Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Additional information

No carcinogenicity data are available for lysmeral.

According to REACH, additional data on carcinogenicity need to be provided if the substance has a widespread dispersive use or frequent/long-term human exposure is given and the substance is a mutagen category 3 or there is evidence for a capacity to induce hyperplasia and/or preneoplastic lesions from repeated dose studies.

Based on the available genotoxicity data in vitro and in vivo, lysmeral was found to be non-mutagenic and non-clastogenic. Additionally, there is no evidence from repeated dose studies that the substance is able to induce hyperplasia and/or pre-neoplastic lesions.

As a consequence, there is no indication for further testing lysmeral in a carcinogenicity study.

Justification for classification or non-classification