Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Evaluation of the genotoxicity of the registration substance

The registration substance is not mutagenic in Ames test, not mutagenic in HPRT test. It is however clastogenic in in-vitro chromosome aberration test and not clastogenic in in-vivo chromosome aberratoin test.

The observed clastogenicity in in-vitro assays may be related to the highly branched alkyl moiety that thus to the ability to form stabilized radical species. This property is certainly linked to the technical profile in that the substance is used as corrosion inhibitor. In the in-vivo chromosome aberration assay no clastogenic acitivity was found in the bone marrow of orally treated mice. The study is valid, since cytoxicity was found in the bone marrow cells, demonstrating the bioavailbility to the bone marrow cells were given. Overall, no significant genotoxicity property can be derived for the registration substance.

Justification for selection of genetic toxicity endpoint
Four studies are available. All studies are considered to be equally valid.

Short description of key information:
The registration substance is not genotoxic.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The registration substance is not genotoxic based on three in-vitro studies and one in-vivo study.

No classification is warranted.