Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Based on the available data, no structural alerts and no indications for a carcinogenic potential are identified.

Key value for chemical safety assessment

Justification for classification or non-classification

Based on the overall weight of evidence, the available data on the carcinogenic potential of the substance are conclusive but not sufficient for classification according to DSD (67/548/EEC) and CLP (1272/2008/EC) criteria.

Additional information

This information is not available for any member of the Vinasses category.

According to the REACh regulation (1907/2006/EC), a carcinogenicity study may be proposed by the registrant or may be required by the Agency in accordance with Articles 40 or 41 if the substance has a widespread dispersive use or there is evidence of frequent or long-term human exposure, and the substance is classified as mutagen category 3 or there is evidence from repeated dose studies that the substance is able to induce hyperplasia and/or pre-neoplastic lesions.

There is no evidence, that any member of the Vinasses category causes carcinogenicity by a direct genotoxic mechanism as the results of the available in vitro and in vivo genotoxicity studies (mutagenicity and cytogenicity) were negative. Moreover, in the available subacute and subchronic repeated dose toxicity studies no evidence for hyperplasia or preneoplastic lesions was seen.