Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

There is no information available for C9, 10 and 11 lcohols; predominantly linear, so 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:
In vitro information:
Gene mutation (Bacterial reverse mutation assay / Ames test): the related substance C7, 8 and 9 Alcohols; predominantly linear: negative with and without activation in S. typhimurium strains TA 98, TA100, TA1535 and TA1537 (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 2-ethylhexan-1-ol: 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 dodecan-1-ol was negative in mice after oral administration (gavage)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

C9, 10 and 11 alcohols; predominantly linear 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. 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].