Registration Dossier

Administrative data

Description of key information

Diethanolamine (DEA) which is present at levels up to a maximum of 25% in the multiconstituent substance is a skin and a severe eye irritant in rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation

A patch test with two rabbits comparing the irritation potential of pure and technical DEA dermally applied for 1, 5, 15 min or 20 h under occlusive conditions is available. Both compounds led to slight skin irritation after 1 - 15 min, while distinct irritation was noted after 20 h (BASF AG, 1968). The mean erythema and edema scores for 24, 48 and 72 hours in case of 20 h exposure were 2 and 1.33, respectively (note that erythema was present at 72 hours, while edema was absent at 72 hours). At 72 hours, in one animal pergamentry red-yellowish necrosis was observed, while the other one showed a spotted appearance. At day 8, in both animals strong desquamation was observed.

Triethanolamine was found not irritating to rabbit skin.

Eye irritation

A study on pure and technical DEA is available for assessment. A volume of 0.1 ml was instilled in the rabbit’s eyes and the animals were observed for 8 days. Observations at 24, 48 and 72 h revealed severe signs of irritation consisting of superficial corrosion, distinct corneal opacity, conjunctival bleeding, distinct conjunctival redding, distinct oedema and conjunctival scale with no reliable difference between the pure and the technical product indicating a severe damage to ocular tissue (BASF AG, 1968).

Triethanolamine was found not irritating to rabbit eye.

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: highly irritating

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Based on the data available and the harmonised classification for diethanolamine, which is present at levels up to 25 % in the substance, the substance is classified as Xi; R38 (irritating to skin) and R41 (risk of serious damage to eyes).

According to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, the classification is H315, Cat. 2 and H318, Cat. 1.