/241 Date: 27/10/2015
Contributing scenario controlling worker exposure (6)
PROC5 Mixing, dispersing and completion in open multistage batch process
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.2 mg/cm2 0.2
Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (7)
PROC8a Transfer in non-dedicated facilities
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
117/243
![Page 118: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/118.jpg)
Malic Acid
Revision: 8 Page: 116/241 Date: 27/10/2015
Contributing scenario controlling worker exposure (8)
PROC8b Transfer at dedicated facilities
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.07 mg/m³ 0.013
Inhalation, Systemic effects, Acute 0.28 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.07 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.28 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
0.686 mg/kg bw/day 0.343
Dermal, Local effects, Long Term 0.05 mg/cm2 0.05
Combined routes, Systemic effects, Long Term
- 0.356
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (9)
PROC9 Filling small containers in dedicated lines
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.1 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.4 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
0.686 mg/kg bw/day 0.343
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.362
Combined routes, Systemic effects, Acute
- < 0.01
118/243
![Page 119: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/119.jpg)
Malic Acid
Revision: 8 Page: 117/241 Date: 27/10/2015
Contributing scenario controlling worker exposure (10)
PROC8a Maintenance and cleaning operations
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (11)
PROC15 Use as laboratory reagent
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.1 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.4 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
0.068 mg/kg bw/day 0.034
Dermal, Local effects, Long Term 0.02 mg/cm2 0.02
Combined routes, Systemic effects, Long Term
- 0.053
Combined routes, Systemic effects, Acute
- < 0.01
Section 4: Guidance to DU to evaluate whether he works inside the boundaries set by the ES
No additional risk management measures, besides those that are mentioned above, are needed to guarantee safe use for workers.
119/243
![Page 120: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/120.jpg)
Malic Acid
Revision: 8 Page: 118/241 Date: 27/10/2015
Exposure Scenario 12: Consumer cosmetics, pharmaceuticals and personal care products
Section 1: Title of exposure scenario
Chemical product category [PC] PC29 Pharmaceuticals PC39 Cosmetics, personal care products
Contributing scenario controlling environmental exposure
ERC8e, ERC8b Consumer use
Contributing scenario controlling consumer exposure
PC39 Cosmetics, personal care products PC29 Pharmaceuticals
Subsequent service life exposure scenario(s)
ES 26 Service life (consumers); Service life articles used by consumers
Section 2: Operational conditions of use
Contributing scenario controlling environmental exposure (1)
ERC8e Consumer use
Amounts used, Frequency and duration of use
Daily wide dispersive use ≤ 8.25 X 10-5 tonnes/day
Percentage of tonnage used at regional scale
10%
Conditions and measures related to municipal sewage treatment plant
Municipal STP Yes. [Effectiveness - Water: 87.34%]
Discharge rate of STP ≥ 2 X 103 m3/days
Application of the STP sludge on agricultural soil
Yes
Conditions and measures related to external treatment of waste for disposal
Particular considerations on the waste treatment operations: No (low risk) (ERC based assessment demonstrating control of risk with default conditions. Low risk assumed for waste life stage. Waste disposal according to national/local legislation is sufficient.)
Other given operational conditions affecting environmental exposure
Receiving surface water flow ≥ 1.8 X 104 m3/days
Contributing scenario controlling consumer exposure (1)
PC39 Cosmetics, personal care products
Product (article) characteristic
Product/ Article subcategory No value
Contributing scenario controlling consumer exposure (2)
PC29 Pharmaceuticals
Product (article) characteristic
Product/ Article subcategory No value
Section 3: Exposure estimation and reference to its source
Contributing scenario controlling environmental exposure (1)
ERC8e Consumer use
120/243
![Page 121: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/121.jpg)
Malic Acid
Revision: 8 Page: 119/241 Date: 27/10/2015
Release route Release rate Release estimation method
Water 0.002 kg/day ERC based
Air 8.25 X 10-5 kg/day ERC based
Soil 8.25 X 10-4 kg/day ERC based
Protection target Exposure estimation Risk characterisation ratio
Fresh water 2.744 X 10-4 mg/L <0.01 Sea water 2.625 X 10-5 mg/L <0.01 Sewage treatment plant 1.044 X 10-4 mg/L <0.01 Man via Environment - Inhalation 2.912 X 10-11 mg/m³ <0.01 Man via Environment - Oral 7.289 X 10-5 mg/kg bw/day <0.01 Contributing scenario controlling consumer exposure (1)
PC39 Cosmetics, personal care products
Not available
Contributing scenario controlling consumer exposure (2)
PC29 Pharmaceuticals
Not available
Section 4: Guidance to DU to evaluate whether he works inside the boundaries set by the ES
No additional risk management measures, besides those that are mentioned above, are needed to guarantee safe use for workers.
Exposure Scenario 13: Formulation - dyestuffs and textiles use
Section 1: Title of exposure scenario
Chemical product category [PC] PC23 Leather tanning, dye, finishing, impregnation and care products PC26 Paper and board dye, finishing and impregnation products: including bleaches and other processing aids PC34 Textile dyes, finishing and impregnating products; including bleaches and other processing aids
Contributing scenario controlling environmental exposure
ERC2 Formulation of preparations
Contributing scenario controlling worker exposure
PROC1 Use in closed process, no likelihood of exposure PROC2 Use in closed, continuous process with occasional controlled exposure PROC4 Use in batch and other process (synthesis) where opportunity for exposure arises PROC8b Receiving and charging of the substance PROC3 Mixing, dispersing, completion in closed batch process PROC5 Mixing, dispersing and completion in open multistage batch process PROC8a Transfer in non-dedicated facilities PROC8b Transfer at dedicated facilities PROC9 Filling small containers in dedicated lines PROC8a Maintenance and cleaning operations PROC15 Use as laboratory reagent 121/243
![Page 122: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/122.jpg)
Malic Acid
Revision: 8 Page: 120/241 Date: 27/10/2015
Section 2: Operational conditions of use
Contributing scenario controlling environmental exposure (1)
ERC2 Formulation of preparations
Amounts used, Frequency and duration of use
Daily use at site ≤ 0.7 tonnes/day
Annual use at site ≤ 150 tonnes/year
Percentage of tonnage used at regional scale
100%
Conditions and measures related to municipal sewage treatment plant
Municipal STP Yes. [Effectiveness - Water: 87.34%]
Discharge rate of STP ≥ 2 X 103 m3/days
Application of the STP sludge on agricultural soil
Yes
Conditions and measures related to external treatment of waste for disposal
Particular considerations on the waste treatment operations: No (low risk) (ERC based assessment demonstrating control of risk with default conditions. Low risk assumed for waste life stage. Waste disposal according to national/local legislation is sufficient.)
Other given operational conditions affecting environmental exposure
Receiving surface water flow ≥ 1.8 X 104 m3/days
Contributing scenario controlling worker exposure (1)
PROC1 Use in closed process, no likelihood of exposure
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Use in closed systems. (minimal contact during routine operations)
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 80%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield 122/243
![Page 123: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/123.jpg)
Malic Acid
Revision: 8 Page: 121/241 Date: 27/10/2015
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed One hand face only (240 cm2)
Contributing scenario controlling worker exposure (2)
PROC2 Use in closed, continuous process with occasional controlled exposure
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Closed continuous process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 80%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (3)
PROC4 Use in batch and other process (synthesis) where opportunity for exposure arises
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Semi-closed process with occasional controlled exposure 123/243
![Page 124: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/124.jpg)
Malic Acid
Revision: 8 Page: 122/241 Date: 27/10/2015
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 80%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (4)
PROC8b Receiving and charging of the substance
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (5)
PROC3 Mixing, dispersing, completion in closed batch process
Product (article) characteristic
Dustiness of material Low 124/243
![Page 125: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/125.jpg)
Malic Acid
Revision: 8 Page: 123/241 Date: 27/10/2015
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Closed batch process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed One hand face only (240 cm2)
Contributing scenario controlling worker exposure (6)
PROC5 Mixing, dispersing and completion in open multistage batch process
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
125/243
![Page 126: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/126.jpg)
Malic Acid
Revision: 8 Page: 124/241 Date: 27/10/2015
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (7)
PROC8a Transfer in non-dedicated facilities
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (8)
PROC8b Transfer at dedicated facilities
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour) 126/243
![Page 127: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/127.jpg)
Malic Acid
Revision: 8 Page: 125/241 Date: 27/10/2015
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (9)
PROC9 Filling small containers in dedicated lines
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (10)
PROC8a Maintenance and cleaning operations
127/243
![Page 128: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/128.jpg)
Malic Acid
Revision: 8 Page: 126/241 Date: 27/10/2015
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (11)
PROC15 Use as laboratory reagent
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 80%] 128/243
![Page 129: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/129.jpg)
Malic Acid
Revision: 8 Page: 127/241 Date: 27/10/2015
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed One hand face only (240 cm2)
Section 3: Exposure estimation and reference to its source
Contributing scenario controlling environmental exposure (1)
ERC2 Formulation of preparations
Release route Release rate Release estimation method
Water 14 kg/day ERC based
Air 17.5 kg/day ERC based Soil 0.07 kg/day ERC based Protection target Exposure estimation Risk characterisation ratio
Fresh water 0.089 mg/L 0.889
Sea water 0.009 mg/L 0.889
Sewage treatment plant 0.886 mg/L 0.295
Man via Environment - Inhalation 0.003 mg/m³ < 0.01
Man via Environment - Oral 0.417 mg/kg bw/day 0.07
Contributing scenario controlling worker exposure (1)
PROC1 Use in closed process, no likelihood of exposure
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.01 mg/m³ <0.01
Inhalation, Systemic effects, Acute 0.04 mg/m³ <0.01 Inhalation, Local effects, Long Term
0.01 mg/m³ <0.01
Inhalation, Local effects, Acute 0.04 mg/m³ <0.01 Dermal, Systemic effects, Long Term
0.007 mg/kg bw/day <0.01
Dermal, Local effects, Long Term 0.002 mg/cm2 <0.01 Combined routes, Systemic effects, Long Term
- <0.01
Combined routes, Systemic effects, Acute
- <0.01
129/243
![Page 130: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/130.jpg)
Malic Acid
Revision: 8 Page: 128/241 Date: 27/10/2015
Contributing scenario controlling worker exposure (2)
PROC2 Use in closed, continuous process with occasional controlled exposure
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.01 mg/m³ <0.01
Inhalation, Systemic effects, Acute 0.04 mg/m³ <0.01 Inhalation, Local effects, Long Term
0.01 mg/m³ <0.01
Inhalation, Local effects, Acute 0.04 mg/m³ <0.01 Dermal, Systemic effects, Long Term
0.274 mg/kg bw/day 0.137
Dermal, Local effects, Long Term 0.04 mg/cm2 0.04 Combined routes, Systemic effects, Long Term
- 0.139
Combined routes, Systemic effects, Acute
- <0.01
Contributing scenario controlling worker exposure (3)
PROC4 Use in batch and other process (synthesis) where opportunity for exposure arises
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.372 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.2 mg/cm2 0.2
Combined routes, Systemic effects, Long Term
- 0.78
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (4)
PROC8b Receiving and charging of the substance
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
130/243
![Page 131: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/131.jpg)
Malic Acid
Revision: 8 Page: 129/241 Date: 27/10/2015
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.1 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.4 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.704
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (5)
PROC3 Mixing, dispersing, completion in closed batch process
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.1 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.4 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
0.069 mg/kg bw/day 0.034
Dermal, Local effects, Long Term 0.02 mg/cm2 0.02
Combined routes, Systemic effects, Long Term
- 0.053
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (6)
PROC5 Mixing, dispersing and completion in open multistage batch process
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016 131/243
![Page 132: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/132.jpg)
Malic Acid
Revision: 8 Page: 130/241 Date: 27/10/2015
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.2 mg/cm2 0.2
Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (7)
PROC8a Transfer in non-dedicated facilities
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (8)
PROC8b Transfer at dedicated facilities
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.1 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.4 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic - 0.704 132/243
![Page 133: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/133.jpg)
Malic Acid
Revision: 8 Page: 131/241 Date: 27/10/2015
effects, Long Term
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (9)
PROC9 Filling small containers in dedicated lines
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.1 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.4 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
0.686 mg/kg bw/day 0.343
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.362
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (10)
PROC8a Maintenance and cleaning operations
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
133/243
![Page 134: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/134.jpg)
Malic Acid
Revision: 8 Page: 132/241 Date: 27/10/2015
Contributing scenario controlling worker exposure (11)
PROC15 Use as laboratory reagent
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.1 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.4 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
0.068 mg/kg bw/day 0.034
Dermal, Local effects, Long Term 0.02 mg/cm2 0.02
Combined routes, Systemic effects, Long Term
- 0.053
Combined routes, Systemic effects, Acute
- < 0.01
Section 4: Guidance to DU to evaluate whether he works inside the boundaries set by the ES
No additional risk management measures, besides those that are mentioned above, are needed to guarantee safe use for workers. Exposure Scenario 14: Use at industrial sites of dyestuffs and in textiles uses
Section 1: Title of exposure scenario
Chemical product category [PC] PC23 Leather tanning, dye, finishing, impregnation and care products PC26 Paper and board dye, finishing and impregnation products: including bleaches and other processing aids PC34 Textile dyes, finishing and impregnating products; including bleaches and other processing aids
Sectors of use [SU] SU5 Manufacture of textiles, leather, fur SU6b Manufacture of pulp, paper and paper products
Contributing scenario controlling environmental exposure
ERC6b Use at industrial site
Contributing scenario controlling worker exposure
PROC2 Application of dyestuffs in closed system with occasional controlled exposure PROC8b Raw material receipt and transfer PROC5 Preparation of dyestuffs application PROC8a Batch loading of equipment (manual, non dedicated) PROC7 Spray coating- any technique PROC10 Brushing, roller, spreader, flow coating or printing- any technique PROC13 Treatment of articles by dipping and pouring PROC2 Curing and drying processes after application- elevated temperature PROC8a Manual cleaning and maintenance of equipment
134/243
![Page 135: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/135.jpg)
Malic Acid
Revision: 8 Page: 133/241 Date: 27/10/2015
Subsequent service life exposure scenario(s)
ES 25 Service life (professional worker); Service life articles used by workers; SU 5; SU 6b; SU 11; SU 12; SU 13; SU 16; SU 17; SU 18; SU 19; SU 0
ES 26 Service life (consumers); Service life articles used by consumers
Section 2: Operational conditions of use
Contributing scenario controlling environmental exposure (1)
ERC6b Use at industrial site
Amounts used, Frequency and duration of use
Daily use at site ≤ 0.7 tonnes/day
Annual use at site ≤ 150 tonnes/year
Percentage of tonnage used at regional scale
10%
Conditions and measures related to municipal sewage treatment plant
Municipal STP Yes. [Effectiveness - Water: 87.34%]
Discharge rate of STP ≥ 2 X 103 m3/days
Application of the STP sludge on agricultural soil
Yes
Conditions and measures related to external treatment of waste for disposal
Particular considerations on the waste treatment operations: No (low risk) (ERC based assessment demonstrating control of risk with default conditions. Low risk assumed for waste life stage. Waste disposal according to national/local legislation is sufficient.)
