Registration Dossier

Administrative data

Description of key information

Irritation:
- skin: corrosive
- eye: corrosive

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation:

In a primary skin irritation study, according to OECD guideline 404 with undiluted DEAE a 3 min occlusive exposure, as well as semi-occlusive exposure caused only slight erythema. It was reversible by the end of the experiment. Some scaling was observed on day 7. After a 1 hr and 4 hr occlusive and semi-occlusive exposure severe erythema, eschar formation and necrosis were observed. Very slight to slight edema was also observed. By day 7 after application the findings were not reversed. Necrosis was confirmed histologically (BASF 1982; Val 2). In a second skin irritation study a 3 min exposure caused similar slight erythema and in one animal slight edema was observed. After 8 days slight scaling remained as a residual sign and 1 animal showed a lentil-sized skin-deep necrosis. After 1 h exposure distinct erythema and edema were noted. During the 8 day observation period the symptoms intensified and after 8 days necrosis, as signs of irreversible skin irritation, were observed (BASF 1978; Val 2). Corrosive effects to skin were also found in four other valid studies (BASF 1968; BASF 1980, Union Carbide 1986/1990; Elf Atochem 1972; all Val. 2).

 

Eye irritation:

In a primary eye irritation study in rabbits, 50 µL of the test substance were applied to the conjunctival sac of one eye in 2 animals and caused corrosive effects. Severe findings like hemorrhage into the conjunctivae and purulent exsudates were observed throughout the study period, which were accompanied by conjunctival redness of grade 2 and chemosis of grades 2 to 3. Starting shortly after application corneal opacity was observed which persisted over the study period of 8 days and led to irreversible damage to corneal tissue (BASF 1968; Val 2).

In a further eye irritation study, initially, the conjunctivae were severely inflamed with minimal swelling and with patches of necrosis. Eyes were completely necrotic after 24 hours. No signs of recovery were seen after 7 days (Pennwalt 1977; Val. 2). A third study validated this severe corneal injury (with vascularization and irregular shape), iritis and severe conjunctival irritation, including necrosis (Union Carbide 1986; Val. 2).


Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

2-Diethylaminoethanol was corrosive to the skin and eyes of rabbits. Since its pH value was measured to be 11.5 (100 g/l) at 20 °C, these corrosive effects are not surprising.

EU classification according to Annex I of Directive 67/548/EEC: C; R34

EU classification according to EC/1272/2008 (CLP):Cat 1