Registration Dossier

Administrative data

Description of key information

DEA 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.

In another BASF test, comparable results were reported when DEA was dermally applied for 1, 5, 15 min or 20 h under occlusive conditions. No skin irritation occurred after 1 - 15 min, while distinct irritation was noted after 20 h (BASF AG, 1966). The mean erythema and edema scores for 24, 48 and 72 hours in case of 20 h exposure were 1.78 and 1.5, respectively (note that erythema was present at 72 hours, while edema was absent at 72 hours). Additional findings at 24, 48, 72 hours and 8 days were brown / cent-sized necrosis, spotted appearance,erythema with anaemic center and potted crust formation.

In a third BASF study (BASF AG, 1956b) the maximal exposure duration was 15 minutes. Pure DEA and a 20% solution of DEA in water did not cause skin irritating effects in one animal.

A modified Draize test in New Zealand White rabbits with application to the intact and abraded skin revealed a moderate irritant effect with a score 2.6 out of 8 in all rabbits, those abraded exhibiting much greater irritation than those none abraded. There was a tendency to increased erythema and reduced edema after 72 hours (Dutertre-Catella et al., 1982).

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). Comparable results were reported in another BASF test (BASF AG, 1966).

Comparable results were observed in New Zealand White rabbits which received a single intraocular application of 0.1 g DEA into the conjunctival sac of the eye in a study comparable to OECD TG 405. Strong irritation was reported for the cornea, iris and conjunctiva, which reduced slightly over the 7 day observation period (Dutertre-Catella et al., 1982).


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

According to Annex I of Directive 67/548/EEC, 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.