Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

A bacterial reverse mutation assay (Ames test) has been performed on Triethylene glycol dimethyl ether covering the strainsSalmonella typhimuriumTA98, 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 unscheduledDNAsynthesis induced by Diethylene glycol dimethyl ether and the permanent human cell line A549 was employed to assess the genotoxic activity of Ethylene glycol dimethyl ether (both structural analogues of Triethylene glycol dimethyl ether). Negative results in the absence and presence of metabolic activation were obtained for the human cells. Ethylene glycol dimethyl ether was not mutagenic to CHO cells in gene mutation assay performed with and without metabolic activation.

Furthermore, Ethylene glycol dimethyl ether (read across) did not induce chromosome aberrations at 2000 mg/kg bw in anin vivoMammalian Bone Marrow Chromosome Aberration test performed with hamsters similar to OECD475, and it 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 UDS assay: negative (2 studies, read across to Ethylene glycol dimethyl ether and Diethylene glycol dimethyl ether)
- in vitro gene mutation assay: negative (read across to Ethylene glycol dimethyl ether)
- in vivo micronucleus test in mice: negative (read across to Ethylene glycol dimethyl ether)
- in vivo Chromosome Aberration study in hamsters: negative (read across to Ethylene glycol dimethyl ether)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

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