Other given operational conditions affecting environmental exposure
Receiving surface water flow ≥ 1.8 X 104 m3/days
Contributing scenario controlling worker exposure (1)
PROC2 Application of dyestuffs in closed system with occasional controlled exposure
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Closed continuous process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
135/243
![Page 136: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/136.jpg)
Malic Acid
Revision: 8 Page: 134/241 Date: 27/10/2015
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (2)
PROC8b Raw material receipt and transfer
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (3)
PROC5 Preparation of dyestuffs application
Product (article) characteristic
Dustiness of material Low
Concentration of substance in >25% 136/243
![Page 137: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/137.jpg)
Malic Acid
Revision: 8 Page: 135/241 Date: 27/10/2015
mixture
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Good general ventilation (3-5 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (4)
PROC8a Batch loading of equipment (manual, non dedicated)
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%] 137/243
![Page 138: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/138.jpg)
Malic Acid
Revision: 8 Page: 136/241 Date: 27/10/2015
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (5)
PROC7 Spray coating- any technique
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Good general ventilation (3-5 air changes per hour)
Containment No.
Local exhaust ventilation Yes [Effectiveness - Inhalation: 95%]
Local exhaust ventilation (Dermal) Yes [Effectiveness - Dermal: 95%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 95%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands and upper wrists (1500 cm2)
Contributing scenario controlling worker exposure (6)
PROC10 Brushing, roller, spreader, flow coating or printing- any technique
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes 138/243
![Page 139: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/139.jpg)
Malic Acid
Revision: 8 Page: 137/241 Date: 27/10/2015
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 95%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (7)
PROC13 Treatment of articles by dipping and pouring
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure 139/243
![Page 140: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/140.jpg)
Malic Acid
Revision: 8 Page: 138/241 Date: 27/10/2015
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (8)
PROC2 Curing and drying processes after application- elevated temperature
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Closed continuous process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (9)
PROC8a Manual cleaning and maintenance of equipment
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker 140/243
![Page 141: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/141.jpg)
Malic Acid
Revision: 8 Page: 139/241 Date: 27/10/2015
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Section 3: Exposure estimation and reference to its source
Contributing scenario controlling environmental exposure (1)
ERC6b Use at industrial site
Release route Release rate Release estimation method
Water 14 kg/day Release factor
Air 0.7 kg/day Release factor
Soil 0.175 kg/day ERC based
Protection target Exposure estimation Risk characterisation ratio
Fresh water 0.089 mg/L 0.889
Sea water 0.009 mg/L 0.889
Sewage treatment plant 0.886 mg/L 0.295
Man via Environment - Inhalation 1.142 X 10-4 mg/m³ < 0.01
Man via Environment - Oral 0.018 mg/kg bw/day < 0.01
Contributing scenario controlling worker exposure (1)
PROC2 Application of dyestuffs in closed system with occasional controlled exposure
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.01 mg/m³ < 0.01
Inhalation, Systemic effects, Acute 0.04 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.01 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.04 mg/m³ < 0.01 141/243
![Page 142: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/142.jpg)
Malic Acid
Revision: 8 Page: 140/241 Date: 27/10/2015
Dermal, Systemic effects, Long Term
0.137 mg/kg bw/day 0.068
Dermal, Local effects, Long Term 0.02 mg/cm2 0.02
Combined routes, Systemic effects, Long Term
- 0.07
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (2)
PROC8b Raw material receipt and transfer
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.1 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.4 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.704
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (3)
PROC5 Preparation of dyestuffs application
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.35 mg/m³ 0.066
Inhalation, Systemic effects, Acute 1.4 mg/m³ 0.013
Inhalation, Local effects, Long Term
0.35 mg/m³ 0.011
Inhalation, Local effects, Acute 1.4 mg/m³ 0.013
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.2 mg/cm2 0.2
Combined routes, Systemic effects, Long Term
- 0.751 142/243
![Page 143: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/143.jpg)
Malic Acid
Revision: 8 Page: 141/241 Date: 27/10/2015
Combined routes, Systemic effects, Acute
- 0.013
Contributing scenario controlling worker exposure (4)
PROC8a Batch loading of equipment (manual, non dedicated)
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (5)
PROC7 Spray coating- any technique
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.035 mg/m³ < 0.01
Inhalation, Systemic effects, Acute 0.14 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.035 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.14 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
0.107 mg/kg bw/day 0.054
Dermal, Local effects, Long Term 0.005 mg/cm2 < 0.01
Combined routes, Systemic effects, Long Term
- 0.06
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (6)
PROC10 Brushing, roller, spreader, flow coating or printing- any technique
Method: TRA Worker v3 143/243
![Page 144: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/144.jpg)
Malic Acid
Revision: 8 Page: 142/241 Date: 27/10/2015
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.372 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.78
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (7)
PROC13 Treatment of articles by dipping and pouring
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.1 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.4 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.2 mg/cm2 0.2
Combined routes, Systemic effects, Long Term
- 0.704
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (8)
PROC2 Curing and drying processes after application- elevated temperature
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.01 mg/m³ < 0.01
Inhalation, Systemic effects, Acute 0.04 mg/m³ < 0.01 144/243
![Page 145: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/145.jpg)
Malic Acid
Revision: 8 Page: 143/241 Date: 27/10/2015
Inhalation, Local effects, Long Term
0.01 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.04 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
0.137 mg/kg bw/day 0.068
Dermal, Local effects, Long Term 0.02 mg/cm2 0.02
Combined routes, Systemic effects, Long Term
- 0.07
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (9)
PROC8a Manual cleaning and maintenance of equipment
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
Section 4: Guidance to DU to evaluate whether he works inside the boundaries set by the ES
No additional risk management measures, besides those that are mentioned above, are needed to guarantee safe use for workers.
145/243
![Page 146: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/146.jpg)
Malic Acid
Revision: 8 Page: 144/241 Date: 27/10/2015
Exposure Scenario 15: Formulation - construction products
Section 1: Title of exposure scenario
Chemical product category [PC] PC0 Other
Contributing scenario controlling environmental exposure
ERC2 Formulation of preparations
Contributing scenario controlling worker exposure
PROC1 Use in closed process, no likelihood of exposure PROC2 Use in closed, continuous process with occasional controlled exposure PROC4 Use in batch and other process (synthesis) where opportunity for exposure arises PROC8b Receiving and charging of the substance PROC3 Mixing, dispersing, completion in closed batch process PROC5 Mixing, dispersing and completion in open multistage batch process PROC8a Transfer in non-dedicated facilities PROC8b Transfer at dedicated facilities PROC9 Filling small containers in dedicated lines PROC8a Maintenance and cleaning operations PROC15 Use as laboratory reagent
Section 2: Operational conditions of use
Contributing scenario controlling environmental exposure (1)
ERC2 Formulation of preparations
Amounts used, Frequency and duration of use
Daily use at site ≤ 0.7 tonnes/day
Annual use at site ≤ 150 tonnes/year
Percentage of tonnage used at regional scale
100%
Conditions and measures related to municipal sewage treatment plant
Municipal STP Yes. [Effectiveness - Water: 87.34%]
Discharge rate of STP ≥ 2 X 103 m3/days
Application of the STP sludge on agricultural soil
Yes
Conditions and measures related to external treatment of waste for disposal
Particular considerations on the waste treatment operations: No (low risk) (ERC based assessment demonstrating control of risk with default conditions. Low risk assumed for waste life stage. Waste disposal according to national/local legislation is sufficient.)
Other given operational conditions affecting environmental exposure
Receiving surface water flow ≥ 1.8 X 104 m3/days
Contributing scenario controlling worker exposure (1)
PROC1 Use in closed process, no likelihood of exposure
Product (article) characteristic
Dustiness of material Low
Concentration of substance in Substance as such 146/243
![Page 147: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/147.jpg)
Malic Acid
Revision: 8 Page: 145/241 Date: 27/10/2015
mixture
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Use in closed systems. (minimal contact during routine operations)
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 80%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed One hand face only (240 cm2)
Contributing scenario controlling worker exposure (2)
PROC2 Use in closed, continuous process with occasional controlled exposure
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Closed continuous process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 80%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure 147/243
![Page 148: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/148.jpg)
Malic Acid
Revision: 8 Page: 146/241 Date: 27/10/2015
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (3)
PROC4 Use in batch and other process (synthesis) where opportunity for exposure arises
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 80%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (4)
PROC8b Receiving and charging of the substance
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%] 148/243
![Page 149: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/149.jpg)
Malic Acid
Revision: 8 Page: 147/241 Date: 27/10/2015
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (5)
PROC3 Mixing, dispersing, completion in closed batch process
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Closed batch process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed One hand face only (240 cm2)
Contributing scenario controlling worker exposure (6)
PROC5 Mixing, dispersing and completion in open multistage batch process
Product (article) characteristic
Dustiness of material Low
Concentration of substance in Substance as such 149/243
![Page 150: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/150.jpg)
Malic Acid
Revision: 8 Page: 148/241 Date: 27/10/2015
mixture
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (7)
PROC8a Transfer in non-dedicated facilities
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure 150/243
![Page 151: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/151.jpg)
Malic Acid
Revision: 8 Page: 149/241 Date: 27/10/2015
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (8)
PROC8b Transfer at dedicated facilities
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Good general ventilation (3-5 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 95%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (9)
PROC9 Filling small containers in dedicated lines
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%] 151/243
![Page 152: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/152.jpg)
Malic Acid
Revision: 8 Page: 150/241 Date: 27/10/2015
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (10)
PROC8a Maintenance and cleaning operations
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (11)
PROC15 Use as laboratory reagent
Product (article) characteristic
Dustiness of material Low
Concentration of substance in Substance as such 152/243
![Page 153: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/153.jpg)
Malic Acid
Revision: 8 Page: 151/241 Date: 27/10/2015
mixture
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 80%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed One hand face only (240 cm2)
Section 3: Exposure estimation and reference to its source
Contributing scenario controlling environmental exposure (1)
ERC2 Formulation of preparations
Release route Release rate Release estimation method
Water 14 kg/day ERC based
Air 17.5 kg/day ERC based Soil 0.07 kg/day ERC based Protection target Exposure estimation Risk characterisation ratio
Fresh water 0.089 mg/L 0.889
Sea water 0.009 mg/L 0.889
Sewage treatment plant 0.886 mg/L 0.295
Man via Environment - Inhalation 0.003 mg/m³ < 0.01
Man via Environment - Oral 0.417 mg/kg bw/day 0.07
Contributing scenario controlling worker exposure (1)
PROC1 Use in closed process, no likelihood of exposure
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, 0.01 mg/m³ <0.01 153/243
![Page 154: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/154.jpg)
Malic Acid
Revision: 8 Page: 152/241 Date: 27/10/2015
Long Term
Inhalation, Systemic effects, Acute 0.04 mg/m³ <0.01 Inhalation, Local effects, Long Term
0.01 mg/m³ <0.01
Inhalation, Local effects, Acute 0.04 mg/m³ <0.01 Dermal, Systemic effects, Long Term
0.007 mg/kg bw/day <0.01
Dermal, Local effects, Long Term 0.002 mg/cm2 <0.01 Combined routes, Systemic effects, Long Term
- <0.01
Combined routes, Systemic effects, Acute
- <0.01
Contributing scenario controlling worker exposure (2)
PROC2 Use in closed, continuous process with occasional controlled exposure
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.01 mg/m³ <0.01
Inhalation, Systemic effects, Acute 0.04 mg/m³ <0.01 Inhalation, Local effects, Long Term
0.01 mg/m³ <0.01
Inhalation, Local effects, Acute 0.04 mg/m³ <0.01 Dermal, Systemic effects, Long Term
0.274 mg/kg bw/day 0.137
Dermal, Local effects, Long Term 0.04 mg/cm2 0.04 Combined routes, Systemic effects, Long Term
- 0.139
Combined routes, Systemic effects, Acute
- <0.01
Contributing scenario controlling worker exposure (3)
PROC4 Use in batch and other process (synthesis) where opportunity for exposure arises
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019 154/243
![Page 155: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/155.jpg)
Malic Acid
Revision: 8 Page: 153/241 Date: 27/10/2015
Dermal, Systemic effects, Long Term
1.372 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.2 mg/cm2 0.2
Combined routes, Systemic effects, Long Term
- 0.78
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (4)
PROC8b Receiving and charging of the substance
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.1 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.4 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.704
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (5)
PROC3 Mixing, dispersing, completion in closed batch process
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.1 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.4 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
0.069 mg/kg bw/day 0.034
Dermal, Local effects, Long Term 0.02 mg/cm2 0.02
Combined routes, Systemic effects, Long Term
- 0.053 155/243
![Page 156: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/156.jpg)
Malic Acid
Revision: 8 Page: 154/241 Date: 27/10/2015
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (6)
PROC5 Mixing, dispersing and completion in open multistage batch process
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.2 mg/cm2 0.2
Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (7)
PROC8a Transfer in non-dedicated facilities
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (8)
PROC8b Transfer at dedicated facilities
Method: TRA Worker v3 156/243
![Page 157: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/157.jpg)
Malic Acid
Revision: 8 Page: 155/241 Date: 27/10/2015
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.07 mg/m³ 0.013
Inhalation, Systemic effects, Acute 0.28 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.07 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.28 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
0.686 mg/kg bw/day 0.343
Dermal, Local effects, Long Term 0.05 mg/cm2 0.05
Combined routes, Systemic effects, Long Term
- 0.356
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (9)
PROC9 Filling small containers in dedicated lines
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.1 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.4 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
0.686 mg/kg bw/day 0.343
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.362
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (10)
PROC8a Maintenance and cleaning operations
Method: TRA Worker v3
157/243
![Page 158: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/158.jpg)
Malic Acid
Revision: 8 Page: 156/241 Date: 27/10/2015
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (11)
PROC15 Use as laboratory reagent
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.1 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.4 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
0.068 mg/kg bw/day 0.034
Dermal, Local effects, Long Term 0.02 mg/cm2 0.02
Combined routes, Systemic effects, Long Term
- 0.053
Combined routes, Systemic effects, Acute
- < 0.01
Section 4: Guidance to DU to evaluate whether he works inside the boundaries set by the ES
No additional risk management measures, besides those that are mentioned above, are needed to guarantee safe use for workers.
