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EC number: 413-910-1 | CAS number: 95718-78-8
The test substance was tested for skin sensitisation in a GPMT (OECD 406, GLP). Thirty guinea-pigs (15 males and 15 females) were allocated to 2 groups: a control group (5 males and 5 females) and a treated group (10 males and 10 females).
The sensitization potential of the test substance was evaluated after a 10-day induction period during which the animals were treated with the vehicle (control group) or the test substance (treated group). On day 1, in presence of Freund's adjuvant, 0.1 ml of the test substance was administered by intradermal route at a concentration of 10% in paraffin oil. On day 8, 0.5 ml of the test substance in its original form was applied by cutaneous route. After a period of 12 days without treatment, a challenge cutaneous application of 0.5 ml of the vehicle (left flank) and 0.5 ml of the test substance at the maximal non-irritant concentration of 25% in the vehicle (right flank) were prepared on a dry compress and this was then applied to all animals. The substances were held in place for 24 hours by means of an occlusive dressing. The cutaneous reactions were then evaluated at the challenge application site, 24 and 48 hours after removal of the dressing.
After the final scoring period, the animals were sacrificed and cutaneous samples were taken from the challenge application sites in all animals. Due to the absence of macroscopic cutaneous reactions, no histological examination was performed on the cutaneous samples.
A decrease in the spontaneous activity was noted in one animal of the treated group on days 4 and 5. No clinical signs were observed in the other animals of the control and treated groups.
No deaths occurred throughout the study.
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