Registration Dossier
Registration Dossier
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EC number: 224-631-8 | CAS number: 4431-83-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
According to column 1 of REACH annex VII and VIII, in vitro gene mutation study in bacteriaIn (8.4.1), in vitro cytogenicity study in mammalian cells or in vitro micronucleus study (8.4.2) and in vitro gene mutation study in mammalian cells (8.4.3) are required.
As the three tests show a negative result, the test substance is not genotoxic.
According to column 2 of REACH annex IX, as no positive result in any of the in vitro genotoxicity studies in Annex VII
or VIII a, in vivo somatic cell genotoxicity study is not required.
Justification for selection of genetic toxicity endpoint
The OECD TG 476 test was selected as the last test required by REACH for mutagenicity whereas OECD TG 471 and 487 tests are also required.
Short description of key information:
Three tests were performed to assess the genotoxicity potential of the test substance with a negative result in these three tests:
- OECD TG 471 - Bacterial Reverse Mutation Test
- OECD TG 487 - In Vitro Mammalian Cell Micronucleus Test
- OECD TG 476 - In vitro Mammalian Cell Gene Mutation Test
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
With a negative result in the 3 required studies, the test substance is not classified for its genotoxic potential.
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