Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

OECD 471, 2004 - The study was performed to the requirements of OECD Guideline 471, EU Method B13/14 and Japanese guidelines for bacterial mutagenicity testing under GLP, to evaluate the potential mutagenicity of the test substance in a bacterial reverse mutation assay using S.typhimurium strains TA98, TA100, TA1535, TA1537 and E.coli strain WP2uvrA- in both the presence and absence of S-9 mix. A preliminary test was performed to determine the toxicity of the test material. A range-finding study was performed to determine the doses used for the main test. In the main test, the plate incorporation method was used and was evaluated at a concentration of up to 5000 µg/plate. Positive controls appropriate for each strain, in the presence and absence of S9 -mix, were included. The test substance did not induce any significant, reproducible increases in the observed number of revertant colonies in any of the strains tested, either in the presence or absence of S9-mix. The vehicle (acetone) control plates gave counts of revertant colonies within the normal range. All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with or without metabolic activation. Thus, the sensitivity of the assay and the efficacy of the S9-mix were validated. The test material caused a visible reduction in the growth of the bacterial background lawns at 5000 µg/plate to the majority of the Salmonella strains in the absence of S9 and to TA100 and TA1535 in the presence of S9. No toxicity was noted for Escherichia coli strain WP2uvrA-. The test material was, therefore, tested up to the maximum recommended dose level of 5000 µg/plate. No test material precipitate was observed on the plates at any of the doses tested in either the presence or absence of S9-mix. It was concluded that, under the conditions of this assay, the test substance gave a negative, i.e. non-mutagenic response in S.typhimurium strains TA98, TA100, TA1535, TA1537 and E.coli strain WP2uvrA- in the presence and absence of S-9 mix.


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, Safepharm Laboratories Ltd. 2007

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The substance does not meet classification criteria under EU Directive 67/548/EEC for mutagenicity

The substance does not meet classification criteria under Regulation (EC) No 1272/2008 for mutagenicity