Registration Dossier
Registration Dossier
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EC number: 942-993-1 | CAS number: -
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). A range-finding study was performed to determine the doses used for the main test. Results of this dose range finding test were reported as part of the first mutation assay. The bacterial background lawn was not reduced at any of the concentrations tested and no biologically relevant decrease in the number of revertants was observed. 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. In the first mutation assay, oily droplets of the test substance on the plates were observed at dose levels of 1600 and 5000 μg/plate. In a follow-up experiment of the assay with additional parameters, the test substance was tested at a concentration range of 275 to 2800 µg/plate in the absence and presence of 10% (v/v) S9-mix in the tester strains TA1535, TA1537, TA98, TA100 and WP2uvrA. Oily droplets of the test substance on the plates were observed at dose levels of 878 μg/plate and upwards (absence of S9-mix) and 2800 µg/plate (presence of S9-mix).The bacterial background lawn was not reduced at any of the concentrations tested and no biologically relevant decrease in the number of revertants was observed. The test substance did not induce a biologically relevant or significant dose-related increase in the number of revertant (His+) colonies in each of the four tester strains (TA1535, TA1537, TA98 and TA100) and in the number of revertant (Trp+) colonies in the tester strain WP2uvrA both in the absence and presence of S9-metabolic activation. These results were confirmed in a follow-up experiment. In this study, acceptable responses were obtained for the negative and strain-specific positive control substances which 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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