Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Justification for classification or non-classification

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.