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Additional information

Mutagenicity of 1,4 -cyclohexane dimethanol divinyl ether was tested in a bacterial reverse mutation GLP study according to japanese guidelines for Screening Mutagenicity Testing Of Chemicals. The Strains TA 98, TA100, TA1535, TA1537 and Ecoli WP2uvr were used. Due to cytotoxicity the test was performed in concentration range from 0.6 to 78 µg/plate witout S9 -Mix and 2.4 to 625 µg/plate with metabolic activation. Positive and solvent controls gave the expected results. No mutagenic activity of the test compound was found under the conditions of the test.

Mammalian gene mutation (HGPRT locus) of dimethylol-1,4-cyclohexane divinylether was tested with and without metabolic activation in Chinese hamster ovary cells (CHO). The concentration rang tested was 5-50 µg/ml (without metabolic activation) and 60-400 µg/ml (with metabolic activation by S9-Mix). Higher concentrations appeared to be cytotoxic in a dose range finding study. No induction of forward mutations was observe in any of the experiments. Positive and negative controls gave the expected results.

Beyond this, mutagenicity of dimethanol-1,4 -cyclohexane divinylether was investigated in a in-vivo micronucleus test in mice according to OECD no. 474. 5 male and  female mice per dose and time point received a single oral doses of 0, 300, 600 and 1200 mg/kg 1,4 dimethanol cyclohexane divinylether in corn oil. Erythrocytes from bone marrow were harvested  24, 48 and 72 h post application. There was no induction of micronucleus formation. From a dose dependent decrease of the PCE/NCE ration it can be concluded that test substance has reached bone marrow cells. Mortality and lethargy of animal receiving 1200 mg/kg demonstrate that the maximal tolerable oral dose was tested. Negative and positive controls gave expected results. Dimethanol-1,4 -cyclohexane divinylether is considered non-klastogenic in-vivo.


Short description of key information:
No mutagenic activity of dimethanol 1,4 cyclohexane divinylether was observed in tests with bacteria, mamalian cell culture and in vivo in mammals.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Classification for genetic toxicity is not warranted according to the criteria of EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.