Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The substance was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of several bacterial strains, i.e. Salmonella typhimurium (TA 1535, 100, 1537, 98) and Escherichia coli (WP2 uvrA), in a reverse mutation assay. The test item was applied at concentrations from 33 - 5250 ug/plate in a pre-incubation test and a standard plate test in presence and absence of a metabolic activation system (beta-naphthoflavone/phenobarbital induced rat liver S9 mix). Precipitation of the test substance was found from about 333 μg/plate onward with and without S9 mix. No bacteriotoxic effect was observed. A 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 material is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.


Short description of key information:
The substance was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of several bacterial strains, i.e. Salmonella typhimurium (TA 1535, 100, 1537, 98) and Escherichia coli (WP2 uvrA), in a reverse mutation assay according GLP and OECD guideline 471. A 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. The test item is therefore not considered to be mutagenic in the Ames test.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for genotoxicity under Directive 67/548/EEC, as amended for the 30th time in Directive 2008/58/EC.

 

 

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for genotoxicity under Regulation (EC) No. 1272/2008, as amended for the second time in Directive (EC 286/2011).