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Administrative data

Key value for chemical safety assessment

Additional information

Bacterial reverse mutation assays (Ames test) have shown the structurally related substances not to induce reverse mutation in Salmonella typhimurium or Escherichia coli. In addition, structural analogues of the substance neither induced chromosomal aberrations in Chinese hamster ovary cells after in-vitro treatment nor induced mutation in mouse lymphoma L5178Y cells.

 

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 substancs 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.


Short description of key information:
Genetic toxicity in-vitro - Negative, based on several studies available on structurally related substances.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

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