158/243
![Page 159: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/159.jpg)
Malic Acid
Revision: 8 Page: 157/241 Date: 27/10/2015
Exposure Scenario 16: Use at industrial sites in construction products
Section 1: Title of exposure scenario
Chemical product category [PC] PC0 Other
Sectors of use [SU] SU19 Building and construction work
Contributing scenario controlling environmental exposure
ERC7 Use at industrial site
Contributing scenario controlling worker exposure
PROC8b Raw material receipt and transfer PROC3 Use in closed batch process (synthesis or formulation) PROC2 Use in closed, continuous process with occasional controlled exposure PROC5 Mixing or blending in batch processes for formulation of preparations and articles (multistage and/or significant contact) PROC6 Calendering operations PROC8a Transfer in non-dedicated facilities PROC8a Maintenance and cleaning operations
Subsequent service life exposure scenario(s)
ES 25 Service life (professional worker); Service life articles used by workers; SU 5; SU 6b; SU 11; SU 12; SU 13; SU 16; SU 17; SU 18; SU 19; SU 0
ES 26 Service life (consumers); Service life articles used by consumers
Section 2: Operational conditions of use
Contributing scenario controlling environmental exposure (1)
ERC7 Use at industrial site
Amounts used, Frequency and duration of use
Daily use at site ≤ 0.7 tonnes/day
Annual use at site ≤ 150 tonnes/year
Percentage of tonnage used at regional scale
10%
Conditions and measures related to municipal sewage treatment plant
Municipal STP Yes. [Effectiveness - Water: 87.34%]
Discharge rate of STP ≥ 2 X 103 m3/days
Application of the STP sludge on agricultural soil
Yes
Conditions and measures related to external treatment of waste for disposal
Particular considerations on the waste treatment operations: No (low risk) (ERC based assessment demonstrating control of risk with default conditions. Low risk assumed for waste life stage. Waste disposal according to national/local legislation is sufficient.)
Other given operational conditions affecting environmental exposure
Receiving surface water flow ≥ 1.8 X 104 m3/days
Contributing scenario controlling worker exposure (1)
PROC8b Raw material receipt and transfer
159/243
![Page 160: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/160.jpg)
Malic Acid
Revision: 8 Page: 158/241 Date: 27/10/2015
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Good general ventilation (3-5 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (2)
PROC3 Use in closed batch process (synthesis or formulation)
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Closed batch process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
160/243
![Page 161: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/161.jpg)
Malic Acid
Revision: 8 Page: 159/241 Date: 27/10/2015
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed One hand face only (240 cm2)
Contributing scenario controlling worker exposure (3)
PROC2 Use in closed, continuous process with occasional controlled exposure
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Closed batch process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (4)
PROC5 Mixing or blending in batch processes for formulation of preparations and articles (multistage and/or significant contact) 161/243
![Page 162: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/162.jpg)
Malic Acid
Revision: 8 Page: 160/241 Date: 27/10/2015
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (5)
PROC6 Calendering operations
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
162/243
![Page 163: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/163.jpg)
Malic Acid
Revision: 8 Page: 161/241 Date: 27/10/2015
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 95%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (6)
PROC8a Transfer in non-dedicated facilities
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (7)
PROC8a Maintenance and cleaning operations
Product (article) characteristic
Dustiness of material Low
163/243
![Page 164: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/164.jpg)
Malic Acid
Revision: 8 Page: 162/241 Date: 27/10/2015
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Section 3: Exposure estimation and reference to its source
Contributing scenario controlling environmental exposure (1)
ERC7 Use at industrial site
Release route Release rate Release estimation method
Water 14 kg/day Release factor
Air 0.7 kg/day Release factor
Soil 35 kg/day ERC based
Protection target Exposure estimation Risk characterisation ratio
Fresh water 0.089 mg/L 0.889
Sea water 0.009 mg/L 0.889
Sewage treatment plant 0.886 mg/L 0.295
Man via Environment - Inhalation 1.142 X 10-4 mg/m³ < 0.01
Man via Environment - Oral 0.018 mg/kg bw/day < 0.01
Contributing scenario controlling worker exposure (1)
PROC8b Raw material receipt and transfer
Method: TRA Worker v3 164/243
![Page 165: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/165.jpg)
Malic Acid
Revision: 8 Page: 163/241 Date: 27/10/2015
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.07 mg/m³ 0.013
Inhalation, Systemic effects, Acute 0.28 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.07 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.28 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.699
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (2)
PROC3 Use in closed batch process (synthesis or formulation)
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.1 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.4 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
0.069 mg/kg bw/day 0.034
Dermal, Local effects, Long Term 0.02 mg/cm2 0.02
Combined routes, Systemic effects, Long Term
- 0.053
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (3)
PROC2 Use in closed, continuous process with occasional controlled exposure
Method: TRA Worker v3
165/243
![Page 166: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/166.jpg)
Malic Acid
Revision: 8 Page: 164/241 Date: 27/10/2015
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.01 mg/m³ < 0.01
Inhalation, Systemic effects, Acute 0.04 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.01 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.04 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
0.137 mg/kg bw/day 0.068
Dermal, Local effects, Long Term 0.02 mg/cm2 0.02
Combined routes, Systemic effects, Long Term
- 0.07
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (4)
PROC5 Mixing or blending in batch processes for formulation of preparations and articles (multistage and/or significant contact)
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.2 mg/cm2 0.2
Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (5)
PROC6 Calendering operations
Method: TRA Worker v3
166/243
![Page 167: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/167.jpg)
Malic Acid
Revision: 8 Page: 165/241 Date: 27/10/2015
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.1 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.4 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
1.372 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.704
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (6)
PROC8a Transfer in non-dedicated facilities
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (7)
PROC8a Maintenance and cleaning operations
Method: TRA Worker v3
167/243
![Page 168: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/168.jpg)
Malic Acid
Revision: 8 Page: 166/241 Date: 27/10/2015
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
Section 4: Guidance to DU to evaluate whether he works inside the boundaries set by the ES
No additional risk management measures, besides those that are mentioned above, are needed to guarantee safe use for workers. Exposure Scenario 17: Professional creation of building materials and articles
Section 1: Title of exposure scenario
Chemical product category [PC] PC0 Other
Sectors of use [SU] SU19 Building and construction work
Contributing scenario controlling environmental exposure
ERC 8f, ERC 8c Professional use of building materials and articles creation
Contributing scenario controlling worker exposure
PROC8a Transfer in non-dedicated facilities PROC5 Mixing operations PROC14 Article preparation PROC24 High energy processing PROC8a Maintenance and cleaning operations
Subsequent service life exposure scenario(s)
ES 25 Service life (professional worker); Service life articles used by workers; SU 5; SU 6b; SU 11; SU 12; SU 13; SU 16; SU 17; SU 18; SU 19; SU 0
ES 26 Service life (consumers); Service life articles used by consumers
Section 2: Operational conditions of use
Contributing scenario controlling environmental exposure (1)
ERC 8f Professional use of building materials and articles creation
Amounts used, Frequency and duration of use
Daily use at site ≤ 8.25 X 10-5 tonnes/day
Percentage of tonnage used at regional scale
10%
168/243
![Page 169: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/169.jpg)
Malic Acid
Revision: 8 Page: 167/241 Date: 27/10/2015
Conditions and measures related to municipal sewage treatment plant
Municipal STP Yes. [Effectiveness - Water: 87.34%]
Discharge rate of STP ≥ 2 X 103 m3/days
Application of the STP sludge on agricultural soil
Yes
Conditions and measures related to external treatment of waste for disposal
Particular considerations on the waste treatment operations: No (low risk) (ERC based assessment demonstrating control of risk with default conditions. Low risk assumed for waste life stage. Waste disposal according to national/local legislation is sufficient.)
Other given operational conditions affecting environmental exposure
Receiving surface water flow ≥ 1.8 X 104 m3/days
Contributing scenario controlling worker exposure (1)
PROC8a Transfer in non-dedicated facilities
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (2)
PROC5 Mixing operations
Product (article) characteristic 169/243
![Page 170: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/170.jpg)
Malic Acid
Revision: 8 Page: 168/241 Date: 27/10/2015
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (3)
PROC14 Article preparation
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Basic
Conditions and measures related to personal protection, hygiene and health evaluation 170/243
![Page 171: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/171.jpg)
Malic Acid
Revision: 8 Page: 169/241 Date: 27/10/2015
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (4)
PROC24 High energy processing
Product (article) characteristic
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Basic
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature > melting point
Skin surface potentially exposed Two hands and forearms (1980 cm2)
Contributing scenario controlling worker exposure (5)
PROC8a Maintenance and cleaning operations
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes 171/243
![Page 172: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/172.jpg)
Malic Acid
Revision: 8 Page: 170/241 Date: 27/10/2015
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Basic
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Section 3: Exposure estimation and reference to its source
Contributing scenario controlling environmental exposure (1)
ERC 8f Professional use of building materials and articles creation
Release route Release rate Release estimation method
Water 8.25 X 10-4 kg/day ERC based
Air 0.012 kg/day ERC based
Soil 4.125 X 10-4 kg/day ERC based
Protection target Exposure estimation Risk characterisation ratio
Fresh water 2.692 X 10-4 mg/L < 0.01
Sea water 2.573 X 10-5 mg/L < 0.01
Sewage treatment plant 5.221 X 10-5 mg/L < 0.01
Man via Environment - Inhalation 2.912 X 10-11 mg/m³ < 0.01
Man via Environment - Oral 7.287 X 10-5 mg/kg bw/day < 0.01
Contributing scenario controlling worker exposure (1)
PROC8a Transfer in non-dedicated facilities
Method: TRA Worker v3
172/243
![Page 173: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/173.jpg)
Malic Acid
Revision: 8 Page: 171/241 Date: 27/10/2015
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (2)
PROC5 Mixing operations
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
1 mg/m³ 0.188
Inhalation, Systemic effects, Acute 4 mg/m³ 0.038
Inhalation, Local effects, Long Term
1 mg/m³ 0.031
Inhalation, Local effects, Acute 4 mg/m³ 0.038
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.2 mg/cm2 0.2
Combined routes, Systemic effects, Long Term
- 0.873
Combined routes, Systemic effects, Acute
- 0.038
Contributing scenario controlling worker exposure (3)
PROC14 Article preparation
Method: TRA Worker v3
173/243
![Page 174: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/174.jpg)
Malic Acid
Revision: 8 Page: 172/241 Date: 27/10/2015
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
1 mg/m³ 0.188
Inhalation, Systemic effects, Acute 4 mg/m³ 0.038
Inhalation, Local effects, Long Term
1 mg/m³ 0.031
Inhalation, Local effects, Acute 4 mg/m³ 0.038
Dermal, Systemic effects, Long Term
0.343 mg/kg bw/day 0.172
Dermal, Local effects, Long Term 0.05 mg/cm2 0.05
Combined routes, Systemic effects, Long Term
- 0.359
Combined routes, Systemic effects, Acute
- 0.038
Contributing scenario controlling worker exposure (4)
PROC24 High energy processing
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
2 mg/m³ 0.375
Inhalation, Systemic effects, Acute 8 mg/m³ 0.077
Inhalation, Local effects, Long Term
2 mg/m³ 0.062
Inhalation, Local effects, Acute 8 mg/m³ 0.077
Dermal, Systemic effects, Long Term
0.283 mg/kg bw/day 0.142
Dermal, Local effects, Long Term 0.01 mg/cm2 0.01
Combined routes, Systemic effects, Long Term
- 0.517
Combined routes, Systemic effects, Acute
- 0.077
Contributing scenario controlling worker exposure (5)
PROC8a Maintenance and cleaning operations
Method: TRA Worker v3
174/243
![Page 175: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/175.jpg)
Malic Acid
Revision: 8 Page: 173/241 Date: 27/10/2015
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
Section 4: Guidance to DU to evaluate whether he works inside the boundaries set by the ES
No additional risk management measures, besides those that are mentioned above, are needed to guarantee safe use for workers. Exposure Scenario 18: Consumer building product use
Section 1: Title of exposure scenario
Chemical product category [PC] PC0 Other
Contributing scenario controlling environmental exposure
ERC8f, ERC8c Consumer building product use
Contributing scenario controlling consumer exposure
PC0 Use of building products
Subsequent service life exposure scenario(s)
ES 25 Service life (professional worker); Service life articles used by workers; SU 5; SU 6b; SU 11; SU 12; SU 13; SU 16; SU 17; SU 18; SU 19; SU 0
ES 26 Service life (consumers); Service life articles used by consumers
Section 2: Operational conditions of use
Contributing scenario controlling environmental exposure (1)
ERC8f Consumer building product use
Amounts used, Frequency and duration of use
Daily wide dispersive use ≤ 8.25 X 10-5 tonnes/day
Percentage of tonnage used at regional scale
10%
Conditions and measures related to municipal sewage treatment plant
Municipal STP Yes. [Effectiveness - Water: 87.34%]
Discharge rate of STP ≥ 2 X 103 m3/days
175/243
![Page 176: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/176.jpg)
Malic Acid
Revision: 8 Page: 174/241 Date: 27/10/2015
Application of the STP sludge on agricultural soil
Yes
Conditions and measures related to external treatment of waste for disposal
Particular considerations on the waste treatment operations: No (low risk) (ERC based assessment demonstrating control of risk with default conditions. Low risk assumed for waste life stage. Waste disposal according to national/local legislation is sufficient.)
