Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Description of key information

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 vivo studies available for structurally related substances are also negative.

Additional information

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 were negative and in vivo studies available for structurally related substances are also negative, so performance of additional in vivo studies is regarded as inappropriate and not in line with current concerns regarding animal welfare and the use of animals in scientific experiments.

Also confirmed by Scientific Bodies (EU RAR, 2004; SCOEL, 2009; EFSA, 2010, 2016).

Justification for classification or non-classification

Non-classification is justified on the basis of negative findings in the Ames tests and in separate in vitro and in vivo tests for gene mutation / mutagenicity with structuraly related substances.