Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Salmonella typhimurium, Reverse Mutation Assay (Ames test)

Pigment Red 254 (CAS# 84632-65-5) was tested in an in vitro gene mutation study in bacteria (Reverse Mutation Assay, Ames Test). The test was performed in accordance with GLP and none of the Salmonella typhimurium strains listed in the OECD guideline 471 ( S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102) displayed mutagenic activity, either in the absence or in presence of S9 mix.

Chromosome aberration (mammalian in vivo micronucleus test)

Pigment Red 254 (CAS# 84632-65-5) was tested in Chinese hamsters in a study equivalent or similar to OECD Guideline 474. At a single oral dose of 5000 mg/kg bw to 8 male and 8 female animals, there was no evidence that Pigment Red 254 (CAS# 84632-65-5) was mutagenic in this assay.


Short description of key information:
In vitro:

Gene Mutation (Bacterial Reverse Mutation Assay/Ames test): Pigment Red 254 (CAS# 84632-65-5) did not show mutagenic activity using S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 in the presence or absence of metabolic activation.

In vivo:

Chromosome aberration (mammalian in vivo micronucleus test): Pigment Red 254 (CAS# 84632-65-5) did not show mutagenic activity in a micronucleus test in Chinese Hamsters.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available information in the dossier, the substance Pigment Red 254 (CAS# 84632-65-5) does not need to be classified for genetic toxicity when the criteria outlined in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC are applied.