Other given operational conditions affecting environmental exposure
Receiving surface water flow ≥ 1.8 X 104 m3/days
Contributing scenario controlling consumer exposure (1)
PC0 Use of building products
Product (article) characteristic
Product/ Article subcategory No value
Concentration of substance in mixture
0.1 g/g
Section 3: Exposure estimation and reference to its source
Contributing scenario controlling environmental exposure (1)
ERC8f Consumer building product use
Release route Release rate Release estimation method
Water 8.25 X 10-4 kg/day ERC based
Air 0.012 kg/day ERC based
Soil 4.125 X 10-4 kg/day ERC based
Protection target Exposure estimation Risk characterisation ratio
Fresh water 2.692 X 10-4 mg/L <0.01 Sea water 2.573 X 10-5 mg/L <0.01 Sewage treatment plant 5.221 X 10-5 mg/L <0.01 Man via Environment - Inhalation 2.912 X 10-11 mg/m³ <0.01 Man via Environment - Oral 7.287 X 10-5 mg/kg bw/day <0.01 Contributing scenario controlling consumer exposure (1)
PC0 Use of building products
Not available
Section 4: Guidance to DU to evaluate whether he works inside the boundaries set by the ES
No additional risk management measures, besides those that are mentioned above, are needed to guarantee safe use for workers.
176/243
![Page 177: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/177.jpg)
Malic Acid
Revision: 8 Page: 175/241 Date: 27/10/2015
Exposure Scenario 19: Formulation - Coatings and Inks
Section 1: Title of exposure scenario
Chemical product category [PC] PC9a Coatings and paints, thinners, paint removers PC14 Metal surface treatment products, including galvanic and electroplating products PC18 Ink and toners
Contributing scenario controlling environmental exposure
ERC2 Formulation of preparations
Contributing scenario controlling worker exposure
PROC1 Use in closed process, no likelihood of exposure PROC2 Use in closed, continuous process with occasional controlled exposure PROC4 Use in batch and other process (synthesis) where opportunity for exposure arises PROC8b Receiving and charging of the substance PROC3 Mixing, dispersing, completion in closed batch process PROC5 Mixing, dispersing and completion in open multistage batch process PROC9 Filling small containers in dedicated lines PROC8a Transfer in non-dedicated facilities PROC8b Transfer at dedicated facilities PROC8a Maintenance and cleaning operations PROC15 Use as laboratory reagent
Section 2: Operational conditions of use
Contributing scenario controlling environmental exposure (1)
ERC2 Formulation of preparations
Amounts used, Frequency and duration of use
Daily use at site ≤ 0.7 tonnes/day
Annual use at site ≤ 150 tonnes/year
Percentage of tonnage used at regional scale
100%
Conditions and measures related to municipal sewage treatment plant
Municipal STP Yes. [Effectiveness - Water: 87.34%]
Discharge rate of STP ≥ 2 X 103 m3/days
Application of the STP sludge on agricultural soil
Yes
Conditions and measures related to external treatment of waste for disposal
Particular considerations on the waste treatment operations: No (low risk) (ERC based assessment demonstrating control of risk with default conditions. Low risk assumed for waste life stage. Waste disposal according to national/local legislation is sufficient.)
Other given operational conditions affecting environmental exposure
Receiving surface water flow ≥ 1.8 X 104 m3/days
Contributing scenario controlling worker exposure (1)
PROC1 Use in closed process, no likelihood of exposure
177/243
![Page 178: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/178.jpg)
Malic Acid
Revision: 8 Page: 176/241 Date: 27/10/2015
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Use in closed systems. (minimal contact during routine operations)
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 80%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed One hand face only (240 cm2)
Contributing scenario controlling worker exposure (2)
PROC2 Use in closed, continuous process with occasional controlled exposure
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Closed continuous process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 80%] 178/243
![Page 179: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/179.jpg)
Malic Acid
Revision: 8 Page: 177/241 Date: 27/10/2015
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (3)
PROC4 Use in batch and other process (synthesis) where opportunity for exposure arises
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 80%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (4)
PROC8b Receiving and charging of the substance
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s) 179/243
![Page 180: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/180.jpg)
Malic Acid
Revision: 8 Page: 178/241 Date: 27/10/2015
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (5)
PROC3 Mixing, dispersing, completion in closed batch process
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Closed batch process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed One hand face only (240 cm2) 180/243
![Page 181: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/181.jpg)
Malic Acid
Revision: 8 Page: 179/241 Date: 27/10/2015
Contributing scenario controlling worker exposure (6)
PROC5 Mixing, dispersing and completion in open multistage batch process
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (7)
PROC9 Filling small containers in dedicated lines
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
181/243
![Page 182: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/182.jpg)
Malic Acid
Revision: 8 Page: 180/241 Date: 27/10/2015
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (8)
PROC8a Transfer in non-dedicated facilities
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (9)
PROC8b Transfer at dedicated facilities
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such 182/243
![Page 183: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/183.jpg)
Malic Acid
Revision: 8 Page: 181/241 Date: 27/10/2015
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Good general ventilation (3-5 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 95%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (10)
PROC8a Maintenance and cleaning operations
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use 183/243
![Page 184: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/184.jpg)
Malic Acid
Revision: 8 Page: 182/241 Date: 27/10/2015
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (11)
PROC15 Use as laboratory reagent
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 80%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature < melting point
Skin surface potentially exposed One hand face only (240 cm2)
Section 3: Exposure estimation and reference to its source
Contributing scenario controlling environmental exposure (1)
ERC2 Formulation of preparations
Release route Release rate Release estimation method
Water 7 kg/day Release factor
Air 4.2 kg/day Release factor Soil 0 kg/day Release factor Protection target Exposure estimation Risk characterisation ratio
Fresh water 0.045 mg/L 0.446
Sea water 0.004 mg/L 0.446
Sewage treatment plant 0.443 mg/L 0.148
Man via Environment - Inhalation 6.855 X 10-4 mg/m³ < 0.01 184/243
![Page 185: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/185.jpg)
Malic Acid
Revision: 8 Page: 183/241 Date: 27/10/2015
Man via Environment - Oral 0.101 mg/kg bw/day 0.017
Contributing scenario controlling worker exposure (1)
PROC1 Use in closed process, no likelihood of exposure
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.01 mg/m³ <0.01
Inhalation, Systemic effects, Acute 0.04 mg/m³ <0.01 Inhalation, Local effects, Long Term
0.01 mg/m³ <0.01
Inhalation, Local effects, Acute 0.04 mg/m³ <0.01 Dermal, Systemic effects, Long Term
0.007 mg/kg bw/day <0.01
Dermal, Local effects, Long Term 0.002 mg/cm2 <0.01 Combined routes, Systemic effects, Long Term
- <0.01
Combined routes, Systemic effects, Acute
- <0.01
Contributing scenario controlling worker exposure (2)
PROC2 Use in closed, continuous process with occasional controlled exposure
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.01 mg/m³ <0.01
Inhalation, Systemic effects, Acute 0.04 mg/m³ <0.01 Inhalation, Local effects, Long Term
0.01 mg/m³ <0.01
Inhalation, Local effects, Acute 0.04 mg/m³ <0.01 Dermal, Systemic effects, Long Term
0.274 mg/kg bw/day 0.137
Dermal, Local effects, Long Term 0.04 mg/cm2 0.04 Combined routes, Systemic effects, Long Term
- 0.139
Combined routes, Systemic effects, Acute
- <0.01
185/243
![Page 186: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/186.jpg)
Malic Acid
Revision: 8 Page: 184/241 Date: 27/10/2015
Contributing scenario controlling worker exposure (3)
PROC4 Use in batch and other process (synthesis) where opportunity for exposure arises
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.372 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.2 mg/cm2 0.2
Combined routes, Systemic effects, Long Term
- 0.78
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (4)
PROC8b Receiving and charging of the substance
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.1 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.4 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.704
Combined routes, Systemic effects, Acute
- < 0.01
186/243
![Page 187: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/187.jpg)
Malic Acid
Revision: 8 Page: 185/241 Date: 27/10/2015
Contributing scenario controlling worker exposure (5)
PROC3 Mixing, dispersing, completion in closed batch process
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.1 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.4 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
0.069 mg/kg bw/day 0.034
Dermal, Local effects, Long Term 0.02 mg/cm2 0.02
Combined routes, Systemic effects, Long Term
- 0.053
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (6)
PROC5 Mixing, dispersing and completion in open multistage batch process
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.2 mg/cm2 0.2
Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
187/243
![Page 188: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/188.jpg)
Malic Acid
Revision: 8 Page: 186/241 Date: 27/10/2015
Contributing scenario controlling worker exposure (7)
PROC9 Filling small containers in dedicated lines
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.1 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.4 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
0.686 mg/kg bw/day 0.343
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.362
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (8)
PROC8a Transfer in non-dedicated facilities
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
188/243
![Page 189: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/189.jpg)
Malic Acid
Revision: 8 Page: 187/241 Date: 27/10/2015
Contributing scenario controlling worker exposure (9)
PROC8b Transfer at dedicated facilities
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.07 mg/m³ 0.013
Inhalation, Systemic effects, Acute 0.28 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.07 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.28 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
0.686 mg/kg bw/day 0.343
Dermal, Local effects, Long Term 0.05 mg/cm2 0.05
Combined routes, Systemic effects, Long Term
- 0.356
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (10)
PROC8a Maintenance and cleaning operations
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (11)
PROC15 Use as laboratory reagent
Method: TRA Worker v3
189/243
![Page 190: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/190.jpg)
Malic Acid
Revision: 8 Page: 188/241 Date: 27/10/2015
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.1 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.4 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
0.068 mg/kg bw/day 0.034
Dermal, Local effects, Long Term 0.02 mg/cm2 0.02
Combined routes, Systemic effects, Long Term
- 0.053
Combined routes, Systemic effects, Acute
- < 0.01
Section 4: Guidance to DU to evaluate whether he works inside the boundaries set by the ES
No additional risk management measures, besides those that are mentioned above, are needed to guarantee safe use for workers. Exposure Scenario 20: Use at industrial site - General Industrial use of coatings and inks
Section 1: Title of exposure scenario
Chemical product category [PC] PC9a Coatings and paints, thinners, paint removers PC14 Metal surface treatment products, including galvanic and electroplating products PC18 Ink and toners
Sectors of use [SU] SU6b Manufacture of pulp, paper and paper products SU7 Printing and reproduction of recorded media SU16 Manufacture of computer, electronic and optical products, electrical equipment SU17 General manufacturing, e.g. machinery, equipment, vehicles, other transport equipment
Contributing scenario controlling environmental exposure
ERC5 Industrial use of coatings and inks involving water ERC5 Industrial use of coatings and inks water-free
Contributing scenario controlling worker exposure
PROC2 Application of coating and inks in closed system with occasional controlled exposure PROC8b Raw material receipt and transfer PROC5 Preparation of coating and inks application PROC8a Batch loading of equipment (manual, non dedicated) PROC7 Spray coating- any technique PROC10 Brushing, roller, spreader, flow coating or printing- any technique PROC13 Treatment of articles by dipping and pouring PROC2 Curing and drying processes after application- elevated temperature PROC8a Manual cleaning and maintenance of equipment
190/243
![Page 191: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/191.jpg)
Malic Acid
Revision: 8 Page: 189/241 Date: 27/10/2015
Subsequent service life exposure scenario(s)
ES 25 Service life (professional worker); Service life articles used by workers; SU 5; SU 6b; SU 11; SU 12; SU 13; SU 16; SU 17; SU 18; SU 19; SU 0
ES 26 Service life (consumers); Service life articles used by consumers
Section 2: Operational conditions of use
Contributing scenario controlling environmental exposure (1)
ERC5 Industrial use of coatings and inks involving water
Amounts used, Frequency and duration of use
Daily use at site ≤ 0.7 tonnes/day
Annual use at site ≤ 150 tonnes/year
Percentage of tonnage used at regional scale
10%
Conditions and measures related to municipal sewage treatment plant
Municipal STP Yes. [Effectiveness - Water: 100%]
Discharge rate of STP ≥ 2 X 103 m3/days
Application of the STP sludge on agricultural soil
Yes
Conditions and measures related to external treatment of waste for disposal
Particular considerations on the waste treatment operations: No (low risk) (ERC based assessment demonstrating control of risk with default conditions. Low risk assumed for waste life stage. Waste disposal according to national/local legislation is sufficient.)
