Registration Dossier

Administrative data

Description of key information

Skin irritation: 2 studies (1 key study/1 supporting study) available: moderately/not irritating
Eye irritation: 2 studies (1 key study/1 supporting study) available: not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

There is one reliable study available on the skin irritancy potential. Ethylene glycol dimethyl ether was tested for its skin irritant properties in 6 Himalayan rabbits. The study was performed according to OECD Guideline 404. Deviations were the absence of the recovery period of 14 days and a prolonged exposure period (24 hours). These conditions make the study design more rigid compared to the regarding OECD Guideline. Effects skin (erythema grades up to 4 and edema scores up to 2) were observed in all animals 48 hour after application. These signs were not reversible within the 72 hours observation period. In a further supporting study with restricted reporting Ethylene glycol dimethyl ether did not cause any irritation to the skin.

There is one study available on the eye irritancy potential. Ethylene glycol dimethyl ether was tested for its eye irritant properties in 6 NewZealandWhite rabbits. The study was performed according to OECD Guideline 405. The only deviation was the absence of the recovery period of 14 days. Effects on conjunctivae (redness and swelling) were observed in all animals one hour after application. These signs decreased significantly within 72 hours and full reversibility is assumed occur after 14 days recovery. This observation is confirmed by the results of a supporting study.


Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

With reference the reported scores and the absence reversibility of the observed effects to the skin Ethylene glycol dimethyl ether has to be classified as irritant to the skin (R38 - irritant to skin; H315 - causes skin irritation, skin irritant category 2) according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

With reference the reported scores and the reversibility of the observed effects on the rabbit’s eye Ethylene glycol dimethyl ether does not have to be classified as irritant to the eyes according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).