Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

4 bacterial reverse mutation assays (Ames test) have been performed on Diethylene glycol dimethyl ether covering the strains Salmonella typhimurium TA98, TA100, TA1535, TA1537, TA1538. There was no increase in the number of revertant colonies with any of the tester strains.

The human embryonic intestinal fibroblasts were used for determination of unscheduled DNAsynthesis induced by Diethylene glycol dimethyl ether. Negative results in the absence and presence of metabolic activation were obtained for the human cells and positive in case of the Chinese hamster cells. Diethylene glycol dimethyl ether did not induce chromosome aberrations up to 1000 ppm in an in vivo Mammalian Bone Marrow Chromosome Aberration test performed with rats similar to OECD475.With reference to the known spermatotoxic/reproductive toxic properties of Diethylene glycol dimethyl ether (the substance is classified as reproductive toxicant Cat. 2, please refer to Chapter 7.8.3) the effects observed in an in vivo dominant lethal assay performed in rats are more likely to be due to the impairment of fertility than the result of a genotoxic mechanism.


Short description of key information:
- Ames test: negative (4 studies)
- in vitro UDS assay: negative (1 study)
- in vivo dominant lethal assay in rats: not applicable since the substance is toxic to the male reproductive system
- in vivo Chromosome Aberration study in rats: negative

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

It can be concluded from the data available that mutagenicity and genotoxicity are not caused by Diethylene glycol dimethyl ether and therefore classification for this end point is not warranted.