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Key value for chemical safety assessment

Additional information

Information is available for C12 and 13 alcohols; linear and monbranched from a reliable study on bacterial mutagenicity. In addition, there is information from studies of lower reliability on cytogenicity in cultured rat liver cells, and gene conversion in Saccharomyces cerevisiae. The results of all these studies were negative. For endpoints where there is no information on C12 and 13 alcohols-branched and linear, key studies were chosen from studies on closely related linear or branched alcohols of similar chain length. The choice of key 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): negative with and without activation in S. typhimurium strains TA 98, TA100, TA1535, TA1537 and TA 1538, and E. coli WP2 and WP2 uvrA (OECD TG 471)
Cytogenicity in mammalian cells: the related substance C10-16 alcohols (67762-41-8): negative in CHO cells (OECD TG 473)
Mutagenicity in mammalian cells: the related substance 2-ethylhexan-1-ol: negative with and without activation in L5178Y mouse lymphoma cells (similar to OECD TG 476)
Mutagenicity in mammalian cells: the related substance Docosan-1-ol was negative with and without activation in CHL V79 cells (similar to OECD TG 476)

In vivo
Chromosome aberration study in rats: the related substance dodecan-1-ol was negative in mice after oral administration (gavage)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

C12 and 13 alcohols, linear and monobranched, 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 including a bacterial mutagenicity study on C12 and 13 alcohols, linear and monobranched. Evidence from in vivo studies on other category members supports the conclusion from in vitro studies that these alcohols are not genotoxic. Negative data of reliability 1 or 2 in support of this conclusion are available for 2-ethyl hexanol (supporting) [negative chromosome aberration assay] and 1-dodecanol [negative micronucleus assay].

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