Registration Dossier
Registration Dossier
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EC number: 203-366-1 | CAS number: 106-14-9
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional 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.
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