Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

In a reverse mutation assay according to OECD guideline 471, strains of Salmonella typhimurium (TA1535, TA1537, TA98, TA100) and Escherichia coli (WP2 uvrA) were exposed to concentrations in a range of 0.1 - 6100 µg/plate (plate incorporation) and 0.03 - 33 µg/plate (preincubation) (BASF SE, 2015). All experiments were conducted in the presence and absence of metabolic activation (S9 mix).

The test substance was tested up to cytotoxic concentrations. A strong bacteriotoxic effect was observed depending on the strain and test conditions from about 10 μg/plate under all test conditions. Precipitation of the test substance was found at in the standard plate test from about 3050 μg/plate onward with and without S9 mix. The positive controls induced the appropriate responses in the corresponding strains.

A biologically relevant increase in the number of his+ or trp+ revertants was not observed in the standard plate test or in the preincubation test either without S9 mix or after the addition of a metabolizing system. Thus, under the experimental conditions of this study, the test substance is not mutagenic in the Salmonella typhimurium/ Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.

Justification for selection of genetic toxicity endpoint
GLP and guideline compliant study.

Short description of key information:
The test substance did not produce evidence or a concentration related positive response of induced mutant colonies over background (BASF SE, 2015)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance does not need to be classified and labelled under Regulation (EC) No 1272/2008, as amended for the sixth time in Directive EC 605/2014.