Abstract |
In order to assess the cutaneous allergenic potential of TKA 40207 the Maximization-Test was performed in 15 (10 test and 5 control) female albino guinea pigs, in accordance with OECD Guideline No. 406 and the Directive 96/54/EEC, B.6. The intradermal induction of sensitization in the test group was performed with a 5 % dilution of the test article in acetone/olive oil (l:1, v/v) and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline. The epidermal induction of sensitization was conducted under occlusion with the test article at 25 % in acetone/olive oil (1:1, v/v) one week after the intradermal induction. The animals of the control group were intradermally induced with acetone/olive oil (l:1, v/v) and FCA/physiological saline and epidermally induced with acetone/olive oil (1:1, v/v) under occlusion. Two weeks after epidermal induction the control and test animals were challenged by epidermal application of the test article at 5 % in acetone/olive oil (l:1, v/v) and acetone/olive oil (1:1, v/v) alone under occlusive dressing. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing. |