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EC number: 943-548-4 | CAS number: -
The study has been performed according to OECD guideline 406 and on Annex V, Part B of Council Directive 67/548/EEC.
The test has been performed in essence according to the original protocol of Magnusson and Kligman, on 5 male and 5 female guinea pigs in the test group and 5 male guinea pigs in the control group.
The animals were housed individually in Macrolon cages (Type 3), identified by individual ear tags, kept at a constant room temperature and a 12 hours light cycle day.
The test and control group animals were tested on one flank with substance at 50 % in physiological saline and on the other flank with the vehicle only (patch 2x2 cm; approx. 0.2 g per patch; occluded administration for 24 hours). At day 28 after that the first challenge application caused reactions in 40 % of the animals of the control group, a second challenge, using a lower test article concentration and a new control group, was performed. The test and control group animals were tested on one flank with substance at 10 % in physiological saline and on the other flank with the vehicle only (patch 2x2 cm; approx. 0.2 g per patch; occluded administration for 24 hours).
After the first challenge application 80 % and 100 % of the animals of the test group and 40 % of the animals of the control showed skin reactions. After the second challenge application, using a lower test article concentration, 50 % and 70 % of the animals of the test group at 24 and 48 hours respectively were sensitised, and none of the animals of the new control group showed skin reactions after removing the dressings.
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