Females, 20 test and 10 control Number of animals: OECD TG 406 Magnusson and Kligman Maximisation Test method: Method Intradermal Induction: Induction procedure: Test animals: Day 1: three pairs of intradermal injections (0.1 mL) into the dorsal skin of the scapular region: Freund’s complete adjuvant (FCA) 1:1 in distilled water; the test substance, diluted to 25% w/v in arachis oil; the test substance at 25% w/v emulsified in a 50:50 mixture of FCA and distilled water; Topical Induction: Day 7 A 48-hour semi occluded application of 0.5 mL of – neat test substance to the treated area; Control animals: Treated similarly to the test animals omitting the test substance from the intradermal injections and topical application Test and Control animals: Challenge procedure: Day 21: A 24 hour, semi occluded application of 100% w/v and 75% w/v of test substance in arachis oil, to the right and left flank of each animal, respectively, Number of Animals Exhibiting Positive Responses Following Challenge: Test animals Control animals Challenge concentration 24 hours* 48 24 48 hours* 100% **2/20 1/20 0/10 0/10 75% 0/20 0/20 0/10 0/10 * time after patch removal. ** number of animals exhibiting positive responses. Challenge concentration of 100%: very slight erythema was Challenge Outcome: noted at the challenge site of two test animals at the 24 hour observation and persisted in one animal at the 48 hour observation. Challenge concentration of 75%: no dermal reactions were No dermal reactions were noted in control animals
Number of animals: Females, 20 test and 10 control Test method: OECD TG 406 Magnusson and Kligman Maximisation Method Induction procedure: Intradermal Induction: Test animals: Day 1: three pairs of intradermal injections (0.1 mL) into the dorsal skin of the scapular region: Freund’s complete adjuvant (FCA) 1:1 in distilled water; the test substance, diluted to 25% w/v in arachis oil; the test substance at 25% w/v emulsified in a 50:50 mixture of FCA and distilled water; Topical Induction: Day 7 – A 48-hour semi occluded application of 0.5 mL of neat test substance to the treated area; Control animals: Treated similarly to the test animals omitting the test substance from the intradermal injections and topical application Challenge procedure: Test and Control animals: Day 21: A 24 hour, semi occluded application of 100% w/v and 75% w/v of test substance in arachis oil, to the right and left flank of each animal, respectively, Number of Animals Exhibiting Positive Responses Following Challenge: Challenge Test animals Control animals concentration 24 hours* 48 24 48 hours* 100% **2/20 1/20 0/10 0/10 75% 0/20 0/20 0/10 0/10 * time after patch removal. ** number of animals exhibiting positive responses. Challenge Outcome: Challenge concentration of 100%: very slight erythema was noted at the challenge site of two test animals at the 24 hour observation and persisted in one animal at the 48 hour observation. Challenge concentration of 75%: no dermal reactions were No dermal reactions were noted in control animals
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