Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Reverse mutation assay:

The test item 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 and Escherichia coli, in a reverse mutation assay. The following strains were used: TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA . The dose range was: 0.8 µg - 5000 µg/plate (SPT; Salmonella strains); 4.0 µg - 5000 µg/plate (SPT; E. coli); 3.125 µg - 50 µg/plate (PIT; Salmonella strains); 4.0 µg - 1000 µg/plate (PIT; E. coli). Standard plate test (SPT) and preincubation test (PIT) both with and without metabolic activation (Aroclor-induced rat liver S-9 mix) was carried out. No precipitation of the test substance was found. A bacteriotoxic effect was observed depending on the strain and test conditions from about 20 µg - 500 µg/plate onward. An increase in the number of his+ or trp+ revertants was not observed in the standard plate test or in the preincubation test either without S-9 mix or after the addition of a metabolizing system. Thus, under the chosen conditions, the test substance did not lead to an increase in the number of revertant colonies either without S-9 mix or after adding a metabolizing system.

Justification for selection of genetic toxicity endpoint
GLP and guideline study

Short description of key information:
The genetic toxicity of the test item was determined in an Ames test according to OECD guideline 471. No mutagenic potential was found.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

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

The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the test substance is not considered to be classified for genetic toxicity under Regulation (EC) No 1272/2008, as amended for the seventh time in Regulation (EU) No 2015/1221.