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Diss Factsheets
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EC number: 407-250-3 | CAS number: 130201-55-7
- 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
Additional information
The genotoxic potential of the test substance was investigated in-vitro and in-vivo.
The positive response in the Ames Test is assessed as false-positive. This is justified by the clear negative results in two subsequently performed Ames Tests (one standard protocol, one modified version for azo dyes) and the absence of any genotoxic or mutagenic response in an HPRT-gene mutation assay in-vitro as well as an UDS-assay performed in-vivo.
It is widely accepted that the metabolic conditions of the standard Ames test protocol are not appropriate for testing azo dyes for mutagenic activity in Salmonella typhimurium. Instead,a specific protocol should be followed to reduce the azo compounds to free amines. The conversion of the parent compound by azo-reduction in vivo results in the formation of sulphonated arylamines as well as unsulphonated aromatic amines that may not be formed in the standard in vitro genotoxicity tests. There is evidence of sulphonated aromatic amines not being associated with genotoxicity in vitro and in vivo. In contrast to their unsulphonated analogues they have no or very low genotoxic potential. Hence it was concluded that exposure to sulphonated aromatic amines are unlikely to induce any significant genotoxic risk.
The in-vitro chromosome aberration test in V79 chinese hamster cell line revealed a slight increase of chromosomal aberrations by the test article compared to controls. The subsequently conducted in-vivo micronucleus test however was devoid of a genotoxic response.
The studies were found to be adequate to fufill the purposes of this endpoint.
Short description of key information:
in-vitro: positive in Ames Test with Salmonella strains TA 98, TA 100, TA 1535, TA 1537 and 1538 (with and without microsomal activation)
in-vitro: negative in Ames Test with Salmonella strains TA 98, TA 100, TA 1535, TA 1537 and 1538 and E.coli Wp2 (with and without microsomal activation)
in-vitro: negative in Prival-Ames with Salmonella strains TA 98, TA 100
in-vitro: negative in hprt-gene mutation assay in Chinese Hamster V79 cells
in-vivo: negative in micronucleus assay in Chinese Hamster bone marrow cells
in-vivo: negative in Dominant Lethal Study in mice
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
There are multiple and conclusive data to prove that classification of the test substance with regard to mutagenicity is not indicated.
The substance is not classified for this endpoint in accordance to Directive 67/548/EEC or the CLP Regulation (EC) No 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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