Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

The submitted genotoxicity studies have been performed with menthone/isomenthone racemic, representing the two main components of the registered reaction mass (up to 90%). The test substance has been found to be not mutagenic in bacteria and mammalian cells and not cytogenic in mammalian cells under the chosen testing conditions.

Overall based on the present data, the reaction mass is considered to have no genotoxic properties. Other components of the reaction mass do not give indications for an impact on the classification of this reaction mass due to its hazard profile.

Endpoint Conclusion:

Justification for classification or non-classification

The present data on genetic toxicity do not fulfill the criteria laid down in 67/548/EEC and regulation (EU) 1272/2008 and therefore, a non-classification is warranted.