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EC number: 278-115-2 | CAS number: 75199-13-2
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Not mutagenic
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Three reverse mutation bacterial mutagenesis assays (Ames tests) were performed on Disperse Yellow 231. All three assays were performed both in the presence and absence of metabolic activation using Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and TA1538. In the test form 1982, an additional strain was tested (Escherichia coli WP2 uvrA).
The Ames tests from 1982 and 1980 did not demonstrate any evidence of increased frequency of revertant colonies at any concentration, with or without metabolic activation, in any strain. In the Ames test from 2000, test item showed weak evidence of mutagenic potential in S. typhimurium strains TA98 and TA1538 in the presence of metabolic activation.
An additional in vitro mutagenesis test was performed: a thymidine kinase (tk) mouse lymphoma assay was performed to evaluate the potential for the substance to elicit a mutagenic effect in the L5178Y mouse lymphoma cells. Test item resulted to be non mutagenic in this assay.
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008), the term mutation refers a permanent change in the amount or structure of the genetic material in a cell, both to heritable genetic changes that may be manifested at the phenotypic level and to the underlying DNA modifications when known (including specific base pair changes and chromosomal translocations). The terms mutagenic and mutagen are used for agents giving rise to an increased occurrence of mutations in populations of cells and/or organisms.
For the purpose of the classification for germ cell mutagenicity, substances may be allocated to one of two categories:
- Category 1: substances known to induce heritable mutations or to be regarded as if they induce heritable mutations in the germ cells of humans or substances known to induce heritable mutations in the germ cells of humans. Further sub-classification can be made into the following:
- Sub-category 1A: in the presence of positive evidence from human epidemiological studies; or
- Sub-category 1B: in the presence of positive result(s) from (i) in vivo heritable germ cell mutagenicity tests in mammals; (ii) in vivo somatic cell mutagenicity tests in mammals, in combination with some evidence that the substance has the potential to cause germ cells mutations (derived from mutagenicity/genotoxicity tests in germ cells in vivo, or by demonstrating the ability of the substance or its metabolite(s) to interact with the genetic material of germ cells); or (iii) tests showing mutagenic effects in the germ cells of humans, without demonstration of transmission to progeny; for example, an increase in the frequency of aneuploidy in sperm cells of exposed people.
- Category 2: substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans. Classification in Category 2 is based on positive evidence obtained from experiments in mammals and/or in some cases from in vitro experiments, obtained from either (i) somatic cell mutagenicity tests in vivo, in mammals; or (ii) other in vivo somatic cell genotoxicity tests which are supported by positive results from in vitro mutagenicity assays.
Based on available experimental results, i.e. no increse of gene mutation in mammalian cells and only a weakly positive result for bacterial cell mutagenic potential in one out of three Ames tests, Disperse Yellow 231 is considered not mutagenic. Therefore, no classification for genotoxicity is warranted according to the CLP Regulation (EC 1272/2008).
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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