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EC number: 260-124-8 | CAS number: 56358-09-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Carcinogenicity
Administrative data
Description of key information
Key value for chemical safety assessment
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to carcinogenicity.There is not sufficient information for classification according to CLP criteria for Category 2; the placing of a substance in Category 2 is done on the basis of evidence obtained from human and/or animal studies, but which is not sufficiently convincing to place the substance in Category 1A or 1B. Such evidence may be derived either from limited evidence of carcinogenicity in human studies or from limited evidence of carcinogenicity in animal studies.
Human and/or animal studies for Solvent Red 19E are not available with regard to carcinogenic potential or metabolism of the substance in the body.
Additional information
Three different mechanisms for azo dye carcinogenicity have been identified, all involving metabolic activation to reactive electrophilic intermediates that covalently bind DNA:
- Azo dyes that are toxic only after reduction and cleavage of the azo linkage to give aromatic amines, mostly via intestinal anaerobic bacteria. The aromatic amines are metabolically oxidized to reactive electrophilic species that covalently bind DNA.
- Azo dyes with structures containing free aromatic amine groups that can be metabolically oxidized without azo reduction.
- Azo dyes that may be activated via direct oxidation of the azo linkage to highly reactive electrophilic diazonium salts.
Each mechanism may be compound specific, thus azo toxicity is probably caused by more than one mechanism. Therefore it is not possible to predict azo dye carcinogenicity with absolute certainty. Because some species of intestinal anaerobic bacteria (and in some cases, hepatic azo reductases) may reduce any azo compound to aromatic amines, those containing aromatic amine subgroups known to be carcinogenic must be suspect. (Brown, M.A., De Vito, S.C., Predicting azo dye toxicity, Critical Reviews in environmental Science and Technology, Vol. 23, Issue 3, 1993).
In the case of Solvent Red 19E and similar dyes, the azo group can be given off enzymatically in the body and o-toluidine can be formed. o-toluidine has been found to be carcinogenic in animal studies (o-toluidine has a harmonised classified as Carc. 1B with the hazard statement H350).
The oral exposure of the substance is not expected as the substance is used by industrial and professional workers. There may be a potential risk of skin cancer from prolonged or repeated skin contact with this product in the absence of good personal hygiene. Occasional skin contact with this product is not expected to have serious effects, but good personal hygiene should be practised and repeated skin contact avoided. This product is classified as skin irritant and skin sensitizer. Personal hygiene measures taken to prevent skin irritation and skin sensitisation are expected to be adequate to prevent undue risk of skin cancer.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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