Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Mutagenic activity of the test item was investigated in two bacterial reverse mutation assays (Ames test; test strains used:S. typhimurium TA 98, TA 100, TA 1535, TA 1537 and E. coli WP2 uvr A), in an in vitro gene mutation study in mammalian cells (Chinese Hamster V79 cells) and in one in vitro chromosome aberration study in Chinese Hamster V79 cells. Negative results were obtained in all studies with and without metabolic activation.

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

Genetic toxicity in vivo

Description of key information

not mandatory

Endpoint conclusion
Endpoint conclusion:
no study available

Mode of Action Analysis / Human Relevance Framework

no adverse effect observed

Additional information

The test itemshowed negative results in the study for the induction of gene mutations (bacterial reverse mutation assay) by frameshift or base-pair substitutions with and without metabolic activation. The studies were performed with the test strains S. typhimurium TA 98, TA 100, TA 1535, TA 1537 and E. coli WP2 uvr A. Test concentrations up to the limit concentration of 500 µg/plate were tested in the experiment. The test compound proved to be not mutagenic to the bacterial strains.

The test substance also yielded negative results in anin vitrogene mutation study in mammalian cells in concentration up to 20 µg/mL.

The test item was assessed for its potential to induce chromosome aberrations in Chinese Hamster V79 cellsin vitro. The test item did not induce chromosome aberrations. Therefore, it is considered to be non-mutagenic in this in vitro chromosome aberration test when tested up to 10 µg/mL.

In conclusion, the test substance is not mutagenic in the bacterial reverse mutation assay, the in vitro gene mutation study in Chinese V79 and the in vitro chromosome aberration in the presence and absence of metabolic activation up to the tested concentrations.

Justification for classification or non-classification

The test substance salt does not have to be not classified for mutagenicity since this substance did not reveal any mutagenic effect in the bacterial reverse mutation assay in the presence or absence of metabolic activation in concentrations up to 500 µg/plate, in the in vitro gene mutation assay (up to 20 µg/mL) and in the in vitro chromosome aberration study in concentrations up to 10 µg/mL.