Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The sensitising potential of DEA was investigated in a Maximisation test according to OECD TG 406 and EEC Directive 84/449 under GLP conditions in 40 female Himalayan Guinea pigs. Based on the reactions of a pre-test, a concentration of 5% was selected for intradermal injection, of 75% for epidermal induction and of 25% for epidermal challenge in the main study. The sensitivity of the test animals was confirmed at regular intervals using formaldehyde solution as positive control. No mortalities or toxic signs occurred. No positive skin reactions were evident after 1st challenge neither when treated with physiological saline nor with 25% DEA in the control group animals. In the test group 2/20 (10%) showed erythema findings at 24 h readings, declining to 1/20 (5%) at 48 h reading, when treated with 25% DEA. Thus, according to the general assessment criteria, no skin sensitising potential of the test substance was noted in the Guinea pig maximisation test (RCC, 1990).

The industrial use of DEA in water-based metalworking fluids, and the regular, even daily exposure to these fluids is regarded as a cause of occupational sensitisation to DEA. Wet work or chemical irritation by solvents or the alkaline cutting fluid itself, and possibly mechanical irritation, seem to be important cofactors contributing to sensitisation in this special occupational group. Therefore, a slightly higher incidence of skin sensitisation in cutting fluid workers is of secondary nature, due to skin conditions not attributable to DEA (Lessman, 2009).

Migrated from Short description of key information:
DEA is not a skin sensitiser in animals. A slightly higher incidence of skin sensitisation in cutting fluid workers is of secondary nature, due to skin conditions not attributable to DEA (wet skin, chronic solvent exposure).

Justification for classification or non-classification

Based on the available data, DEA does not need to be classified for skin sensitisation according to Annex I of Directive 67/548/EEC and according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.