Registration Dossier
Registration Dossier
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EC number: 252-335-9 | CAS number: 35044-59-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
OECD TG 471, 2015 - The study was performed to OECD TG 471, EU Method B.13/14, EPA OPPTS 870.5100 and the Japan Guidelines for Screening Mutagenicity of Chemicals in accordance with GLP; to evaluate the mutagenic activity of the test substance in the Salmonella typhimurium and the Escherichia coli in a reverse mutation assay (with independent repeat). In the dose range finding test, the test substance was tested up to concentrations of 5000 µg/plate in the absence and presence of S9-mix in the strains TA100 and WP2uvrA. The test substance precipitated on the plates at the top dose of 5000 μg/plate. In tester strain TA100, toxicity was observed at dose levels of 1600 and 5000 μg/plate in the absence and presence of S9-mix. In tester strain WP2uvrA, no toxicity was observed at any of the dose levels tested. Results of this dose range finding test were reported as part of the first mutation assay. Based on the results of the dose range finding test, the test substance was tested in the first mutation assay at a concentration range of 52 to 5000 µg/plate in the absence and presence of 5% (v/v) S9-mix in the tester strains TA1535, TA1537 and TA98. The test substance was tested up to or beyond a precipitating dose level. Toxicity was observed in all three tester strains in the absence and presence of S9-mix. In a follow-up experiment of the assay with additional parameters, the test substance was tested at a concentration range of 154 to 5000 µg/plate in tester strain TA1535, at 492 to 5000 µg/plate in tester strains TA1537, TA100 and WP2uvrA and at 275 to 5000 µg/plate in strain TA98 in the absence and presence of 10% (v/v) S9-mix. The test substance precipitated on the plates at the top dose of 5000 μg/plate. Toxicity was observed in tester strains TA1535, TA1537 and TA100 in the absence and presence of S9-mix. In this study, the negative and strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly. Under the conditions of this study it is concluded that that the test substance was not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
Justification for selection of genetic toxicity endpoint
Study selected is an in vitro study (Klimisch 1)
Short description of key information:
negative, in vitro bacterial reverse mutation (with and without S-9 activation), OECD 471, Wil Research B.V. 2015
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
The substance does not meet classification criteria under Regulation (EC) No 1272/2008 for mutagenicity
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