Registration Dossier

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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.