Treatment Maximum Number of animals with Days to normal average cornea involvement 3 mg test substance, 16.7 2 of 3 2 in 3 days, 1 in 4 unrinsed eyes days 3 mg test substance, 5.3 0 of 3 3 in 2 days rinsed eyes 0.1 mL 10% test 28.0 3 of 3 2 in 4 days, 1 in 21 substance days The test substance was judged to be a slight to moderate eye irritant in rabbits. 9.1.6 Skin Sensitisation (Saitama Institute, 2000) guinea pig/Dunkin-Hartley. Species/strain: 10 test; 5 controls. Number of animals: Induction procedure: days 1 -14 test group: Twice weekly occluded applications of 10% BA-20 were applied for 24 hours twice per week for 2 weeks. An intradermal injection of 0.1 mL of Freund’s Complete Adjuvant was administered separately at 2 sites in the patched area of skin once before the 3rd treatment. control group: The control group received 50% ethanol in water under the same conditions as the test group. Challenge procedure: day 21 The flank was shaved and solutions (1, 5 and 10%) of the test substance applied. Sites were scored at 24, 48 and 72 hours. Cumulative enhancement protocol (Tsuchiya 1985) Test method: et. al, Challenge outcome: Test animals Control animals Challenge concentration 24 48 72 24 48 hours 72 hours* hours*
Treatment Maximum average Number of animals with cornea involvement Days to normal 3 mg test substance, unrinsed eyes 16.7 2 of 3 2 in 3 days, 1 in 4 days 3 mg test substance, rinsed eyes 5.3 0 of 3 3 in 2 days 0.1 mL 10% test substance 28.0 3 of 3 2 in 4 days, 1 in 21 days The test substance was judged to be a slight to moderate eye irritant in rabbits. 9.1.6 Skin Sensitisation (Saitama Institute, 2000) Species/strain: guinea pig/Dunkin-Hartley. Number of animals: 10 test; 5 controls. Induction procedure: days 1 -14 test group: Twice weekly occluded applications of 10% BA-20 were applied for 24 hours twice per week for 2 weeks. An intradermal injection of 0.1 mL of Freund’s Complete Adjuvant was administered separately at 2 sites in the patched area of skin once before the 3rd treatment. control group: The control group received 50% ethanol in water under the same conditions as the test group. Challenge procedure: day 21 The flank was shaved and solutions (1, 5 and 10%) of the test substance applied. Sites were scored at 24, 48 and 72 hours. Test method: Cumulative enhancement protocol (Tsuchiya et. al, 1985) Challenge outcome: Challenge Test animals Control animals concentration 24 48 hours* 72 hours* 24 48 hours 72
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