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Key value for chemical safety assessment

Additional information

There is no information on the genetic toxicity of C16 -17 alcohols, linear and branched, so key studies were chosen from studies on closely related linear or branched alcohols of similar chain length, including a study on a branched alcohol. The choice of read-across study was based on reliability and similarity of chain length. The data available from standard in vitro and in vivo genetic toxicity assays for all related substances show no evidence of mutagenic potential.

In some cases the CAS and chemical identity stated refer to SDA nomenclature for this substance. In REACH substance identification it is necessary to be more specific as to the chain lengths present. Full details may be found in the CSR.


Short description of key information:
In vitro information:
Gene mutation (Bacterial reverse mutation assay / Ames test): the related substance C12, 13, 14 and 15 alcohols; linear and monobranched: negative with and without activation in S. typhimurium strains TA 98, TA100, TA102 TA1535 and TA1537 (OECD TG 471)
Gene mutation (Bacterial reverse mutation assay / Ames test): the related substance C16-18 and C18 unsatd was negative with and without activation in S. typhimurium strains TA 98, TA100, TA1535, TA1537 and TA 1538 (OECD TG 471)
Cytogenicity in mammalian cells: the related substance C12 and 13 alcohols; linear and monobranched, type 2: negative in CHO cells (OECD TG 473)Cytogenicity in mammalian cells: the related substance Docosan-1-ol was negative with and without activation in Chinese hamster ovary cells (similar to OECD TG 473)
Mutagenicity in mammalian cells: the related substance Docosan-1-ol was negative with and without activation in Chinese hamster lung V79 cells (similar to OECD TG 476)
Mutagenicity in mammalian cells: the related substance 2-ethylhexanol was negative in mouse lymphoma L5178Y cells (similar to OECD TG 476)
In vivo
Mouse micronucleus study: the related substances dodecanol and docosanol were negative in bone marrow (similar to OECD TG 474)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

C16 -17 alcohols, linear and branched is a member of the category aliphatic alcohols. The category members contain no structural elements which may be of concern for potential mutagenic activity. In vitro tests over the carbon range (C6-22) of the long chain alcohols category members (primary aliphatic alcohols) and supporting substances (C5-C24-34) are negative. Evidence from in vivo studies on other category members supports the conclusion that these alcohols are not genotoxic in vivo.