Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitising potential of Diethylene glycol methyl ethyl ether was tested in one Local Lymph Node Assay (LLNA) according to OECD test guideline 429. In this assay S.I. of 0.73, 1.03 and 0.69 were determined with the test item at concentrations of 25%, 50% and 100% in acetone:olive oil (4 +1).

In this assay no EC3 value could be calculated since all S.I. values were below 3. Due to structural and toxicological similarity a read across to Ethylene glycol dimethyl ether was performed.

Migrated from Short description of key information:
A read across to Diethylene glycol methyl ethyl ether was performed. Diethylene glycol methyl ethyl ether has been tested in one Local Lymph Node Assay to assess the sensitising potential of the test item. In this assay the Stimulation Indices (S.I.) of 0.73, 1.03 and 0.69 were obtained with test concentrations of 25, 50 and 100% in acetone:olive oil (4+1), respectively.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There are no respiratory sensitization properties of the substance known in literature. Beyond this there is no hint of any sensitization property of the compound from the LLNA study. Therefore, it is concluded that the subsance is not a respiratory sensitizer.


Migrated from Short description of key information:
Based on the existing data it is concluded that the substance is not a respiratory sensitizer.

Justification for classification or non-classification

Ethylene glycol dimethyl ether and Diethylene glycol methyl ethyl ether, which is tested for its sensitising potential, belong to the glycol ether family. These substances have been demonstrated to be very similar in structure, physical/chemical properties and the toxicological profile. Due to the fact that Ethylene glycol dimethyl ether and Diethylene glycol methyl ethyl ether have nearly the same chemical structure (especially with reference to the functional groups):

1. Ethylene glycol dimethyl ether: H3C-O-CH2-CH2-O-CH3

2. Diethylene glycol methyl ethyl ether: H3C-O-CH2-CH2 -O -CH2-CH2-O-CH2-CH3

the same mode of interaction with living cells and tissue is expected. Therefore, a read across from Ethylene glycol dimethyl ether to data obtained with Diethylene glycol methyl ethyl ether is scientifically justified.

Diethylene glycol methyl ethyl ether did not show skin sensitizing properties in the LLNA study according to the current OECD guidelines. Allergic skin reactions or case reports of acute contact dermatitis to Ethylene glycol dimethyl ether have not been described in the literature. Therefore, Ethylene glycol dimethyl ether does not have to be classified as a skin sensitizer.

A classification concerning respiratory sensitizing properties is not warranted as the classification criteria according to EU regulation 1272/2008 and 67/548 are not met.