Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

There was no information available on the genetic toxicity of Reaction mass of 2-butylheptan-1-ol and 2-ethylnonan-1-ol and 2-methyldecan-1-ol and 2-propyloctan-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.

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 C7, 8 and 9 Alcohols; predominantly linear: negative with and without activation in S. typhimurium strains TA 98, TA100, TA1535 and TA1537 (similar to OECD TG 471)
Gene mutation (Bacterial reverse mutation assay / Ames test): the related substance C12 and 13 alcohols; linear and monobranched, type 2:: negative with and without activation in S. typhimurium strains TA 98, TA100, TA1535, TA1537 and TA 1538 (similar to 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 was negative with and without activation in L5178Y mouse lymphoma cells (similar to OECD TG 476)

In vivo
Mouse micronucleus study: the related substance dodecan-1-ol was negative in mice after oral administration (gavage) (OECD 474)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Reaction mass of 2-butylheptan-1-ol and 2-ethylnonan-1-ol and 2-methyldecan-1-ol and 2-propyloctan-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), including branched alcohols, are negative. Evidence from in vivo studies on category members supports the conclusion that these alcohols are not genotoxic in vivo.