Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

A bacterial reverse mutation assay (Ames test) has been performed on Ethylene glycol dimethyl ether covering the strains Salmonella typhimurium TA98, TA100, TA1535, TA1537, TA1538 and E. coli WP2 uvr A. There was no increase in the number of revertant colonies with any of the tester strains.

 

In two mammalian cytogenicity studies the genotoxic potential of Ethylene glycol dimethyl ether was examined in vitro using Chinese hamster cells for the detection of sister chromatid exchanges and the permanent human cell line A549 for determination of unscheduled DNAsynthesis, negative results in the absence of metabolic activation were obtained for the human cell line and positive in case of the Chinese hamster cells. Ethylene glycol dimethyl ether did not induce chromosome aberrations at 2000 mg/kg bw in an in vivo Mammalian Bone Marrow Chromosome Aberration test performed with hamsters similar to OECD475. Furthermore, Ethylene glycol dimethyl ether is considered to be non-mutagenic in mice in the micronucleus test applying dosages up to 2000 mg/kg d (at 2 applications on 2 consecutive days).


Short description of key information:
- Ames test: negative
- in vitro SCE test: positive (restricted reliability)
- in vitro UDS assay: negative (2 studies)
- in vitro gene mutation test: negative
- in vivo micronucleus test in mice: negative
- in vivo Chromosome Aberration study in hamsters: 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 Ethylene glycol dimethyl ether and therefore classification for this end point is not warranted.