Registration Dossier
Registration Dossier
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EC number: 203-924-4 | CAS number: 111-96-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Several genetic toxicity studies have been perfromed, in vitro and in vivo.
There was no indication of mutagenecity in bacteria or mammalian cells and no clastogenic effect in vivo apparent.
Hence, the test substance does not induce genetic toxicity.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
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.
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.
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