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HC Blue No 2 was investigated for its ability to induce gene mutations in bacteria and mammalian cells. HC Blue No 2 was positive in Salmonella typhimurium strain TA98 in the absence of metabolic activation in two guideline gene mutation tests in bacteria. In a further study a negative result was obtained both in the absence and presence of metabolic activation. HC Blue No 2 was considered not to be genotoxic (mutagenic) in a gene mutation study in mammalian cells (hprt locus) either in the absence or presence of metabolic activation. HC Blue No 2 induced micronuclei but not chromosomal aberrations in human peripheral lymphocytes in vitro. HC Blue No 2 was negative for clastogenic/aneugenic potential in an in vivo rat bone marrow micronucleus study. Although HC Blue No 2 showed mutagenic activity in the Salmonella typhimurium assay, this activity was observed only in strain TA 98 in the absence of metabolic activation. This activity was not confirmed in an in vitro gene mutation test in mammalian cells. The clastogenic/aneugenic potential of HC Blue No 2 observed in vitro does not lead to clastogenic/aneugenic effects in experimental animals under appropriate test conditions. HC Blue No 2 is considered to have no mutagenic potential.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification