Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Genetic toxicity in vitro:

Ames test: negative with metabolic activation ; negative without metabolic activation: In this study the test substance was found to have no mutagenic effects on Salmonella typhimurium strains TA 1537, TA 98, TA 100, TA 1535 and Escherichia coli WP2 (uvrA) with (+) and without (-) the metabolic activation system S9 from male Wistar rats.

Chromosome aberrations: It can be stated that under the experimental conditions reported, the test item did not induce structural chromosome aberrations in V79 cells (Chinese hamster cell line) when tested up to cytotoxic concentrations (Experiment II without S9 mix) or the highest scorable concentrations (Experiment I with and without S9 mix and Experiment II with S9 mix).

Gene mutation in mammalian cells: Under the conditions of this study, the test item did not induce gene mutations in presence and absence of metabolic activation in the cultured mammalian cells (L5178Y TK+/- 3.7.2 C mouse lymphoma cell line) used.

Short description of key information:
Genetic toxicity in vitro:
Ames test: OECD guideline 471 and EU method B.13/14. GLP.
Chromosome aberrations: OECD guideline 473. GLP.
Gene mutation in mammalian cells: OECD guideline 476 and EU method B.17.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available data, the substance is not classified.