Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The Ames test (Reference Thompson & Shanks (2008)) performed according to OCED 471 was rated reliable without restrictions and used as a key study. The results indicate that the test substance under the experimental conditions described, is not mutagenic to Salmonella typhimurium strains TA1535, TA1537, TA98, TA100, and TA 102 in the presence and absence of a metabolising system.

The in-vitro mammalian chromosome aberration test (reference Bohnenberger (2011)) performed according to OCED 473 was rated reliable without restrictions and used as a key study. The test item did not induce structural chromosomal aberrations. Therefore, the test item is considered to be non-clastogenic in the chromosome aberration test.


Short description of key information:
In vitro studies:
Ames test (OECD 471; (GLP compliant): negative
Chromosome aberration test (OECD 473; GLP compliant): negative

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

All available reliable studies showed no genetic toxicity for the test substance. Thus, no classification is required according to Regulation 1272/2008 and subsequent regulations.