Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The available information is derived from reliable studies. No other data were available for this substance. The results of both the studies were in agreement. Further in vitro testing is not considered necessary as the substance is used as an intermediate under highly controlled conditions. In vivo testing is not required as no evidence for genetic toxicity was found in the in vitro studies.

Short description of key information:
In vitro:
Gene mutation (Bacterial reverse mutation assay / Ames test): negative with and without activation in all strains tested (OECD TG 471)
Cytogenicity in mammalian cells: negative in cultured human lymphocytes (OECD TG 473)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The available information for the substance indicates that, when tested in vitro,
CNE does not induce mutations in bacterial cells, nor chromosome aberrations in mammalian cells. There is no justification fromin vitroresults for testingin vivo. Therefore, it is considered that classification for mutagenicity is not required.