Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The substance is considered to be non-mutagenic in the bacterial reverse mutation test.

The bacterial reverse mutation test conducted with Salmonella typhimurium strains supports the conclusion that the substance is non-mutagenic at concentration from 0.01 to 5.0 mg/plate

The chromosome aberration test (in-vitro) shows chromosomal aberrations in cultured cells at a concentration of 5,000 µg/ml.

In the in-vivo mammalian erythrocyte micronucleus test none of the experimental groups treated with the test item showed an increase in MPCEs (micro-nucleated polychromatic erythrocytes). The test item is therefore considered to be non-mutagenic in the mouse bone marrow micronucleus test.

Based on these results, it can be concluded that the positive in vitro findings for chromosomal aberration are overruled by the overall weight of evidence of negative in vivo and other in vitro test for this endpoint.


Short description of key information:
Bacterial reverse mutation test (in-vitro): non-mutagenic
Chromosome Aberration Test (in-vitro): test item induces chromosomal aberrations in cultured cells at a concentration of 5000µg/ml
Mammalian Erythrocyte Micronucleus Test (in-vivo): non-mutagenic

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The test item needs not to be classified since the positive in-vitro findings for chromosomal aberration are overruled by the overall weight of evidence of negative in- vivo and other in vitro tests.