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In Vitro:

A suite of in vitro mutagenicity studies were conducted on alcohols, C18-22, distillation residues (CAS No. 1160164-88-4), including the Ames test, in vitro mouse lymphoma assay and the CHO chromosome aberration assay. All these in vitro studies were negative for mutagenicity.

 

A GLP compliant OECD 471 bacterial reverse mutation assay was conducted with alcohols, C18-22, distillation residues (CAS No. 1160164-88-4). Revertant colonies were assessed following treatment with 6 / 20 / 60 / 200 / 600 / 2000 µg/plate of the test item in the absence and presence of S9 metabolic activation. It was concluded that the test item was not mutagenic in strains of Salmonella typhimurium and Escherichia coli, when tested in the absence and presence of metabolic activation up to and beyond its limit of solubility in the test system.

The mammalian cell gene mutation potential of alcohols, C18-22, distillation residues (CAS No. 1160164-88-4) was assessed in mouse lymphoma L5178Y cells. The test item was tested in the presence and absence of metabolic activation at doses of 25, 50, 100 and 200 µg/ml (not cytotoxic but up to precipitating concentrations). Alcohols, C18-22 distillation residues are not mutagenic in mouse lymphoma L5178Y cells, in either the absence or the presence of S9 mix, when tested in dimethylsulphoxide up to and beyond its limit of solubility in the test system.

A GLP compliant OECD 473 Chromosomal Aberrations Assay with Chinese Hamster Ovary Cell Cultures in vitro was conducted with alcohols, C18-22, distillation residues (CAS No. 1160164-88-4). It was concluded that alcohols, C18-22 distillation residues were not clastogenic when tested with Chinese hamster ovary cells in vitro, when tested up to a concentration of 200 µg/mL.

On the basis of the consistently negative study results from the in vitro genotoxicity data available (above), alcohols, C18-22 distillation residues are non-genotoxic.

Short description of key information:
In Vitro

- Ames (OECD 471): Negative (+/- metabolic activation)

- In vitro mouse lymphoma assay (OECD 476): Negative (+/- metabolic activation)

- Chinese Hamster Ovary cell chromosome aberration assay (OECD 473): Negative (+/- metabolic activation)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

These findings do not warrant the classification of alcohols, C18-22, distillation residues as genotoxic under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.