Registration Dossier
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EC number: 232-353-3 | CAS number: 8007-18-9 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77788.
- 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
The test substance was found as non-mutagenic in three in vitro studies:
- Gene mutagenicity in bacteria Ames test (S. typhimurium strains TA 98, TA 100, TA 1535, TA 1537, TA 1538 and E. coli WP2 uvrA), with or without metabolic activation: negative (OECD 471, BASF, 1995).
- Gene mutagenicity in mammalian cells Mouse lymphoma assay, L5178Y cells, with or without metabolic activation: negative (OECD 476; CHV, 1996)
- Cytogenicity in mammalian cells Chromosome aberration, CHL cells, with or without metabolic activation: negative (OECD 473; BASF 2002).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Gene mutagenicity in bacteria
For the gene mutagenicity in bacteria, a GLP compliant study is available, which was performed according to OECD guideline 471 (BASF, 1995). The study was performed as plate incorporation tests with S. typhimurium strains TA 98, TA 100, TA 1535, TA 1537, TA 1538 and E. coli WP2 uvrA with or without metabolic activation up to 5000 µg/plate. All strains gave negative results. This result is supported by the negative result of another bacterial reverse mutation assay conducted with S. typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and E. coli strain WP2 uvrA with and without metabolic activation at doses of 2.29 -5000 µg/plate (MHLW, 2001).
Gene mutagenicity in mammalian cells
In an in vitro mammalian cell gene mutation assay according to OECD guideline 476, L5178Y cells cultured in vitro were exposed to C.I. Pigment Yellow 53 at concentrations of 3.13, 6.25, 12.5, 25, 50 and 100 µg/mL (suspension with DMSO) in the presence and absence of mammalian metabolic activation (Aroclor-induce rat liver (S9)) (BASF, 1996). Higher concentrations were not tested because of the insoluble nature of the test substance. All dosing solutions were washed to remove the visible precipitate before application. Two trials of the non-activation and the S9 metabolic activation mutation assays were performed but the first trial was disregarded because of problems in the cell cultures. In Trial 2, six treatments from 3.13 µg/mL to 100 µg/mL were initiated and all doses were cloned for mutant analysis. No cytotoxicity was observed under either activation conditions. None of the six analysed treatments with or without metabolic activation induced a mutant frequency that exceeded the minimum criterion for a positive response. Nickel Antimony Titanate was therefore evaluated as negative with and without metabolic activation at the TK locus in L5178Y mouse lymphoma cells under the conditions used in this study.
Cytogenicity in mammalian cells
In a mammalian chromosomal aberration test according to OECD guideline 473 (MHLW 2002), Chinese hamster lung cells (CHL/IU) were exposed to the test substance at concentrations of:
- 9.79, 19.5, 39.1 μg/mL without metabolic activation (short term treatment, -S9)
- 19.5, 39.1, 78.1 μg/mL with metabolic activation (short term treatment,+S9)
- 4.88, 9.75, 19.5 μg/mL without metabolic activation (continuous treatment, 24 hours)
The S9 mix was composed of phenobarbital- and 5,6-benzoflavone-induced rat liver. No increase in chromosomal aberrations was observed in the test with either the short term treatment (-S9 mix and +S9 mix) or the continuous treatment.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. Based on the available in vitro data, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the ninth time in Regulation (EC) No 2016/1179.
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