Skin Sensitisation in Humans, the Analogue Chemical (Boisits et al, 1993) 105 individuals, predominantly female, aged 21-60 years Study Group 100% analogue chemical Test Substance Test chemical was applied under occlusive dressing to the Induction procedure: infrascapular region of the back for 24 hours, on Mondays, Wednesdays and Fridays for 6 applications. Due to skin reactions, the remaining 2 applications were made under semi-occlusive patches. Treated sites were evaluated before reapplication of test chemical. Not conducted Challenge procedure: Repeated Insult Patch Test in Humans Test method: Due to intensity of skin reactions produced during induction, Challenge outcome: the challenge phase of the study was not conducted. 19 individuals experienced intense reactions either during Comment: the course or on completion of the induction phase of the study. 16 of these were considered to be sensitisation reactions. Subjects with severe reactions needed medical treatment to help relieve symptoms, taking up to 6 weeks in the 3 most severe cases. The test chemical was sensitising to the skin of humans. Result: Skin Sensitisation in Guineapigs, using Finished Oil containing 16% Analogue Chemical (Morris, 1994b) Guineapig / Hartley Species/strain: 10 male and 10 female test animals and 5 male and 5 female Number of animals: control animals. Induction procedure: days, 0, 7 and 14 0.3 mL of 100% finished oil (containing 16% analogue chemical), applied to intact skin, occlusive dressing for 6 hours. Control animals received Spectrum Mineral Oil Light. Challenge procedure: day 28 Test and control animals were treated with 0.3 mL of 100% test chemical (16% analogue chemical), to intact skin of a previously untreated site, under occlusive dressing for 6 hours.
Skin Sensitisation in Humans, the Analogue Chemical (Boisits et al, 1993) Study Group 105 individuals, predominantly female, aged 21-60 years Test Substance 100% analogue chemical Induction procedure: Test chemical was applied under occlusive dressing to the infrascapular region of the back for 24 hours, on Mondays, Wednesdays and Fridays for 6 applications. Due to skin reactions, the remaining 2 applications were made under semi-occlusive patches. Treated sites were evaluated before reapplication of test chemical. Challenge procedure: Not conducted Test method: Repeated Insult Patch Test in Humans Challenge outcome: Due to intensity of skin reactions produced during induction, the challenge phase of the study was not conducted. Comment: 19 individuals experienced intense reactions either during the course or on completion of the induction phase of the study. 16 of these were considered to be sensitisation reactions. Subjects with severe reactions needed medical treatment to help relieve symptoms, taking up to 6 weeks in the 3 most severe cases. Result: The test chemical was sensitising to the skin of humans. Skin Sensitisation in Guineapigs, using Finished Oil containing 16% Analogue Chemical (Morris, 1994b) Species/strain: Guineapig / Hartley Number of animals: 10 male and 10 female test animals and 5 male and 5 female control animals. Induction procedure: days, 0, 7 and 14 0.3 mL of 100% finished oil (containing 16% analogue chemical), applied to intact skin, occlusive dressing for 6 hours. Control animals received Spectrum Mineral Oil Light. Challenge procedure: day 28 Test and control animals were treated with 0.3 mL of 100% test chemical (16% analogue chemical), to intact skin of a previously untreated site, under occlusive dressing for 6 hours.
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