Octadecane-1,12-diol

Endpoint summary

Additional information

A bacterial reverse mutation assay (plate incorporation) was conducted similar to OECD 471 and in compliance with GLP. S typhimurium strains TA 1535, 1537, 98, 100, and 1538 were exposed to 8, 40, 200, 1000, and 5000 µg/plate test substance in the first experiment and to 6.25, 25, 100, 400, and 1600 µg/plate in the second experiment with and without metabolic activation (Aroclor-induced rat liver S-9 mix). E coli or S typhimurium strain TA 102 were not used in this experiment. No toxic effect was noted up to 5000 µg/plate. Precipitation of the test substance was visible at a concentration of 200 µg/plate or higher. No enhanced revertant rates compared to the concurrent negative controls, induced by the test substance were observed in all tested strains, of S. tymphimurium in this mutagenicity test, neither with nor without metabolic activation. Therefore, under the condition of this study the test substance is considered not to be mutagenic.

 

A study was conducted to investigate the potential of the test substance to induce gene mutations at the HPRT locus in V79 cells of the Chinese hamster. This study was conducted according to OECD 476 and in compliance with GLP. The study was performed in two independent experiments, using identical experimental procedures. Cells were exposed for 4 hours with and without metabolic activation (Phenobarbital/β-naphthoflavone induced rat liver S9). The concentration range of the main experiments was limited by cytotoxicity and precipitation of the test item. The test item was dissolved in DMSO. In the first experiment concentrations of 0.22, 0.44, 0.88, 1.8, and 3.5 µg/mL test substance without metabolic and 35.0, 70.0, 140.0, 280, and 560.0 with metabolic activation were analyzed to determine the mutation rate. In the second experiment concentrations of 0.25, 0.5, 1.0, 1.5, and 2.0 µg/mL test substance without metabolic and 1.6, 4.7, 14.0, 28.0, and 42.0 with metabolic activation were analyzed. No substantial and reproducible dose dependent increase of the mutation frequency was observed up to the maximum concentration with and without metabolic activation. Appropriate reference mutagens (ethylmethane sulfonate and 7,12-dimethylbenz(a)anthracene), used as positive controls, induced a distinct increase in mutant colonies and thus, showed the sensitivity of the test system and the activity of the metabolic activation system. Under the conditions of this study the test item did not induce gene mutations at the HPRT locus in V79 cells. Therefore, under the conditions of this study the test substance is considered to be non-mutagenic.

Short description of key information:
The available Ames test (OECD471 and GLP complaint) was negative for mutagenicity and is adequate for assessment, however E coli or S typhimurium TA 102 strains were not tested. Additionaly, several QSAR prediction were made, which were all negative. Furthermore, an HPRT assay is available (OECD 476 and GLP compliant) and was negative for mutagenicity.
For chromosome aberration QSAR predictions were mad which also showed no gentotoxic potential.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

There are no sufficient data available for classification according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.