Multi constituent substance

Endpoint summary

Additional information

Short description of key information:
The genotoxicity of Basic Brown 17 has been investigated for the endpoints of gene mutations, structural and numerical chromosome aberration. Basic Brown 17 induced gene mutations in bacteria. Basic Brown 17 did not induce mutations in two in vitro gene mutation tests in mammalian cells at the tk locus and hprt locus. Basic Brown 17 was not considered mutagenic in an in vitro micronucleus test. The absence of both mutagenicity and clastogenicity in mammalian cells was confirmed in a Comet assay in reconstructed human skin. On the basis of a weight of evidence approach that the positive result in the gene mutation test in bacteria is not confirmed in three different tests measuring gene mutations in mammalian cells, Basic Brown 17 can be considered to have no in vivo genotoxic potential.

Endpoint Conclusion: No adverse effect observed (negative)