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Administrative data

Key value for chemical safety assessment

Additional information

The potential of the registered substance to cause gene mutation in bacterial strains was determined following a methodology similar to that outlined in the standardised guideline OECD 471. During the study, four strains of Salmonella typhimurium (TA98, TA100, TA1535, TA1537) and one strain of Escherichia coli (WP2uvrA-) were treated in the presence and absence of a rat liver derived metabolic activation system (S9 mix). In two separate assays, the test material did not induce any significant increases in the number of revertant colonies, in any of the tester strains, either in the presence or absence of S9 mix.

An in vitro mammalian cell mutagenicity test was not available for the registered substance. An OECD 473 is available for the analogous substance, CAS# 61789-01-3.The potential of the test material to cause gene mutation in mammalian strains was determined following a methodology similar to that outlined in the standardised guideline OECD 473. During the study, Chinese Hamster Lung Fibroblasts (V79) were treated in the presence and absence of a rat liver derived metabolic activation system (S9 mix).In both independent experiments, neither a statistically significant nor a biologically relevant increase in the number of cells carrying structural chromosomal aberrations was observed after treatment with the test item. No relevant increase in the frequencies of polyploid metaphases was found after treatment with the test item as compared to the frequencies of the controls.


Justification for selection of genetic toxicity endpoint
The registered substance was negative in an OECD 471 and an analogous substance was negative in an OECD 473.

Short description of key information:
Negative in two studies

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

In accordance with with criteria for classification as defined in Regulation 1272/2008, the test material does not require classification for mutagenicity as no signs of toxicity were observed.