Registration Dossier
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EC number: 811-502-1 | CAS number: 73206-60-7
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
In a GLP compliant bacterial mutagenicity assay (Ames preincubation test), performed according to OECD 471, using four Salmonella typhimurium strains (TA 1535, TA 1537, TA98, and TA100) and one Escherichia coli WP2 uvrA strain, the test substance was evaluated in the presence and absence of rat liver derived metabolic activation system (S9 -mix).
In a preliminary study, the substance was tested at 1.22, 4.88, 19.5, 78.1, 313, 1250, 5000 µg/plate with and without S9 mix. Two main experiments were performed in triplicate. The S. typhimurium strains with and without S9 mix and the E. coli without S9 mix were dosed with 2.44, 4.88, 9.77, 19.5, 39.1, 78.1 µg/plate. The E. coli strains with S9 mix were dosed with 9.77, 19.5, 39.1, 78.1, 156, 313 µg/plate.The vehicle used was dimethyl sulphoxide. All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with or without metabolic activation. Precipitation of the test substance was observed at 1250 µg/plate or more in all tester strains without S9 mix, at 5000 µg/plate in all tester strains with S9 mix. Cytotoxicity was observed at 39.1 µg/plate or more (TA 100, TA 1535), 78.1 µg/plate (TA 98, TA 1537, WP2 uvrA) without the use of S9 mix. In combination with S9 mix cytotoxicity was observed at 78.1 µg/plate (TA 98, TA 100, TA 1535, TA 1537), 156 µg/plate or more (WP2 uvrA). An increase in the number of his+ or trp+ revertants was not observed either without S9 mix or after the addition of a metabolizing system. It was therefore concluded that the test substance is not mutagenic under these experimental conditions.Short description of key information:
The test susbtance was considered to be not mutagenic in the Ames test.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the available information classification for genetic toxicity is not warranted in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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