Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Structural analogues of the substance have been tested in bacterial reverse mutation assays (Ames test) which showed the substance(s) not to induce reverse mutation in Salmonella typhimurium or Escherichia coli, an in-vitro chromosome aberration test which showed the substance not to induce chromosomal aberrations; an assay for the induction of trifluorothymidine resistant mutants in mouse lymphoma L5178Y cells after in vitro treatment which was negative and an assay for the ability to induce micronuclei in Chinese hamster V79 cells following in vitro treatment which was negative.

 

REACH Regulation 1907/2006 (Annex VIII, 8.4 Column 2) states that appropriate in-vivo mutagenicity studies should be considered in those cases of a positive result in any of the in vitro genotoxicity studies. In vitro investigations with the substance were negative and in vivo studies are therefore regarded as inappropriate and not in line with current concerns regarding animal welfare and the use of animals in scientific experiments.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Non-classification is justified on the basis of negative findings in a number of in-vitro tests on the substance