Registration Dossier
Registration Dossier
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EC number: 269-054-2 | CAS number: 68186-92-5 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77896.
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
C.I. Pigment Yellow 164
For the gene mutagenicity in bacteria, two valid studies were available, which were both performed according to OECD TG 471 but did not follow GLP requirements (BASF 1985a, 1985b). Both studies were performed as repeated standard plate tests with S. typhimurium strains TA1535, TA1537, TA98 and TA100 with or without metabolic activation up to 5000 µg/plate; a strain to detect crosslinking/ oxidising agents was not included in the studies. In one study, TA1535 produced equivocal results without metabolic activation. In the test repeat and the complete other study, TA1535 produced negative results. All other strains were negative, too. Since not all evaluation criteria (maximum revertant factor >2, repeatable result) were fulfilled, the substance was assessed to be negative under the conditions of the test.
In vivo tests are considered as not relevant since the test substance is not bioavailable.
C.I. Pigment Brown 24
Gene mutagenicity in bacteria
For the gene mutagenicity in bacteria, a GLP compliant study is available, which was performed according to OECD guideline 471 (Corning Hazleton 1985). 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 tested negative.
Gene mutagenicity in mammalian cells
A GLP compliant mouse lymphoma assay was performed according to OECD guideline 476, with L5178Y cells, with and without metabolic activation and test concentrations up to 100 µg/mL (Corning Hazleton 1996). Due to technical reasons, the first trial was considered as not acceptable. However, no mutagenicity was found also in the second trial.
Cytogenicity in mammalian cells
A GLP compliant in vitro micronucleus test was performed according to OECD guideline 487 (BASF 2001). CHL V79 cells were exposed to up to 900 µg/mL (Mixed Population Method) or up to 50 µg/mL (Mitotic Shake Off Method) with or without metabolic activation. Under all tested conditions, the test was negative.
In vivo tests are considered as not relevant since the test substance is not bioavailable.
C.I Pigment Yellow 53
Gene mutagenicity in bacteria
For the gene mutagenicity in bacteria, a GLP compliant study is available, which was performed according to OECD guideline 471 (Corning Hazleton 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.
Gene mutagenicity in mammalian cells
A GLP compliant mouse lymphoma assay was performed according to OECD guideline 476, with L5178Y cells, with and without metabolic activation and test concentrations up to 100 µg/mL (Corning Hazleton 1996). No mutagenicity was found.
Cytogenicity in mammalian cells
A GLP compliant chromosome aberration test was performed according to OECD guideline 473 (MHLW 2002). CHL cells were exposed to up to 1250 µg/mL with or without metabolic activation. Under all tested conditions, the test was negative.
In vivo tests are considered as not relevant since the test substance is not bioavailable.
Short description of key information:
No test data for Genetic Toxicity of Chrome tungsten titanium buff rutile are available. However, Genetic Toxicity data are available for three structural and chemical analogues: C.I. Pigment Yellow 164, CAS no. 68412-38-4; C.I. Pigment Brown 24, CAS no. 68186-90-3, and C.I. Pigment Yellow 53, CAS no. 8007-18-9.
C.I. Pigment Yellow 164
Gene mutagenicity in bacteria
Ames test (S. typhimurium TA1535, TA1537, TA98 and TA100): negative (only TA1535 was equivocal in 1/4 trials; BASF 1985a, 1985b).
No data available for gene mutagenicity and cytogenicity in mammalian cells in vitro and in vivo, respectively.
C.I. Pigment Brown 24
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, Corning Hazleton 1985).
Gene mutagenicity in mammalian cells
Mouse lymphoma assay, L5178Y cells, with or without metabolic activation: negative (OECD 476; Corning Hazleton 1996)
Cytogenicity in mammalian cells
Micronucleus formation in vitro, CHL V79, with or without metabolic activation: negative (OECD 487; BASF 2001).
C.I. Pigment Yellow 53
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, Corning Hazleton 1995).
Gene mutagenicity in mammalian cells
Mouse lymphoma assay, L5178Y cells, with or without metabolic activation: negative (OECD 476; Corning Hazleton 1996)
Cytogenicity in mammalian cells
Chromosome aberration, CHL cells, with or without metabolic activation: negative (OECD 473; MHLW 2002).
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
No indications of mutagenic toxicity from experimental results. The substance class is considered as not bioavailable.
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