Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Pigment Red 254 was not genotoxic in this Salmonella typhimurium reverse mutation assay when tested with and without rat liver S9 metabolic activation.

Pigment Red 254 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 108 µg/mL.


Justification for selection of genetic toxicity endpoint
Evaluation of genetic toxicity is based on a battery of different study protocols comprising in the case at issue:
OECD TG 471, Bacterial Reverse Mutation Test (KEY_471_2010_Harlan_1312400)
OECD TG 476, In vitro Mammalian Cell Gene Mutation Test, HPRT (KEY_476_2014_Harlan_1583700)

Short description of key information:
Mutagenic properties of Pigment Red 254 were investigated in a bacterial reverse mutation assay (Ames test; tester strains used: S. typhimurium TA 98, TA 100, TA 102, TA 1535, and TA 1537) and in an in vitro gene mutation study in mammalian cells (HPRT assay in V79 cells). Negative results were obtained in all tests with and without exogenous metabolic activation.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Pigment Red 254 does not have to be classified for mutagenicity according to the criteria laid down in Directive 67/548/EEC and in Regulation (EC) No 1272/2008 because Pigment Red 254 did not reveal any mutagenic effects in the bacterial reverse mutation assay in the presence or absence of metabolic activation and in the in vitro gene mutation study in mammalian cells (HPRT assay in V79 cells) in the presence or absence of metabolic activation.