Registration Dossier
Registration Dossier
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EC number: 210-323-0 | CAS number: 612-83-9
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
In the key study mutagenic activity of the test item was investigated in S. typhimurium strains TA 98, TA 100, TA 1535, and TA 1537 with and without metabolic activation. The test item was mutagenic in strain TA 98 with and without metabolic activation. It was negative in the strains TA 100, TA 1535 and TA 1537 without metabolic activation. With metabolic activation the test item was negative in strain TA 1535 and positive in strains TA 100 and TA 1537. Metabolic activation leads to an increase of mutagenicity in comparison to mutagenicity testing without metabolic activation.
Additional information from other studies, including information on the free base, support these findings and indicate that the test item is also genotoxic in mammalian cells in vitro (induction of sister chromatide exchanges and unscheduled DNA synthesis, cell transformation) and in vivo (induction of micronuclei, chromosomal aberrations and unscheduled DNA-synthesis). However as cited from secondary literature the reliability of these data is not assignable and consequently a final justification for classification based on these data wouldn’t be conclusively substantiated. As the substance is classified as carcinogenic category 2 no further investigations on mutagenic activity have to be performed.
Short description of key information:
Available data of differing reliability indicate that the test item and/or its free base induce gene mutation in bacteria, sister chromatide exchanges and unscheduled DNA synthesis in mammalian cells in vitro and transformation of mammalian cells. Binding to DNA, induction of micronuclei, chromosomal aberrations and unscheduled DNA-synthesis have been observed in vivo.
Endpoint Conclusion:
Justification for classification or non-classification
The test item is genotoxic in bacteria. Additional, less reliable information on the test item and the free base show induction of sister chromatide exchanges and unscheduled DNA synthesis in mammalian cells in vitro and genotoxicity in vivo. Summarizing it can be stated that available data presented provide no conclusive evidence that a classification as mutagenic substance according to Regulation (EC) no 1272/2008 or Council Directive 67/548/EEC is justified.
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