Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Justification for the read-across approach using (Tetrapropenyl succinimido)-caproic acid as supporting substance:

The registration substance (Pentapropenyl succinimido)-caproic acid and proposed supporting substance (Tetrapropenyl succinimido)-caproic acid are homolog series of (Polypropenyl succinimido)-caproic acid. The only structural difference is that the alkyl moiety of the registratoin substance is composed of five propylen unit, whereas that of the supporting substance is composed of four propylen unit. The given structural difference is not likely to be associated with significantly deviating chemical reactivity, thus is not likely to be associated with significantly deviating reactivity with genetic materials.

Evaluation of the genotoxicity of the registration substance

The read-across supporting 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 may be able 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 test substance bioavailbility to the bone marrow cells was given. Overall, no significant genotoxicity can be assigned for the read-across supporting substance based on the available data. Likewise 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 assessment is based on the read-across approach. The overall assessment on the read-across substance leads to the conclusion that the registration substance is not likely to be genotoxic.

No classification is warranted.