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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Key value for chemical safety assessment

Additional information

Short description of key information:
Not considered to be genotoxic

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

12-hydroxystearic acid did not exhibit mutagenic activity in variousin vitro studies, including a bacterial reverse mutation (Ames) assay, amammalian cell gene mutationassay and a chromosome aberration test with Chinese hamster ovary cells.


The above evidence, added to the long history of safe use of the substance in cosmetic and industrial uses, suggests that 12-hydroxystearic acid does not have a mutagenic potential.


Based on the above information, the substance does not qualify for mutagenicity classification according to Directive 67/548 EC or Regulation 1272/2008/EC.