Registration Dossier
Registration Dossier
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EC number: 224-764-1 | CAS number: 4482-25-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The analogue substance 2 was found to cause positive mutagenic effects in bacterial tests. However, the findings were not confirmed in mammalian cells in vivo studies on two different analogue substances, having in common the central part of the molecule based on diazotised aromatic amines.
Based on the read across considerations, the same results apply to Solvent Brown 12.
Justification for selection of genetic toxicity endpoint
The mutation tests in in vivo (in vivo Micronucleus and USD) is a model clearly closer to the human situation than the Ames Test in bacteria and are considered more relevant than the bacterial test system. The negative results of these tests are confirmed in two studies (in vivo micronucleus on analogue substance 3 and UDS on analogue substance 2)
Short description of key information:
Two in vivo mammalian gene mutation tests gave no indication of mutagenic potential
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
According to the CLP Regulation (EC n. 1272/2008), for the purpose of the classification for germ cell mutagenicity, substances are allocated in one of two categories in consideration of the fact that they are:
- substances known to induce heritable mutations or to be regarded as if they induce heritable mutations in the germ cells of humans or substances known to induce heritable mutations in the germ cells of humans or
- substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans.
According to the ECHA Guidance R7.a Table R.7.7-5, in the presence of a positive result in Gene Mutation on bacteria test, a negative result in the “Cytotoxicity in vitro” test and a negative result in “Gene mutation in vivo” test, the substance can be stated as non genotoxic.
In conclusion, the substance is not classified for genetic toxicity according to the CLP Regulation (EC n. 1272/2008).
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