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Key value for chemical safety assessment

Additional information

Five bacterial strains, Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Escherichia coli WP2 uvrA were used to investigate the mutagenic potential of Intermediate 36 in three independent experiments, in a plate incorporation test (Experiment I, Initial Mutation Test) and in two pre-incubation tests (Experiment II, Confirmatory Mutation Test and Experiment III, Complementary Confirmation Mutation Test). Experiments I-II were carried out with and without metabolic activation (±S9-mix), Experi-ment III was performed without metabolic activation system. The concentrations, including the controls, were tested in triplicates.

The test item was dissolved in Acetone. In the Initial Mutation Test and Confirmatory Mutation Test the tested concentrations were: 5000, 1581, 500, 158.1, 50, 15.81, 5, 1.581 and 0.5 μg/plate. This series was completed in the Complementary Confirmatory Mutation Test with additional concentration levels of 0.1581 and 0.05 μg/plate.

Using the plate incorporation method (Experiment I), there were no cases of the number of revertant colonies above the historical control range; there were no dose-related higher reverant numbers. The mutation factor values were all below the biological relevant threshold value, no mutagenic effect was detected.

A strong inhibitory, cytotoxic effect of the test item was observed in all bacterial strains using the plate incorporation method. Reduced background lawn development, appearance of pinpoint colonies and reduced number of revertant colonies was observed in the Initial Mutation Test (Experiment I). There were an adequate number of concentrations below the cytotoxic range for a valid study. The reported data of this mutagenicity assay show, that under the experimental conditions reported, the test item did not induce gene mutations by frameshift or base-pair substitution in the genome of the strains used. Therefore, Intermediate 36 is considered non-mutagenic in this bacterial reverse mutation assay.

Short description of key information:
The test substance Intermediate 36 was examined in a Reverse Mutation Assay using Bacteria and considered to be non-mutagenic in this bacterial reverse mutation assay.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the results obtained in this study, Intermediate 36 does not have to be classified for genetic effects according to Directive 67/548/EEC and Regulation /EC) No 1272/2008 (CLP).