Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

No mutagenic effects have been observed in two Bacterial Reverse Mutation Assays. The study by Hoechst (1982) is considered to be of higher quality (reliability 2), because they used all tester strains required in the guideline OECD 471 and performed testing up to concentrations were cytotoxicity was observed. The study by Zeiger et al. (1992) is not reliable (reliability 3), as bacterial strains Salmonella typhimurium TA102 or E. coli WP2 were not included in the test.


Justification for selection of genetic toxicity endpoint
Well-performed study with a complete set of tester strains according to actual guideline (OECD 471).

Short description of key information:
No mutagenic effects have been observed in two Bacterial Reverse Mutation Assays (Ames test).

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

In a reliable set of bacterial reverse mutation assays the test item is considered to be non-mutagenic.

Based on the available data no classification according to Regulation (EC) No. 1272/2008 and Council Directive 67/548/EEC on mutagenicity is necessary.