Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Bacterial reverse mutation assay (Ames) is in progress and expected to be negative.

Mammalian cell gene mutation test (HPRT method): negative

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

An AMES test on the target substance is in progress.

The results of the available HPRT assay performed according to OECD guideline 476 on the target substances were also reported.

Chinese hamster V79 cells were treated with test substance dissolved in DMEM. Three cytoxicity experiments were run to assess the optimal dose range; tested concentrations ranged for 0.0005 to 2 mg/ml. Based on cytotoxicity results, concentrations for main test with and without metabolic activation (S9-mix) were chosen. In particular:

- 0.01, 0.015, 0.02 (discarded as redundant), 0.025, 0.03 and 0.04 mg per ml without S9 -mix

- 0.02, 0.05, 0.075, 0.1 nad 0.2 (discarded as completely toxic) mg per ml with S9 -mix.

Positive and negative controls were valid.

Under test conditions, test substance resulted as non mutagenic in this assay.

Justification for classification or non-classification

Based on currently available data, i.e. expected negative Ames assay, negative HPRT assay target substance is considered as not mutagenic.