Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

One study is recorded for this endpoint and was chosen as a key study. The potential of the substance to induce reverse mutation in bacteria was assessed using five strains of Salmonella typhimurium and Escherichia coli Wp2uvrA according to a method comparable to OECD guideline 471. The study was conducted in compliance with the principles of Good Laboratory Practice.

The substance was tested in two independent experiments, with and without a metabolic activation system, both performed according to the direct plate incorporation method. Bacteria were exposed to the substance at six dose-levels (three plates/dose-level) selected from a preliminary toxicity test. In both experiments, the dose-levels ranged from 4 to 5000 μg/plate for all strains, with and without S9 mix. After 48 to 72 hours of incubation, the revertant colonies were scored.

The number of revertants for the vehicle and positive controls was as specified in the acceptance criteria. The study was therefore considered valid.

The substance did not induce any significant increase in the number of revertants, both with and without S9 mix, in any of the five strains of Salmonella typhimurium and Escherichia coli WP2uvrA.

The substance was considered to be non-mutagenic under the conditions of this test.


Short description of key information:
The potential of the substance to induce gene mutation in bacteria was investigated using a gene mutation assay on Salmonella typhimurium TA 1535, TA 1537, TA1538, TA 98, TA 100 and on E. Coli WP2uvrA (method equivalent to OECD guideline 471, GLP).
The test item was found to be not mutagenic in this assay.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The substance is not mutagenic in the vitro gene mutation test in bacteria. However and according to the criteria laid down in EU regulation (EC) n° 1272/2008 (CLP) and the EU directive 67/548/EEC, the substance cannot be classified for genetic toxicity on a basis of a sole gene mutation test in bacteria.