Other given operational conditions affecting environmental exposure
Receiving surface water flow ≥ 1.8 X 104 m3/days
Contributing scenario controlling environmental exposure (2)
ERC5 Industrial use of coatings and inks water-free
Amounts used, Frequency and duration of use
Daily use at site ≤ 0.1 tonnes/day
Annual use at site ≤ 150 tonnes/year
Percentage of tonnage used at regional scale
10%
Conditions and measures related to municipal sewage treatment plant
Municipal STP Yes. [Effectiveness - Water: 87.34%]
Discharge rate of STP ≥ 2 X 103 m3/days
Application of the STP sludge on agricultural soil
Yes
191/243
![Page 192: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/192.jpg)
Malic Acid
Revision: 8 Page: 190/241 Date: 27/10/2015
Conditions and measures related to external treatment of waste for disposal
Particular considerations on the waste treatment operations: No (low risk) (ERC based assessment demonstrating control of risk with default conditions. Low risk assumed for waste life stage. Waste disposal according to national/local legislation is sufficient.)
Other given operational conditions affecting environmental exposure
Receiving surface water flow ≥ 1.8 X 104 m3/days
Contributing scenario controlling worker exposure (1)
PROC2 Application of coatings and inks in closed system with occasional controlled exposure
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Closed continuous process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (2)
PROC8b Raw material receipt and transfer
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
5-25%
Solid in solid mixtures Yes 192/243
![Page 193: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/193.jpg)
Malic Acid
Revision: 8 Page: 191/241 Date: 27/10/2015
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (3)
PROC5 Preparation of coatings and inks application
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
193/243
![Page 194: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/194.jpg)
Malic Acid
Revision: 8 Page: 192/241 Date: 27/10/2015
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (4)
PROC8a Batch loading of equipment (manual, non dedicated)
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (5)
PROC7 Spray coating- any technique
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
194/243
![Page 195: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/195.jpg)
Malic Acid
Revision: 8 Page: 193/241 Date: 27/10/2015
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation Yes [Effectiveness - Inhalation: 95%]
Local exhaust ventilation (Dermal) Yes [Effectiveness - Dermal: 95%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 95%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands and upper wrists (1500 cm2)
Contributing scenario controlling worker exposure (6)
PROC10 Brushing, roller, spreader, flow coating or printing- any technique
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 95%]
Respiratory protection No. [Effectiveness - Inhalation: 0%] 195/243
![Page 196: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/196.jpg)
Malic Acid
Revision: 8 Page: 194/241 Date: 27/10/2015
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (7)
PROC13 Treatment of articles by dipping and pouring
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (8)
PROC2 Curing and drying processes after application- elevated temperature
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
196/243
![Page 197: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/197.jpg)
Malic Acid
Revision: 8 Page: 195/241 Date: 27/10/2015
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Closed continuous process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (9)
PROC8a Manual cleaning and maintenance of equipment
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield 197/243
![Page 198: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/198.jpg)
Malic Acid
Revision: 8 Page: 196/241 Date: 27/10/2015
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Section 3: Exposure estimation and reference to its source
Contributing scenario controlling environmental exposure (1)
ERC5 Industrial use of coatings and inks involving water
Release route Release rate Release estimation method
Water 0 kg/day SpERC based
Air 11.9 kg/day SpERC based
Soil 0 kg/day SpERC based
Protection target Exposure estimation Risk characterisation ratio
Fresh water 2.64 X 10-4 mg/L < 0.01
Sea water 2.521 X 10-5 mg/L < 0.01
Sewage treatment plant 0 mg/L < 0.01
Man via Environment - Inhalation 0.002 mg/m³ < 0.01
Man via Environment - Oral 0.283 mg/kg bw/day 0.047
Contributing scenario controlling environmental exposure (2)
ERC5 Industrial use of coatings and inks water-free
Release route Release rate Release estimation method
Water 0.3 kg/day SpERC based
Air 0 kg/day SpERC based
Soil 0 kg/day SpERC based
Protection target Exposure estimation Risk characterisation ratio
Fresh water 0.002 mg/L 0.022
Sea water 2.151 X 10-4 mg/L 0.022
Sewage treatment plant 0.019 mg/L < 0.01
Man via Environment - Inhalation 2.919 X 10-11 mg/m³ < 0.01
Man via Environment - Oral 2.652 X 10-4 mg/kg bw/day < 0.01
Contributing scenario controlling worker exposure (1)
PROC2 Application of coating and inks in closed system with occasional controlled exposure
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.01 mg/m³ < 0.01 198/243
![Page 199: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/199.jpg)
Malic Acid
Revision: 8 Page: 197/241 Date: 27/10/2015
Inhalation, Systemic effects, Acute 0.04 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.01 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.04 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
0.137 mg/kg bw/day 0.068
Dermal, Local effects, Long Term 0.02 mg/cm2 0.02
Combined routes, Systemic effects, Long Term
- 0.07
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (2)
PROC8b Raw material receipt and transfer
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.06 mg/m³ 0.011
Inhalation, Systemic effects, Acute 0.24 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.06 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.24 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
0.823 mg/kg bw/day 0.411
Dermal, Local effects, Long Term 0.06 mg/cm2 0.06
Combined routes, Systemic effects, Long Term
- 0.423
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (3)
PROC5 Preparation of coating and inks application
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, 1.371 mg/kg bw/day 0.686 199/243
![Page 200: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/200.jpg)
Malic Acid
Revision: 8 Page: 198/241 Date: 27/10/2015
Long Term
Dermal, Local effects, Long Term 0.2 mg/cm2 0.2
Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (4)
PROC8a Batch loading of equipment (manual, non dedicated)
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (5)
PROC7 Spray coating- any technique
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.05 mg/m³ < 0.01
Inhalation, Systemic effects, Acute 0.2 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.05 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.2 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
0.107 mg/kg bw/day 0.054
Dermal, Local effects, Long Term 0.005 mg/cm2 < 0.01
Combined routes, Systemic effects, Long Term
- 0.063
200/243
![Page 201: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/201.jpg)
Malic Acid
Revision: 8 Page: 199/241 Date: 27/10/2015
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (6)
PROC10 Brushing, roller, spreader, flow coating or printing- any technique
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.372 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.78
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (7)
PROC13 Treatment of articles by dipping and pouring
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.1 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.4 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.2 mg/cm2 0.2
Combined routes, Systemic effects, Long Term
- 0.704
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (8)
PROC2 Curing and drying processes after application- elevated temperature 201/243
![Page 202: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/202.jpg)
Malic Acid
Revision: 8 Page: 200/241 Date: 27/10/2015
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.01 mg/m³ < 0.01
Inhalation, Systemic effects, Acute 0.04 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.01 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.04 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
0.137 mg/kg bw/day 0.068
Dermal, Local effects, Long Term 0.02 mg/cm2 0.02
Combined routes, Systemic effects, Long Term
- 0.07
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (9)
PROC8a Manual cleaning and maintenance of equipment
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
202/243
![Page 203: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/203.jpg)
Malic Acid
Revision: 8 Page: 201/241 Date: 27/10/2015
Section 4: Guidance to DU to evaluate whether he works inside the boundaries set by the ES
No additional risk management measures, besides those that are mentioned above, are needed to guarantee safe use for workers. Exposure Scenario 21: Industrial use of Metal Treatment Products
Section 1: Title of exposure scenario
Chemical product category [PC] PC9a Coatings and paints, thinners, paint removers PC14 Metal surface treatment products, including galvanic and electroplating products PC18 Ink and toners
Contributing scenario controlling environmental exposure
ERC5 Industrial use of Metal Treatment Products
Contributing scenario controlling worker exposure
PROC2 Application of metal surface treatment in closed systems with occasional exposure PROC8a Batch loading of equipment (manual, non dedicated) PROC8b Raw material receipt and transfer PROC13 Treatment of articles by dipping and pouring PROC8a Manual cleaning and maintenance of equipment
Section 2: Operational conditions of use
Contributing scenario controlling environmental exposure (1)
ERC5 Industrial use of Metal Treatment Products
Amounts used, Frequency and duration of use
Daily use at site ≤ 0.05 tonnes/day
Annual use at site ≤ 150 tonnes/year
Percentage of tonnage used at regional scale
100%
Conditions and measures related to municipal sewage treatment plant
Municipal STP Yes. [Effectiveness - Water: 87.34%]
Discharge rate of STP ≥ 2 X 103 m3/days
Application of the STP sludge on agricultural soil
Yes
Conditions and measures related to external treatment of waste for disposal
Particular considerations on the waste treatment operations: No (low risk) (ERC based assessment demonstrating control of risk with default conditions. Low risk assumed for waste life stage. Waste disposal according to national/local legislation is sufficient.)
Other given operational conditions affecting environmental exposure
Receiving surface water flow ≥ 1.8 X 104 m3/days
Chemical waste - discontinuous generation
Spent process fluid to be disposed of as chemical waste
Chemical waste - continuous generation
Spent fluid discharged to wastewater 203/243
![Page 204: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/204.jpg)
Malic Acid
Revision: 8 Page: 202/241 Date: 27/10/2015
On site treatment of wastewater pH adjustment and subsequent filtration/sedimentation - Ni salts [Effectiveness - Water: 95%]
Contributing scenario controlling worker exposure (1)
PROC2 Application of metal surface treatment in closed systems with occasional exposure
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Closed continuous process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (2)
PROC8a Batch loading of equipment (manual, non dedicated)
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No. 204/243
![Page 205: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/205.jpg)
Malic Acid
Revision: 8 Page: 203/241 Date: 27/10/2015
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (3)
PROC8b Raw material receipt and transfer
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
5-25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
205/243
![Page 206: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/206.jpg)
Malic Acid
Revision: 8 Page: 204/241 Date: 27/10/2015
Contributing scenario controlling worker exposure (4)
PROC13 Treatment of articles by dipping and pouring
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (5)
PROC8a Manual cleaning and maintenance of equipment
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No. 206/243
![Page 207: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/207.jpg)
Malic Acid
Revision: 8 Page: 205/241 Date: 27/10/2015
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Section 3: Exposure estimation and reference to its source
Contributing scenario controlling environmental exposure (1)
ERC5 Industrial use of Metal Treatment Products
Release route Release rate Release estimation method
Water 0.125 kg/day SpERC based
Air 0 kg/day SpERC based
Soil 0 kg/day SpERC based
Protection target Exposure estimation Risk characterisation ratio
Fresh water 0.001 mg/L 0.011
Sea water 1.043 X 10-4 mg/L 0.01
Sewage treatment plant 0.008 mg/L < 0.01
Man via Environment - Inhalation 2.918 X 10-11 mg/m³ < 0.01
Man via Environment - Oral 2.246 X 10-4 mg/kg bw/day < 0.01
Contributing scenario controlling worker exposure (1)
PROC2 Application of metal surface treatment in closed systems with occasional exposure
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.01 mg/m³ < 0.01
Inhalation, Systemic effects, Acute 0.04 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.01 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.04 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
0.137 mg/kg bw/day 0.068
207/243
![Page 208: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/208.jpg)
Malic Acid
Revision: 8 Page: 206/241 Date: 27/10/2015
Dermal, Local effects, Long Term 0.02 mg/cm2 0.02
Combined routes, Systemic effects, Long Term
- 0.07
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (2)
PROC8a Batch loading of equipment (manual, non dedicated)
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (3)
PROC8b Raw material receipt and transfer
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.06 mg/m³ 0.011
Inhalation, Systemic effects, Acute 0.24 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.06 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.24 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
0.823 mg/kg bw/day 0.411
Dermal, Local effects, Long Term 0.06 mg/cm2 0.06
Combined routes, Systemic effects, Long Term
- 0.423
Combined routes, Systemic effects, Acute
- < 0.01 208/243
![Page 209: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/209.jpg)
Malic Acid
Revision: 8 Page: 207/241 Date: 27/10/2015
Contributing scenario controlling worker exposure (4)
PROC13 Treatment of articles by dipping and pouring
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.1 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.4 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.2 mg/cm2 0.2
Combined routes, Systemic effects, Long Term
- 0.704
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (5)
PROC8a Manual cleaning and maintenance of equipment
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
209/243
![Page 210: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/210.jpg)
Malic Acid
Revision: 8 Page: 208/241 Date: 27/10/2015
Section 4: Guidance to DU to evaluate whether he works inside the boundaries set by the ES
No additional risk management measures, besides those that are mentioned above, are needed to guarantee safe use for workers. Exposure Scenario 22: Professional painting and coatings
Section 1: Title of exposure scenario
Chemical product category [PC] PC9a Coatings and paints, thinners, paint removers PC14 Metal surface treatment products, including galvanic and electroplating products PC18 Ink and toners
Sectors of use [SU] SU15 Manufacture of fabricated metal products, except machinery and equipment SU17 General manufacturing, e.g. machinery, equipment, vehicles, other transport equipment SU19 Building and construction work SU0 Other
Contributing scenario controlling environmental exposure
ERC8f, ERC8c Use leading to inclusion into/onto matrix
Contributing scenario controlling worker exposure
PROC8a Transfer in non-dedicated facilities PROC10 Roller application or brushing PROC11 Non industrial spraying
Subsequent service life exposure scenario(s)
ES 25 Service life (professional worker); Service life articles used by workers; SU 5; SU 6b; SU 11; SU 12; SU 13; SU 16; SU 17; SU 18; SU 19; SU 0
ES 26 Service life (consumers); Service life articles used by consumers
Section 2: Operational conditions of use
Contributing scenario controlling environmental exposure (1)
ERC8f Use leading to inclusion into/onto matrix
Amounts used, Frequency and duration of use
Daily wide dispersive use ≤ 5.5 X 10-6 tonnes/day
Percentage of tonnage used at regional scale
10%
Conditions and measures related to municipal sewage treatment plant
Municipal STP Yes. [Effectiveness - Water: 87.34%]
Discharge rate of STP ≥ 2 X 103 m3/days
Application of the STP sludge on agricultural soil
Yes
Conditions and measures related to external treatment of waste for disposal
Particular considerations on the waste treatment operations: No (low risk) (ERC based assessment demonstrating control of risk with default conditions. Low risk assumed for waste life stage. Waste disposal according to national/local legislation is sufficient.)
