Registration Dossier
Registration Dossier
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EC number: 915-335-6 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Gene mutation in bacteria (OECD 471, GLP): Not mutagenic.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
The test substance was evaluated in a bacterial reverse mutation assay performed according to OECD 471 and following GLP using Salmonella typhimurium strains TA98, TA100, TA 1535 and TA1537 and Escherichia coli strain WP2 uvrA both in the presence and absence of an exogenous metabolic activation system (S9 -mix). The test substance was evaluated using an initial plate incorporation assay and a confirmatory preincubation procedure in triplicate with and without metabolic activation. In the first experiment, test substance concentrations of 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate were assessed. In the second experiment, test substance concentrations of 0.15, 0.5, 1.5, 5, 15, 50, 150, 500 μg/plate (TA100, TA98), 0.5, 1.5, 5, 15, 50, 150, 500, 1500 μg/plate (TA1535), and 1.5, 5, 15, 50, 150, 500, 1500, 5000 μg/plate (WP2uvrA, TA1537) were assessed. The vehicle (dimethyl sulphoxide) control plates gave counts of revertant colonies within the normal range. All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with and without metabolic activation. Thus, the sensitivity of the assay and the efficacy of the S9-mix were validated. In the first mutation test (plate incorporation method), the test item induced a visible reduction in the growth of the bacterial background lawns of all of the tester strains, initially from 150 and 500 μg/plate in the absence and presence of metabolic activation, respectively. In the second experiment, the test item induced a visible reduction in the growth of the bacterial background lawns of all of the tester strains, initially from 150 and 500 μg/plate in the absence and presence of metabolic activation, respectively. No test item precipitate was observed on any of the plates. There were no significant biologically relevant increases in the frequency of revertant colonies recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation. Therefore, the test material was considered to be non-mutagenic under the conditions of this test.
Justification for classification or non-classification
Based on this study, it can be concluded that the substance is not mutagenic in bacteria.
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