Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The substance was investigated in a Bacterial Reverse Mutation (Ames) Test according to OECD TG 471 in doses up to and including 5000 µg/plate on Salmonella typhimurium TA 1535, TA 100, TA 1537, TA 98, and TA 102. None of the doses caused any bacteriotoxic effect. Substance precipitation occurred at the dose of 5000 μg per plate. No biologically relevant increase in the mutant count, in comparison to the negative controls, was observed in any of the strains tested, without and with S9 mix, under the experimental conditions applied.

The substance was tested in an in vitro gene mutation assay (HPRT) in V79 cells according to OECD TG 476. The assay was performed in two independent experiments. The first main experiment was performed with and without liver microsomal activation and a treatment period of 4 hours. The second experiment was performed with a treatment time of 4 hours with and 24 hours without metabolic activation. The highest applied concentration in the pre-experiment (2500 μg/mL) was limited by the solubility properties of the test item in the vehicle DMSO and aqueous medium. The dose range of the main experiments was limited by precipitation of the test item in aqueous medium.

No substantial and reproducible dose dependent increase of the mutation frequency was observed in both experiments. Thus, it can be stated that under the experimental conditions the test item did not induce gene mutations at the HPRT locus in V79 cells. The test item was examined for mutagenic activity (chromosome breakage and misdistribution of chromosomes) in the in vitro micronucleus test using Chinese Hamster V79 cells in accordance to OECD Guideline 487. The negative/solvent control and appropriate positive controls with known mutagens demonstrated the suitability and sensitivity of the test system.

The test item showed no biologically relevant increase in the frequency of micronucleus containing V79 cells in the absence (4 hours or 24 hours treatment) or in the presence of S9 mix (4 hours treatment) when tested up to cytotoxic or precipitating concentrations.

Justification for selection of genetic toxicity endpoint
No study selected since all in vitro studies were negative.

Short description of key information:
Ames Test: negative
HPRT Test: negative
In vitro Micronucleus Test: negative

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

No classification on genetic toxicity warranted according to Regulation (EC) No 1272/2008, Annex I.