Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Carcinogenicity

Currently viewing:

Administrative data

Description of key information

A data waiver has been submitted for this endpoint.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In accordance with criteria for classification as defined in Annex I, Regulation 1272/2008, the substance does not require classification for carcinogenicity.

In accordance with the criteria for classification as defined in Annex VI, Directive 67/548/EEC (DSD) the substance does not require classification for carcinogenicity.

Additional information

According to column 2 (specific rules for adaptation from column 1) point 8.9.1, under Annex X of Regulation 1907/2006, a study may be proposed 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 the repeated dose study(ies) that the substance is able to induce hyperplasia and/or pre-neoplastic lesions.

 

As the substance was found to be non-mutagenic from the conclusions of the genetic toxicity tests, and no neoplastic histopathology was noted in the repeated dose studies, and there are no such known reports in humans in the public domain, testing for this endpoint is not proposed.