Other given operational conditions affecting environmental exposure
Receiving surface water flow ≥ 1.8 X 104 m3/days 210/243
![Page 211: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/211.jpg)
Malic Acid
Revision: 8 Page: 209/241 Date: 27/10/2015
Contributing scenario controlling worker exposure (1)
PROC8a Transfer in non-dedicated facilities
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
5-25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Basic
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (2)
PROC10 Roller application or brushing
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
5-25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <4 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%] 211/243
![Page 212: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/212.jpg)
Malic Acid
Revision: 8 Page: 210/241 Date: 27/10/2015
Occupational Health and Safety Management System
Basic
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (3)
PROC11 Non industrial spraying
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
5-25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <1 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Basic
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands and upper wrists (1500 cm2)
Section 3: Exposure estimation and reference to its source
Contributing scenario controlling environmental exposure (1)
ERC8f Use leading to inclusion into/onto matrix
212/243
![Page 213: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/213.jpg)
Malic Acid
Revision: 8 Page: 211/241 Date: 27/10/2015
Release route Release rate Release estimation method
Water 5.5 X 10-4 kg/day ERC based
Air 0.008 kg/day ERC based
Soil 2.75 X 10-4 kg/day ERC based
Protection target Exposure estimation Risk characterisation ratio
Fresh water 2.675 X 10-4 mg/L < 0.01
Sea water 2.556 X 10-5 mg/L < 0.01
Sewage treatment plant 3.481 X 10-5 mg/L < 0.01
Man via Environment - Inhalation 2.912 X 10-11 mg/m³ < 0.01
Man via Environment - Oral 7.286 X 10-5 mg/kg bw/day < 0.01
Contributing scenario controlling worker exposure (1)
PROC8a Transfer in non-dedicated facilities
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.3 mg/m³ 0.056
Inhalation, Systemic effects, Acute 1.2 mg/m³ 0.012
Inhalation, Local effects, Long Term
0.3 mg/m³ < 0.01
Inhalation, Local effects, Acute 1.2 mg/m³ 0.012
Dermal, Systemic effects, Long Term
0.823 mg/kg bw/day 0.411
Dermal, Local effects, Long Term 0.06 mg/cm2 0.06
Combined routes, Systemic effects, Long Term
- 0.468
Combined routes, Systemic effects, Acute
- 0.012
Contributing scenario controlling worker exposure (2)
PROC10 Roller application or brushing
Method: TRA Worker v3
213/243
![Page 214: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/214.jpg)
Malic Acid
Revision: 8 Page: 212/241 Date: 27/10/2015
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.18 mg/m³ 0.034
Inhalation, Systemic effects, Acute 1.2 mg/m³ 0.012
Inhalation, Local effects, Long Term
0.18 mg/m³ < 0.01
Inhalation, Local effects, Acute 1.2 mg/m³ 0.012
Dermal, Systemic effects, Long Term
0.988 mg/kg bw/day 0.494
Dermal, Local effects, Long Term 0.072 mg/cm2 0.072
Combined routes, Systemic effects, Long Term
- 0.528
Combined routes, Systemic effects, Acute
- 0.012
Contributing scenario controlling worker exposure (3)
PROC11 Non industrial spraying
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.12 mg/m³ 0.023
Inhalation, Systemic effects, Acute 2.4 mg/m³ 0.023
Inhalation, Local effects, Long Term
0.12 mg/m³ < 0.01
Inhalation, Local effects, Acute 2.4 mg/m³ 0.023
Dermal, Systemic effects, Long Term
1.286 mg/kg bw/day 0.643
Dermal, Local effects, Long Term 0.06 mg/cm2 0.06
Combined routes, Systemic effects, Long Term
- 0.665
Combined routes, Systemic effects, Acute
- 0.023
Section 4: Guidance to DU to evaluate whether he works inside the boundaries set by the ES
No additional risk management measures, besides those that are mentioned above, are needed to guarantee safe use for workers.
214/243
![Page 215: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/215.jpg)
Malic Acid
Revision: 8 Page: 213/241 Date: 27/10/2015
Exposure Scenario 23: Consumer painting and coatings
Section 1: Title of exposure scenario
Chemical product category [PC] PC9a Coatings and paints, thinners, paint removers PC14 Metal surface treatment products, including galvanic and electroplating products PC18 Ink and toners
Contributing scenario controlling environmental exposure
ERC8f, ERC8c Use leading to inclusion into/onto matrix
Contributing scenario controlling consumer exposure
PC9a Use in water born wall paints, roller and brush application PC9a Use in rich solvent paints, roller and brush application PC14 Metal surface treatments (general) PC38 Welding and Flux products
Subsequent service life exposure scenario(s)
ES 25 Service life (professional worker); Service life articles used by workers; SU 5; SU 6b; SU 11; SU 12; SU 13; SU 16; SU 17; SU 18; SU 19; SU 0
ES 26 Service life (consumers); Service life articles used by consumers
Section 2: Operational conditions of use
Contributing scenario controlling environmental exposure (1)
ERC8f Use leading to inclusion into/onto matrix
Amounts used, Frequency and duration of use
Daily wide dispersive use ≤ 2.75 X 10-5 tonnes/day
Percentage of tonnage used at regional scale
10%
Conditions and measures related to municipal sewage treatment plant
Municipal STP Yes. [Effectiveness - Water: 87.34%]
Discharge rate of STP ≥ 2 X 103 m3/days
Application of the STP sludge on agricultural soil
Yes
Conditions and measures related to external treatment of waste for disposal
Particular considerations on the waste treatment operations: No (low risk) (ERC based assessment demonstrating control of risk with default conditions. Low risk assumed for waste life stage. Waste disposal according to national/local legislation is sufficient.)
Other given operational conditions affecting environmental exposure
Receiving surface water flow ≥ 1.8 X 104 m3/days
Contributing scenario controlling consumer exposure (1)
PC9a Use in water born wall paints, roller and brush application
Product (article) characteristic
Product/ Article subcategory Solvent rich, high solid, water borne paint
Spray No. Concentration of substance in mixture
0.05 g/g
Oral contact foreseen No. 215/243
![Page 216: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/216.jpg)
Malic Acid
Revision: 8 Page: 214/241 Date: 27/10/2015
Amounts used, Frequency and duration of use
Amount of product used per application
1.3 X 103 g/event
Exposure time 2.2 hour(s)
Frequency of use 1 event/day
Other conditions affecting consumers exposure
Body parts potentially exposed Inside hands / one hand / palm of hands
Dermal transfer factor 1
Contributing scenario controlling consumer exposure (2)
PC9a Use in rich solvent paints, roller and brush application
Product (article) characteristic
Product/ Article subcategory Solvent rich, high solid, water borne paint
Spray No. Concentration of substance in mixture
0.05 g/g
Oral contact foreseen No.
Amounts used, Frequency and duration of use
Amount of product used per application
1 X 103 g/event
Exposure time 2.2 hour(s)
Frequency of use 1 event/day
Other conditions affecting consumers exposure
Body parts potentially exposed Inside hands / one hand / palm of hands
Dermal transfer factor 1
Contributing scenario controlling consumer exposure (3)
PC14 Metal surface treatments (general)
Product (article) characteristic
Product/ Article subcategory No value
Contributing scenario controlling consumer exposure (4)
PC38 Welding and Flux products
Product (article) characteristic
Product/ Article subcategory No value
Section 3: Exposure estimation and reference to its source
Contributing scenario controlling environmental exposure (1)
ERC8f Use leading to inclusion into/onto matrix
Release route Release rate Release estimation method
Water 2.75 X 10-4 kg/day ERC based
Air 0.004 kg/day ERC based
Soil 1.375 X 10-4 kg/day ERC based 216/243
![Page 217: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/217.jpg)
Malic Acid
Revision: 8 Page: 215/241 Date: 27/10/2015
Protection target Exposure estimation Risk characterisation ratio
Fresh water 2.657 X 10-4 mg/L <0.01 Sea water 2.538 X 10-5 mg/L <0.01 Sewage treatment plant 1.74 X 10-5 mg/L <0.01 Man via Environment - Inhalation 2.912 X 10-11 mg/m³ <0.01 Man via Environment - Oral 7.285 X 10-5 mg/kg bw/day <0.01 Contributing scenario controlling consumer exposure (1)
PC9a Use in water born wall paints, roller and brush application
Method: TRA Consumer v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.022 mg/m³ 0.014
Inhalation, Local effects, Long Term
0.022 mg/m³ 0.014
Dermal, Systemic effects, Long Term
3.573 mg/kg bw/day 0.596
Oral, Systemic effects, Long Term
0 mg/kg bw/day < 0.01
Combined routes, Systemic effects, Long Term
- 0.609
Contributing scenario controlling consumer exposure (2)
PC9a Use in rich solvent paints, roller and brush application
Method: TRA Consumer v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.022 mg/m³ 0.014
Inhalation, Local effects, Long Term
0.022 mg/m³ 0.014
Dermal, Systemic effects, Long Term
3.573 mg/kg bw/day 0.596
Oral, Systemic effects, Long Term
0 mg/kg bw/day < 0.01
Combined routes, Systemic effects, Long Term
- 0.609
Contributing scenario controlling consumer exposure (3)
PC14 Metal surface treatments (general)
Not available
Contributing scenario controlling consumer exposure (4) 217/243
![Page 218: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/218.jpg)
Malic Acid
Revision: 8 Page: 216/241 Date: 27/10/2015
PC38 Welding and Flux products
Not available
Section 4: Guidance to DU to evaluate whether he works inside the boundaries set by the ES
No additional risk management measures, besides those that are mentioned above, are needed to guarantee safe use for workers.
Exposure Scenario 24: General industrial use in production of polymers and resins
Section 1: Title of exposure scenario
Chemical product category [PC] PC32 Polymer preparations and compounds
Sectors of use [SU] SU11 Manufacture of rubber products SU12 Manufacture of plastics products, including compounding and conversion
Contributing scenario controlling environmental exposure
ERC5 General industrial use in production of polymers and resins
Contributing scenario controlling worker exposure
PROC8b Raw material receipt and transfer PROC5 Preparation of polymers and resins PROC14 Polymer compounding PROC24 Polymer compounding (high energy) PROC8a Batch loading of equipment (manual, non dedicated) PROC8a Manual cleaning and maintenance of equipment
Subsequent service life exposure scenario(s)
ES 25 Service life (professional worker); Service life articles used by workers; SU 5; SU 6b; SU 11; SU 12; SU 13; SU 16; SU 17; SU 18; SU 19; SU 0
ES 26 Service life (consumers); Service life articles used by consumers
Section 2: Operational conditions of use
Contributing scenario controlling environmental exposure (1)
ERC5 General industrial use in production of polymers and resins
Amounts used, Frequency and duration of use
Daily use at site ≤ 0.7 tonnes/day
Annual use at site ≤ 150 tonnes/year
Percentage of tonnage used at regional scale
10%
Conditions and measures related to municipal sewage treatment plant
Municipal STP Yes. [Effectiveness - Water: 87.34%]
Discharge rate of STP ≥ 2 X 103 m3/days
Application of the STP sludge on agricultural soil
Yes
Conditions and measures related to external treatment of waste for disposal
Particular considerations on the waste treatment operations: No (low risk) (ERC based assessment demonstrating control of risk with default conditions. Low risk assumed for waste life stage. Waste disposal according to national/local legislation is sufficient.)
