Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The substance was tested in the Ames S. typhimurium bacterial gene mutation assay (2 studies available), the invitro genemutation assay in mammalian cells (HPRT test in CHO cells) and thein vitrochromosomal aberration test in mammalian cells (CHO cells and CHL/IU cells). All test were performed in accordance with current guidelines and under GLP with and without a metabolic activation system. The test substance consistently did not show any genotoxic activity in these test systems and is therefore concluded to be non-genotoxic. This was also confirmed in a 2 -year rat carcinogenicity assay in which no test substance related increases in tumor incidences compared to controls were observed


Justification for selection of genetic toxicity endpoint
All referenced studies are relevant for the endpoint and need to be considered

Short description of key information:
The substance did not induce gene mutations or chromosomal; aberrations in any of the 3 standard valid in vitro genetic toxicity tests that were performed according to recent guidelines and under GLP. Two additional studies available in the public domain confirmed the negative results.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The substance was tested in the Ames S. typhimurium bacterial gene mutation assay (2 studies available), the invitro genemutation assay in mammalian cells (HPRT test in CHO cells) and thein vitrochromosomal aberration test in mammalian cells (CHO cells and CHL/IU cells). All test were performed in accordance with current guidelines and under GLP with and without a metabolic activation system. The test substance consistently did not show any genotoxic activity in these test systems and is therefore concluded to be non-genotoxic. This was also confirmed in a 2 -year rat carcinogenicity assay in which no test substance related increases in tumor incidences compared to controls were observed.

Consequently the substance is not classified for germ cell mutagenicity according to Regulation EC 1272/2008 and amendments.