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Administrative data

Key value for chemical safety assessment

Additional information

The test substance was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of several strains of Salmonella typhimurium in a modified version of the traditional Ames test, i.e. the Ames II assay (microtiter version) (based on the description of Gee, P. et al) (BASF 2002). The Salmonella typhimurium strains (TA 98, and mixed strains TA 7001 – TA 7006) were used to test the mutagenic potential, both with and without metabolic activation. Inthe first experiment TA98 and TA mix were exposed to 4 -5000µg/mL test substance. In the second experiment, TA98 was exposed to 1000 -6000 µg/mL test substance.No precipitation of the test substance was found and no bacteriotoxic effect was observed. An increase in the number of positive wells (his+ revertants) was not observed either without S-9 mix or after the addition of a metabolizing system. According to the results of the present study, the test substance is not mutagenic in the Ames II Assay under the experimental conditions chosen here.


Justification for selection of genetic toxicity endpoint
One genetic toxicity in vitro study is available. This study is adequate for covering this endpoint.

Short description of key information:
The test substance is not a mutagenic substance in a modified version of the traditional Ames test, i.e. the Ames II Assay (microtiter version) in the absence and the presence of metabolic activation.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The test substance was not mutagenic in the performed Ames II assay. However, since the Ames II test is a screening test instead of a official OECD guideline classification for genetic toxicity is not possible in accordance with EU Directive 67/548 (DSD) and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.