Registration Dossier

Administrative data

Description of key information

The available skin and eye irritation studies with rabbits, performed according to methods similar to OECD guidelines, indicate that MDEA is irritating to eyes, but not to skin. 

Key value for chemical safety assessment

Skin irritation / corrosion

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

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation

A patch test with two rabbits treated with MDEA for 1, 5, 15 min or 20 h under occlusive conditions is available (similar to OECD 404, non-GLP). Application of undiluted MDEA to rabbit skin did not produce reactions after periods of 1 to 15 minutes but wide spanning reddening of the whole dorsal skin area and at the end of the observation period scale formation were reported in one animal after 20 hours contact with the substance (BASF AG, 1969). The mean erythema and edema scores after 20 hours contact for 24, 48 and 72 hours were 2.5 and 1.3, respectively. It should be noted that 20 hours exposure is relatively long compared to the prescribed 4 hours in the guideline. Furthermore, the observation period was only 8 days.

In another skin irritation study (Ballantyne and Leung, 1996b), also similar to OECD 404, erythema and edema mean scores (24, 48 and 72 hours) of 0.2 were observed after occlusive application for 4 hours. The effects were fully reversible within 72 hours.

Eye irritation

A study with 2 rabbits treated with MDEA is available for assessment (similar to OECD 405, non-GLP). A volume of 50 µl was instilled in the rabbit’s eyes and the animals were observed up to 8 days afterwards. Observations at 24, 48 and 72 h revealed redness, swelling and clouding of the cornea as well as conjunctival bleeding. The symptoms had disappeared after 8 days. Mean irritation scores over 24, 48, and 72 hours were 1 for opacity, 0 for iritis, 1.7 for erythema and 0.7 for chemosis (BASF AG, 1969).

 


Effects on eye irritation: irritating

Justification for classification or non-classification

Despite the effects observed in the patch test after 20 hours contact, the substance is not classified for skin irritation since the exposure of 20 hours is too long according to the guideline (4 hours required). In a study with the prescribed exposure duration, 4 hours, MDEA was not irritating to the skin.

Regarding eye irritation, according to Annex I of Directive 67/548/EEC, the substance is classified as Xi; R36 (irritating to eyes). According to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, the classification is H319, Cat. 2.