Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Besides these negative findings on mutagenicity Pigment Red 112 is unlikely to become bioavailable after oral, dermal or inhalation exposure and therefore does not have to be classified as germ cell mutagen.


Short description of key information:
Under the experimental conditions reported, including the Prival test method modification for azo compounds, the substance (Pigment Red 112) did not induce gene mutations by frameshifts or base-pair substitutions in the genome of the strains used. Therefore, the Pigment Red 112 is considered to be non-mutagenic in this Salmonella typhimurium reverse mutation assay (Hoechst, 1996). Several further mutagenicity tests in bacteria revealed also negative results for Pigment Red 112 (Bioservice, 2007a; 2007b; RCC, 2005a; 2005b; Ciba-Geigy, 1986).

Pigment Red 112 was not genotoxic in the mammalian cell gene (HPRT) mutation test in V79 Chinese Hamster cells when tested with and without rat liver S9 metabolic activation at concentrations up to 400 µg/ml.

In an in-vitro micronuclus assay in Chinese hamster V79 cells, Pigment Red 112 at concentrations up to 31.3 µg/ml did not induce micronuclei in the absence and presence of metabolic activation. Therefore, Pigment Red 112 can be considered as non-mutagenic in this in vitro test system, when tested up to precipitating concentrations.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Pigment Red 112 does not have to be classified for mutagenicity according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC) because Pigment Red 112 did not reveal any mutagenic effect in several bacterial reverse mutation assays in the presence or absence of metabolic activation at concentrations up to 5000 µg/plate, in the mammalian cell gene (HPRT) mutation test in V79 Chinese Hamster cells at concentrations up to 400 µg/ml and in the in vitro micronucleus test in V79 cells at up to a precipitating concentration of 31.3 µg/ml.