Registration Dossier
Registration Dossier
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EC number: 203-404-7 | CAS number: 106-50-3
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Several bacterial reverse mutation assays are available with the test substance, using several types and strains of bacteria. Based on a weight of evidence, the genotoxic potential was considered to be positive with metabolic activation in bacteria. In addition, the test substance was positive without metabolic activation in an in vitro chromosome aberration study, and positive with metabolic activation in an in vitro micronucleus test.
Therefore, an in vivo micronucleus study in accordance with OECD TG474 and an in vivo UDS test in accordance with OECD TG486 were performed. Based on the results of these studies, the test substance can be considered not genotoxic
Short description of key information:
In vivo micronucleus study (OECD TG474):
Under the conditions of the study, the test substance did not induce cytogenetic damage leading to micronucleus formation in the bone marrow of rats treated orally up to the maximal tolerated dose of 100 mg/kg, with clear demonstration that treated animals were exposed systemically. Therefore, the test substance was considered to be non-genotoxic in this micronucleus assay.
In vivo UDS test (OECD TG486):
Under the conditions of the study, there was no DNA damage leading to unscheduled DNA synthesis in hepatocytes obtained from rats treated orally with the test substance up to the Maximal Tolerated Dose of 100 mg/kg, with clear demonstration that animals were systemically exposed to the test item. Therefore, the test substance was considered to be non-genotoxic in the in vivo unscheduled DNA synthesis in rat hepatocytes.
Endpoint Conclusion: No adverse effect observed in vivo
(negative)
Justification for classification or non-classification
The test substance was genotoxic in vitro with or without metabolic activation. However, when tested in vivo no genotoxicity was observed. Therefore, the substance does not need to be classified for mutagenicity according the EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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