Registration Dossier

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.