Other given operational conditions affecting environmental exposure 218/243
![Page 219: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/219.jpg)
Malic Acid
Revision: 8 Page: 217/241 Date: 27/10/2015
Receiving surface water flow ≥ 1.8 X 104 m3/days
Contributing scenario controlling worker exposure (1)
PROC8b Raw material receipt and transfer
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (2)
PROC5 Preparation of polymers and resins
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced 219/243
![Page 220: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/220.jpg)
Malic Acid
Revision: 8 Page: 218/241 Date: 27/10/2015
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (3)
PROC14 Polymer compounding
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (4)
PROC24 Polymer compounding (high energy)
Product (article) characteristic
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use 220/243
![Page 221: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/221.jpg)
Malic Acid
Revision: 8 Page: 219/241 Date: 27/10/2015
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation Yes [Effectiveness - Inhalation: 80%]
Local exhaust ventilation (Dermal) No. [Effectiveness - Dermal: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Elevated temperature > melting point
Skin surface potentially exposed Two hands and forearms (1980 cm2)
Contributing scenario controlling worker exposure (5)
PROC8a Batch loading of equipment (manual, non dedicated)
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use 221/243
![Page 222: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/222.jpg)
Malic Acid
Revision: 8 Page: 220/241 Date: 27/10/2015
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (6)
PROC8a Manual cleaning and maintenance of equipment
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Advanced
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Section 3: Exposure estimation and reference to its source
Contributing scenario controlling environmental exposure (1)
ERC5 General industrial use in production of polymers and resins
Release route Release rate Release estimation method
Water 14 kg/day Release factor
Air 0.7 kg/day Release factor
Soil 7 kg/day ERC based
Protection target Exposure estimation Risk characterisation ratio
Fresh water 0.089 mg/L 0.889
Sea water 0.009 mg/L 0.889
Sewage treatment plant 0.886 mg/L 0.295
Man via Environment - Inhalation 1.142 X 10-4 mg/m³ < 0.01 222/243
![Page 223: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/223.jpg)
Malic Acid
Revision: 8 Page: 221/241 Date: 27/10/2015
Man via Environment - Oral 0.018 mg/kg bw/day < 0.01
Contributing scenario controlling worker exposure (1)
PROC8b Raw material receipt and transfer
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.1 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.4 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.704
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (2)
PROC5 Preparation of polymers and resins
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.2 mg/cm2 0.2
Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (3)
PROC14 Polymer compounding
Method: TRA Worker v3 223/243
![Page 224: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/224.jpg)
Malic Acid
Revision: 8 Page: 222/241 Date: 27/10/2015
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.1 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.4 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
0.343 mg/kg bw/day 0.172
Dermal, Local effects, Long Term 0.05 mg/cm2 0.05
Combined routes, Systemic effects, Long Term
- 0.19
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (4)
PROC24 Polymer compounding (high energy)
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
2 mg/m³ 0.375
Inhalation, Systemic effects, Acute 8 mg/m³ 0.077
Inhalation, Local effects, Long Term
2 mg/m³ 0.062
Inhalation, Local effects, Acute 8 mg/m³ 0.077
Dermal, Systemic effects, Long Term
0.283 mg/kg bw/day 0.142
Dermal, Local effects, Long Term 0.01 mg/cm2 0.01
Combined routes, Systemic effects, Long Term
- 0.517
Combined routes, Systemic effects, Acute
- 0.077
Contributing scenario controlling worker exposure (5)
PROC8a Batch loading of equipment (manual, non dedicated)
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019 224/243
![Page 225: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/225.jpg)
Malic Acid
Revision: 8 Page: 223/241 Date: 27/10/2015
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (6)
PROC8a Manual cleaning and maintenance of equipment
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
Section 4: Guidance to DU to evaluate whether he works inside the boundaries set by the ES
No additional risk management measures, besides those that are mentioned above, are needed to guarantee safe use for workers. Exposure Scenario 25: Professional use of resins
Section 1: Title of exposure scenario
Chemical product category [PC] PC32 Polymer preparations and compounds
Sectors of use [SU] SU10 Formulation [mixing] of preparations and/or re-packaging (excluding alloys) SU11 Manufacture of rubber products SU12 Manufacture of plastics products, including compounding and conversion SU19 Building and construction work
Contributing scenario controlling environmental exposure
ERC8f, ERC8c Professional use of resins
Contributing scenario controlling PROC8a Transfer in non-dedicated facilities 225/243
![Page 226: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/226.jpg)
Malic Acid
Revision: 8 Page: 224/241 Date: 27/10/2015
worker exposure PROC5 Mixing (general) PROC11 Non industrial spraying PROC10 Roller application or brushing
Subsequent service life exposure scenario(s)
ES 25 Service life (professional worker); Service life articles used by workers; SU 5; SU 6b; SU 11; SU 12; SU 13; SU 16; SU 17; SU 18; SU 19; SU 0
ES 26 Service life (consumers); Service life articles used by consumers
Section 2: Operational conditions of use
Contributing scenario controlling environmental exposure (1)
ERC8f Professional use of resins
Amounts used, Frequency and duration of use
Daily wide dispersive use ≤ 5.5 X 10-5 tonnes/day
Percentage of tonnage used at regional scale
10%
Conditions and measures related to municipal sewage treatment plant
Municipal STP Yes. [Effectiveness - Water: 87.34%]
Discharge rate of STP ≥ 2 X 103 m3/days
Application of the STP sludge on agricultural soil
Yes
Conditions and measures related to external treatment of waste for disposal
Particular considerations on the waste treatment operations: No (low risk) (ERC based assessment demonstrating control of risk with default conditions. Low risk assumed for waste life stage. Waste disposal according to national/local legislation is sufficient.)
Other given operational conditions affecting environmental exposure
Receiving surface water flow ≥ 1.8 X 104 m3/days
Contributing scenario controlling worker exposure (1)
PROC8a Transfer in non-dedicated facilities
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Basic 226/243
![Page 227: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/227.jpg)
Malic Acid
Revision: 8 Page: 225/241 Date: 27/10/2015
Management System
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Contributing scenario controlling worker exposure (2)
PROC5 Mixing (general)
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
>25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Basic
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (3)
PROC11 Non industrial spraying
Product (article) characteristic
Dustiness of material Low 227/243
![Page 228: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/228.jpg)
Malic Acid
Revision: 8 Page: 226/241 Date: 27/10/2015
Concentration of substance in mixture
5-25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <1 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Basic
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands and upper wrists (1500 cm2)
Contributing scenario controlling worker exposure (4)
PROC10 Roller application or brushing
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
5-25%
Solid in solid mixtures Yes
Amounts used, Frequency and duration of use
Duration of activity <4 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Basic
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%] 228/243
![Page 229: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/229.jpg)
Malic Acid
Revision: 8 Page: 227/241 Date: 27/10/2015
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Section 3: Exposure estimation and reference to its source
Contributing scenario controlling environmental exposure (1)
ERC8f Professional use of resins
Release route Release rate Release estimation method
Water 5.5 X 10-4 kg/day ERC based
Air 0.008 kg/day ERC based
Soil 2.75 X 10-4 kg/day ERC based
Protection target Exposure estimation Risk characterisation ratio
Fresh water 2.675 X 10-4 mg/L < 0.01
Sea water 2.556 X 10-5 mg/L < 0.01
Sewage treatment plant 3.481 X 10-5 mg/L < 0.01
Man via Environment - Inhalation 2.912 X 10-11 mg/m³ < 0.01
Man via Environment - Oral 7.286 X 10-5 mg/kg bw/day < 0.01
Contributing scenario controlling worker exposure (1)
PROC8a Transfer in non-dedicated facilities
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic effects, Acute
- 0.019
229/243
![Page 230: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/230.jpg)
Malic Acid
Revision: 8 Page: 228/241 Date: 27/10/2015
Contributing scenario controlling worker exposure (2)
PROC5 Mixing (general)
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
1 mg/m³ 0.188
Inhalation, Systemic effects, Acute 4 mg/m³ 0.038
Inhalation, Local effects, Long Term
1 mg/m³ 0.031
Inhalation, Local effects, Acute 4 mg/m³ 0.038
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.2 mg/cm2 0.2
Combined routes, Systemic effects, Long Term
- 0.873
Combined routes, Systemic effects, Acute
- 0.038
Contributing scenario controlling worker exposure (3)
PROC11 Non industrial spraying
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.12 mg/m³ 0.023
Inhalation, Systemic effects, Acute 2.4 mg/m³ 0.023
Inhalation, Local effects, Long Term
0.12 mg/m³ < 0.01
Inhalation, Local effects, Acute 2.4 mg/m³ 0.023
Dermal, Systemic effects, Long Term
1.286 mg/kg bw/day 0.643
Dermal, Local effects, Long Term 0.06 mg/cm2 0.06
Combined routes, Systemic effects, Long Term
- 0.665
Combined routes, Systemic effects, Acute
- 0.023
Contributing scenario controlling worker exposure (4)
PROC10 Roller application or brushing
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
230/243
![Page 231: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/231.jpg)
Malic Acid
Revision: 8 Page: 229/241 Date: 27/10/2015
Inhalation, Systemic effects, Long Term
0.18 mg/m³ 0.034
Inhalation, Systemic effects, Acute 1.2 mg/m³ 0.012
Inhalation, Local effects, Long Term
0.18 mg/m³ < 0.01
Inhalation, Local effects, Acute 1.2 mg/m³ 0.012
Dermal, Systemic effects, Long Term
0.988 mg/kg bw/day 0.494
Dermal, Local effects, Long Term 0.072 mg/cm2 0.072
Combined routes, Systemic effects, Long Term
- 0.528
Combined routes, Systemic effects, Acute
- 0.012
Section 4: Guidance to DU to evaluate whether he works inside the boundaries set by the ES
No additional risk management measures, besides those that are mentioned above, are needed to guarantee safe use for workers. Exposure Scenario 26: Consumer resin use
Section 1: Title of exposure scenario
Chemical product category [PC] PC32 Polymer preparations and compounds
Contributing scenario controlling environmental exposure
ERC8f, ERC8c Consumer resin use
Contributing scenario controlling consumer exposure
PC32 Use of resins PC1 Adhesives, sealants
Subsequent service life exposure scenario(s)
ES 25 Service life (professional worker); Service life articles used by workers; SU 5; SU 6b; SU 11; SU 12; SU 13; SU 16; SU 17; SU 18; SU 19; SU 0
ES 26 Service life (consumers); Service life articles used by consumers
Section 2: Operational conditions of use
Contributing scenario controlling environmental exposure (1)
ERC8f Consumer resin use
Amounts used, Frequency and duration of use
Daily wide dispersive use ≤ 2.75 X 10-5 tonnes/day
Percentage of tonnage used at regional scale
10%
Conditions and measures related to municipal sewage treatment plant
Municipal STP Yes. [Effectiveness - Water: 87.34%]
Discharge rate of STP ≥ 2 X 103 m3/days
Application of the STP sludge on agricultural soil
Yes
Conditions and measures related to external treatment of waste for disposal 231/243
![Page 232: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/232.jpg)
Malic Acid
Revision: 8 Page: 230/241 Date: 27/10/2015
Particular considerations on the waste treatment operations: No (low risk) (ERC based assessment demonstrating control of risk with default conditions. Low risk assumed for waste life stage. Waste disposal according to national/local legislation is sufficient.)
Other given operational conditions affecting environmental exposure
Receiving surface water flow ≥ 1.8 X 104 m3/days
Contributing scenario controlling consumer exposure (1)
PC32 Use of resins
Product (article) characteristic
Product/ Article subcategory No value
Contributing scenario controlling consumer exposure (2)
PC1 Adhesives, sealants
Product (article) characteristic
Product/ Article subcategory Glues DIY-use (carpet glue, tile glue, wood parquet glue)
Concentration of substance in mixture
0.05 g/g
Oral contact foreseen No.
Amounts used, Frequency and duration of use
Amount of product used per application
10 g/event
Exposure time 6 hour(s)
Frequency of use 1 event/day
Other conditions affecting consumers exposure
Body parts potentially exposed Inside hands / one hand / palm of hands
Dermal transfer factor 1
Section 3: Exposure estimation and reference to its source
Contributing scenario controlling environmental exposure (1)
ERC8f Consumer resin use
Release route Release rate Release estimation method
Water 2.75 X 10-4 kg/day ERC based
Air 0.004 kg/day ERC based
Soil 1.375 X 10-4 kg/day ERC based
Protection target Exposure estimation Risk characterisation ratio
Fresh water 2.657 X 10-4 mg/L <0.01 Sea water 2.538 X 10-5 mg/L <0.01 Sewage treatment plant 1.74 X 10-5 mg/L <0.01 Man via Environment - Inhalation 2.912 X 10-11 mg/m³ <0.01 Man via Environment - Oral 7.285 X 10-5 mg/kg bw/day <0.01 Contributing scenario controlling consumer exposure (1) 232/243
![Page 233: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/233.jpg)
Malic Acid
Revision: 8 Page: 231/241 Date: 27/10/2015
PC32 Use of resins
Not available
Contributing scenario controlling consumer exposure (1)
PC1 Adhesives, sealants
Method: TRA Consumer v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.005 mg/m³ 0.014
Inhalation, Local effects, Long Term
0.005 mg/m³ 0.014
Dermal, Systemic effects, Long Term
3.573 mg/kg bw/day 0.596
Oral, Systemic effects, Long Term
0 mg/kg bw/day < 0.01
Combined routes, Systemic effects, Long Term
- 0.609
Section 4: Guidance to DU to evaluate whether he works inside the boundaries set by the ES
No additional risk management measures, besides those that are mentioned above, are needed to guarantee safe use for workers. Exposure Scenario 27: Laboratory use (professional worker)
Section 1: Title of exposure scenario
Chemical product category [PC] PC20 Products such as ph-regulators, flocculants, precipitants, neutralization agents PC21 Laboratory chemicals
Sectors of use [SU] SU5 Manufacture of textiles, leather, fur SU6b Manufacture of pulp, paper and paper products SU11 Manufacture of rubber products SU12 Manufacture of plastics products, including compounding and conversion SU13 Manufacture of other non-metallic mineral products, e.g. plasters, cement SU17 General manufacturing, e.g. machinery, equipment, vehicles, other transport equipment SU19 Building and construction work SU24 Scientific research and development
Contributing scenario controlling environmental exposure
ERC8e, ERC8b Laboratory use (professional worker)
Contributing scenario controlling worker exposure
PROC4 Use in batch and other process (synthesis) where opportunity for exposure arises PROC2 Use in closed, continuous process with occasional controlled exposure PROC9 Transfer of substance or preparations in small containers PROC15 Use as laboratory reagent PROC8a Maintenance and cleaning operations
Section 2: Operational conditions of use 233/243
![Page 234: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/234.jpg)
Malic Acid
Revision: 8 Page: 232/241 Date: 27/10/2015
Contributing scenario controlling environmental exposure (1)
ERC8e Laboratory use (professional worker)
Amounts used, Frequency and duration of use
Daily wide dispersive use ≤ 5.5 X 10-7 tonnes/day
Percentage of tonnage used at regional scale
10%
Conditions and measures related to municipal sewage treatment plant
Municipal STP Yes. [Effectiveness - Water: 87.34%]
Discharge rate of STP ≥ 2 X 103 m3/days
Application of the STP sludge on agricultural soil
Yes
Conditions and measures related to external treatment of waste for disposal
Particular considerations on the waste treatment operations: No (low risk) (ERC based assessment demonstrating control of risk with default conditions. Low risk assumed for waste life stage. Waste disposal according to national/local legislation is sufficient.)
