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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 (GLP study). The experiments were carried out using Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 and Escherichia coli WP2 uvrA in the presence and absence of metabolic activation (S9 fraction prepared from the livers of rats).

In the Initial Mutation Test and Confirmatory Mutation Tests (using the plate incorporation method), a clear, reproducible positive effect was obtained in three examined bacterial strains (Salmonella typhimurium TA98 and TA1537, and Escherichia coli WP2 uvrA) with and/or without metabolic activation as the observed revertant colony numbers were above the respective biological threshold value and dose-related trends were also observed. In the most sensitive strain (Salmonella typhimurium TA1537) the positive effect was seen right down to the lowest tested concentration, indicating a strong mutagenic activity of the test item. No insolubility or signs of cytotoxicity were detected on the plates in the main tests in any examined strains with and without metabolic activation. The tests were considered to be valid.

Justification for selection of genetic toxicity endpoint
Only one study available.

Short description of key information:
Key study: Test method OECD 471.GLP study. The test item had mutagenic activity in the examined bacterial strains.

Endpoint Conclusion: Adverse effect observed (positive)

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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