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Bacterial Reverse Mutation Assay (Ames Test)

A GLP compliant bacterial reverse mutation test was performed according to OECD 471 and EU method B.13/14 (BASF, 2010) wih the test substance. The test item was tested in the reverse mutation assay with four histidine-requiring strains of Salmonella typhimurium (TA1535, TA1537, TA98 and TA100) and with a tryptophan-requiring strain of Escherichia coli (WP2uvrA). The test was performed in two independent experiments in the presence and absence of S9 mix (rat liver S9 mix induced by a combination of phenobarbital and beta-naphthoflavone). The test substance was dissolved in ethanol. 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 dose levels of 1000 µg/plate and upwards. 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. Results of this dose range finding test were reported as part of the first experiment of the 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 10 to 1000 µg/plate in the absence and presence of 5% (v/v) S9 mix in tester strains TA1535, TA1537 and TA98. In an independent repeat of the assay with additional parameters, the test substance was tested at the same concentration range as the first assay in the absence and presence of 10% (v/v) S9 mix in tester strains TA1535, TA1537, TA98, TA100 and WP2uvrA. the test substance precipitated on the plates at the top dose of 1000 µg/plate. 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 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 tester strain WP2uvrA both in the absence and presence of S9 metabolic activation. These results were confirmed in an independently repeated experiment.

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.

Based on the results of this study it is concluded that the test substance is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.


Short description of key information:
Ames Test (BASF, 2010): negative

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available in vitro studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result, the substance is not considered to be classified for mutagenicity under Directive 67/548/EEC, as amended for the 31st time in Directive2009/2/EC.

 

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result, the substance is not considered to be classified for mutagenicity under Regulation (EC) No 1272/2008, as amended for the fifth time in Directive EC 944/2013.