Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The four in-vitro studies were cytogenicity on human lymphocytes, the bacterial reverse mutation AMES test, the mammalian cell gene mutation test, and the unscheduled DNA synthesis test. The one in-vivo test conducted was the micronucleus test. All tests were rated Klimisch 1, and gave negative results on genotoxicity of the test item.

Short description of key information:
Five studies on genetic toxicity on undecylenic acid were carried out in the years 1988 and 1989. Four in vitro GLP tests were performed according to corresponding OECD guidelines for the ames test, the cytogenicicty test, the in vitro mammalian cell gene mutation and the in vitro DNA repair assay. In vivo, a micronucleus test was performed in the mice according to GLP and OECD guideline. All tests gave negative results on genotoxicity of the test item.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Since all genotoxicity tests gave negative results, no classification of undecylenic acid is warranted for genotoxicity properties according to EU regulation (EC) No 1272/2008 (CLP) andto EU Directive 67/584/EEC.