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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Ames test: Negative (OECD TG 471, GLP)

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

The test substance was tested in the Bacterial Reverse Mutation Assay, performed according to OECD TG 471 and following GLP, using Salmonella typhimurium tester strains TA98, TA100, TA1535 and TA1537 and Escherichia coli tester strain WP2 uvrA in the presence and absence of Aroclor-induced rat liver S9. The assay was performed using the plate incorporation method. DMSO was selected as the solvent based on the solubility of the test substance and compatibility with the target cells. The test substance formed a clear solution in DMSO at approximately 500 mg/mL, the maximum concentration tested in the solubility test. In the initial toxicity-mutation assay, the dose levels tested were 1.5, 5.0, 15, 50, 150, 500, 1500 and 5000 μg per plate. No positive mutagenic responses were observed with any of the tester strains in either the presence or absence of S9 activation. No precipitate was observed. Toxicity was observed beginning at 1500 or at 5000 μg per plate. Based on the findings of the initial toxicity-mutation assay, the maximum dose plated in the confirmatory mutagenicity assay was 5000 μg per plate. In the confirmatory mutagenicity assay, no positive mutagenic responses were observed with any of the tester strains in either the presence or absence of S9 activation. The dose levels tested were 5.0, 15, 50, 150, 500, 1500 and 5000 μg per plate with tester strains TA100, TA1535 and WP2 uvrA in the absence of S9 activation and tester strains TA98 and TA1535 in the presence of S9 activation and 15, 50, 150, 500, 1500 and 5000 μg per plate with the remaining test conditions. No precipitate was observed. Toxicity was observed beginning at 1500 or at 5000 μg per plate. Under the conditions of this study, the test substance was concluded to be negative in the Bacterial Reverse Mutation Assay.

Justification for classification or non-classification

Based on the results of the Ames test, the substance does not need to be classified for genotoxicity according to EU CLP (EC 1272/2008 and its amendments).

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