Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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 analogue substance are conclusive but not sufficient for classification according to DSD (67/548/EEC) and CLP (1272/2008/EC) criteria.

Therefore, using the principle of read-across, Vinasses, residue of fermentation, depotassified is not classified according to DSD (67/548/EEC) and CLP (1272/2008/EC) criteria.

Additional information

This information is not available for the analogue substance (Vinasses).

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 the analogue substance 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.