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Key value for chemical safety assessment

Additional information

For the linear analogue octan-1-ol, two bacterial mutagenicity studies are available, in one of which only two strains were tested. The key study for this endpoint is therefore the older study. Both results were negative. For endpoints where there is no information on octan-1-ol, 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.


Short description of key information:
Measured data are not available for 2-methyl-1-heptanol, therefore measured data for structurally analogous alcohols are read across.

In vitro information:
Gene mutation (Bacterial reverse mutation assay / Ames test): negative with and without activation (similar to OECD TG 471) typhimurium strains TA
Cytogenicity in mammalian cells: information not required because in vivo information for a closely related substance is available
Mutagenicity in mammalian cells: the related substance 2-ethylhexan-1-ol was negative with and without activation in L5178Y mouse lymphoma cells (similar to OECD TG 476)

In vivo
Chromosome aberration study in rats: the related substance 1-dodecanol was negative in mice after oral administration (gavage) (similar to OECD TG 475)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Octan-1-ol 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 two studies for octan-1-ol [Ames]. Evidence from in vivo studies on other category members supports the conclusion that these alcohols are not genotoxic in vivo. Negative data of reliability 1 or 2 in support of this conclusion are available for 2-ethyl hexanol (supporting) [negative chromosome aberration assay] and dodecan-1-ol [negative micronucleus assay].