Registration Dossier
Registration Dossier
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EC number: 610-916-8 | CAS number: 5294-61-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Key study: The test item was tested for potential mutagenic activity using the Bacterial Reverse Mutation Assay according to OECD Guideline 471 following the Principles of GLP. The experiments were carried out using Salmonella typhimurium strains TA 98, TA 100, TA 1535 and TA 1537 and Escherichia coli WP2 uvrA in the presence and absence of metabolic activation (S9 fraction prepared from the livers of rats). None of the observed revertant colony numbers were above the respective biological threshold value. There were no dose-related trends and no indication of any treatment effect. In all test item treated groups, the numbers of revertant colonies did not exceed the biological relevance when compared to the solvent control and were within the normal biological variability of the test system. Inhibitory, cytotoxic effect of the test item was observed in the Confirmatory Mutation Test at 5000 µg/plate concentration in all tested Salmonella typhimurium strain without metabolic activation. The tests were considered to be valid. In conclusion, the test item had no mutagenic activity in the bacterium tester strains under the test conditions used in this study.
Justification for selection of genetic toxicity endpoint
Only one study available.
Short description of key information:
Key study: Test method according to OECD Guideline 471. GLP study. The test item had no mutagenic activity in the applied bacterium tester strains under the tests conditions used in this study.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the available data, the substance is not classified for mutagenicity according to CLP Regulation (EC) no. 1272/2008.
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