Other given operational conditions affecting environmental exposure
Receiving surface water flow ≥ 1.8 X 104 m3/days
Contributing scenario controlling worker exposure (1)
PROC4 Use in batch and other process (synthesis) where opportunity for exposure arises
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Basic
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient 234/243
![Page 235: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/235.jpg)
Malic Acid
Revision: 8 Page: 233/241 Date: 27/10/2015
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (2)
PROC2 Use in closed, continuous process with occasional controlled exposure
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Closed continuous process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Basic
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (3)
PROC9 Transfer of substance or preparations in small containers
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment Semi-closed process with occasional controlled exposure
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Basic 235/243
![Page 236: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/236.jpg)
Malic Acid
Revision: 8 Page: 234/241 Date: 27/10/2015
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands face (480 cm2)
Contributing scenario controlling worker exposure (4)
PROC15 Use as laboratory reagent
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Basic
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed One hand face only (240 cm2)
Contributing scenario controlling worker exposure (5)
PROC8a Maintenance and cleaning operations
Product (article) characteristic
Dustiness of material Low
Concentration of substance in mixture
Substance as such
236/243
![Page 237: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/237.jpg)
Malic Acid
Revision: 8 Page: 235/241 Date: 27/10/2015
Amounts used, Frequency and duration of use
Duration of activity <8 hour(s)
Technical conditions and measures to control dispersion from source towards the worker
General ventilation Basic general ventilation (1-3 air changes per hour)
Containment No.
Local exhaust ventilation No. [Effectiveness - Inhalation: 0%]
Occupational Health and Safety Management System
Basic
Conditions and measures related to personal protection, hygiene and health evaluation
Hand protection/ Skin protection Wear impervious gloves (EN374). [Effectiveness - Dermal: 90%]
Respiratory protection No. [Effectiveness - Inhalation: 0%]
Eye Protection Safety spectacles/goggles/full face shield
Other given operational conditions affecting workers exposure
Place of use Indoor use
Process temperature (for solid) Ambient
Skin surface potentially exposed Two hands (960 cm2)
Section 3: Exposure estimation and reference to its source
Contributing scenario controlling environmental exposure (1)
ERC8e Laboratory use (professional worker)
Release route Release rate Release estimation method
Water 1.1 X 10-5 kg/day ERC based
Air 5.5 X 10-7 kg/day ERC based
Soil 5.5 X 10-6 kg/day ERC based
Protection target Exposure estimation Risk characterisation ratio
Fresh water 2.641 X 10-4 mg/L <0.01 Sea water 2.522 X 10-5 mg/L <0.01 Sewage treatment plant 6.961 X 10-7 mg/L <0.01 Man via Environment - Inhalation 2.912 X 10-11 mg/m³ <0.01 Man via Environment - Oral 7.285 X 10-5 mg/kg bw/day <0.01 Contributing scenario controlling worker exposure (1)
PROC4 Use in batch and other process (synthesis) where opportunity for exposure arises
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
1 mg/m³ 0.188
237/243
![Page 238: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/238.jpg)
Malic Acid
Revision: 8 Page: 236/241 Date: 27/10/2015
Inhalation, Systemic effects, Acute 4 mg/m³ 0.038
Inhalation, Local effects, Long Term
1 mg/m³ 0.031
Inhalation, Local effects, Acute 4 mg/m³ 0.038
Dermal, Systemic effects, Long Term
0.686 mg/kg bw/day 0.343
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.531
Combined routes, Systemic effects, Acute
- 0.038
Contributing scenario controlling worker exposure (2)
PROC2 Use in closed, continuous process with occasional controlled exposure
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.01 mg/m³ < 0.01
Inhalation, Systemic effects, Acute 0.04 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.01 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.04 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
0.137 mg/kg bw/day 0.068
Dermal, Local effects, Long Term 0.02 mg/cm2 0.02
Combined routes, Systemic effects, Long Term
- 0.07
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (3)
PROC9 Transfer of substance or preparations in small containers
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, 0.686 mg/kg bw/day 0.343 238/243
![Page 239: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/239.jpg)
Malic Acid
Revision: 8 Page: 237/241 Date: 27/10/2015
Long Term
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.437
Combined routes, Systemic effects, Acute
- 0.019
Contributing scenario controlling worker exposure (4)
PROC15 Use as laboratory reagent
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.1 mg/m³ 0.019
Inhalation, Systemic effects, Acute 0.4 mg/m³ < 0.01
Inhalation, Local effects, Long Term
0.1 mg/m³ < 0.01
Inhalation, Local effects, Acute 0.4 mg/m³ < 0.01
Dermal, Systemic effects, Long Term
0.034 mg/kg bw/day 0.017
Dermal, Local effects, Long Term 0.01 mg/cm2 < 0.01
Combined routes, Systemic effects, Long Term
- 0.036
Combined routes, Systemic effects, Acute
- < 0.01
Contributing scenario controlling worker exposure (5)
PROC8a Maintenance and cleaning operations
Method: TRA Worker v3
Route of exposure and type of
effects Exposure concentration Risk characterisation ratio
Inhalation, Systemic effects, Long Term
0.5 mg/m³ 0.094
Inhalation, Systemic effects, Acute 2 mg/m³ 0.019
Inhalation, Local effects, Long Term
0.5 mg/m³ 0.016
Inhalation, Local effects, Acute 2 mg/m³ 0.019
Dermal, Systemic effects, Long Term
1.371 mg/kg bw/day 0.686
Dermal, Local effects, Long Term 0.1 mg/cm2 0.1
Combined routes, Systemic effects, Long Term
- 0.779
Combined routes, Systemic - 0.019 239/243
![Page 240: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/240.jpg)
Malic Acid
Revision: 8 Page: 238/241 Date: 27/10/2015
effects, Acute
Section 4: Guidance to DU to evaluate whether he works inside the boundaries set by the ES
No additional risk management measures, besides those that are mentioned above, are needed to guarantee safe use for workers. Exposure Scenario 28: Service life articles used by workers
Section 1: Title of exposure scenario
Sectors of use [SU] SU5 Manufacture of textiles, leather, fur SU6b Manufacture of pulp, paper and paper products SU11 Manufacture of rubber products SU12 Manufacture of plastics products, including compounding and conversion SU13 Manufacture of other non-metallic mineral products, e.g. plasters, cement SU16 Manufacture of computer, electronic and optical products, electrical equipment SU17 General manufacturing, e.g. machinery, equipment, vehicles, other transport equipment SU18 Manufacture of furniture SU19 Building and construction work SU0 Other
Article Categories [AC] AC1 Vehicles AC2 Machinery, mechanical appliances, electrical/electronic articles AC4 Stone, plaster, cement, glass and ceramic articles AC5 Fabrics, textiles and apparel AC6 Leather articles AC8 Paper articles AC10 Rubber articles AC13 Plastic articles AC0 Other Articles
Contributing scenario controlling environmental exposure
ERC10a, ERC11a Use in articles
Exposure scenario of the uses leading to the inclusion of the substance into the article
ES6: Consumer Use - Consumer water treatment and cleaning product use ES11: Use at industrial site - Use at industrial sites of dyestuffs and in textiles uses ES13: Use at industrial site - Use at industrial sites in construction products ES14: Use by professional worker - Professional creation of building materials and articles ES15: Consumer Use - Consumer building product use ES17: Use at industrial site - General Industrial use of coatings and inks ES19: Use by professional worker - Professional painting and coatings ES20: Consumer Use - Consumer painting and coatings ES21: Use at industrial site - General industrial use in production of polymers and resins ES22: Use by professional worker - Professional use of resins ES23: Consumer Use - Consumer resin use
Section 2: Operational conditions of use
Contributing scenario controlling environmental exposure (1)
ERC10a Use in articles 240/243
![Page 241: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/241.jpg)
Malic Acid
Revision: 8 Page: 239/241 Date: 27/10/2015
Amounts used, Frequency and duration of use
Daily wide dispersive use ≤ 5.5 X 10-4 tonnes/day
Percentage of tonnage used at regional scale
10%
Conditions and measures related to municipal sewage treatment plant
Municipal STP Yes. [Effectiveness - Water: 87.34%]
Discharge rate of STP ≥ 2 X 103 m3/days
Application of the STP sludge on agricultural soil
Yes
Conditions and measures related to external treatment of waste for disposal
Particular considerations on the waste treatment operations: No (low risk) (ERC based assessment demonstrating control of risk with default conditions. Low risk assumed for waste life stage. Waste disposal according to national/local legislation is sufficient.)
Other given operational conditions affecting environmental exposure
Receiving surface water flow ≥ 1.8 X 104 m3/days
Section 3: Exposure estimation and reference to its source
Contributing scenario controlling environmental exposure (1)
ERC10a Use in articles
Release route Release rate Release estimation method
Water 0.018 kg/day ERC based
Air 2.75 X 10-4 kg/day ERC based
Soil 0.018 kg/day ERC based
Protection target Exposure estimation Risk characterisation ratio
Fresh water 3.754 X 10-4 mg/L <0.01 Sea water 3.635 X 10-5 mg/L <0.01 Sewage treatment plant 0.001 mg/L <0.01 Man via Environment - Inhalation 2.912 X 10-11 mg/m³ <0.01 Man via Environment - Oral 7.33 X 10-5 mg/kg bw/day <0.01 Section 4: Guidance to DU to evaluate whether he works inside the boundaries set by the ES
No additional risk management measures, besides those that are mentioned above, are needed to guarantee safe use for workers.
241/243
![Page 242: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/242.jpg)
Malic Acid
Revision: 8 Page: 240/241 Date: 27/10/2015
Exposure Scenario 29: Service life articles used by consumers
Section 1: Title of exposure scenario
Contributing scenario controlling environmental exposure
ERC10a, ERC11a Service life articles used by consumers
Exposure scenario of the uses leading to the inclusion of the substance into the article
ES6: Consumer Use - Consumer water treatment and cleaning product use ES9: Consumer Use - Consumer cosmetics, pharmaceuticals and personal care products ES11: Use at industrial site - Use at industrial sites of dyestuffs and in textiles uses ES13: Use at industrial site - Use at industrial sites in construction products ES14: Use by professional worker - Professional creation of building materials and articles ES15: Consumer Use - Consumer building product use ES17: Use at industrial site - General Industrial use of coatings and inks ES19: Use by professional worker - Professional painting and coatings ES20: Consumer Use - Consumer painting and coatings ES21: Use at industrial site - General industrial use in production of polymers and resins ES22: Use by professional worker - Professional use of resins ES23: Consumer Use - Consumer resin use
Section 2: Operational conditions of use
Contributing scenario controlling environmental exposure (1)
ERC10a Service life articles used by consumers
Amounts used, Frequency and duration of use
Daily wide dispersive use ≤ 5.5 X 10-4 tonnes/day
Percentage of tonnage used at regional scale
10%
Conditions and measures related to municipal sewage treatment plant
Municipal STP Yes. [Effectiveness - Water: 87.34%]
Discharge rate of STP ≥ 2 X 103 m3/days
Application of the STP sludge on agricultural soil
Yes
Conditions and measures related to external treatment of waste for disposal
Particular considerations on the waste treatment operations: No (low risk) (ERC based assessment demonstrating control of risk with default conditions. Low risk assumed for waste life stage. Waste disposal according to national/local legislation is sufficient.)
Other given operational conditions affecting environmental exposure
Receiving surface water flow ≥ 1.8 X 104 m3/days
242/243
![Page 243: Ficha de datos de seguridad de '901143 - ACIDO MALICO ...€¦ · Ficha de datos de seguridad según 1907/2006/CE (REACH), 2015/830/EU ... 7.1 Precauciones para una manipulación](https://reader034.fdocuments.es/reader034/viewer/2022051606/6029a5be54e36452df646af6/html5/thumbnails/243.jpg)
Malic Acid
Revision: 8 Page: 241/241 Date: 27/10/2015
Section 3: Exposure estimation and reference to its source
Contributing scenario controlling environmental exposure (1)
ERC10a Use in articles
Release route Release rate Release estimation method
Water 0.018 kg/day ERC based
Air 2.75 X 10-4 kg/day ERC based
Soil 0.018 kg/day ERC based
Protection target Exposure estimation Risk characterisation ratio
Fresh water 3.754 X 10-4 mg/L <0.01 Sea water 3.635 X 10-5 mg/L <0.01 Sewage treatment plant 0.001 mg/L <0.01 Man via Environment - Inhalation 2.912 X 10-11 mg/m³ <0.01 Man via Environment - Oral 7.33 X 10-5 mg/kg bw/day <0.01 Section 4: Guidance to DU to evaluate whether he works inside the boundaries set by the ES
No additional risk management measures, besides those that are mentioned above, are needed to guarantee safe use for workers.
243/243