9.1.6 Skin Sensitisation (Arcelin, 1997) Guinea pigs, Himalayan Spotted Species/strain: 15 males for main study Number of animals: Induction procedure: Test group: Day 0 Three pairs of 0.1mL intradermal injections were given to the dorsal skin of the scapular region: FCA/saline, 5% notified chemical in water and 5% notified chemical in FCA/saline 1:1. Day 7 and 8 Test area massaged with 10% sodium lauryl sulphate in paraffin oil. Then, a 2 x 4 cm patch of filter paper was saturated with 0.3mL of 25% notified chemical in water and secured to the injection sites with an elastic plaster for 48 hours. Control group: Day 0 Three pairs of 0.1mL intradermal injections were given to the dorsal skin of the scapular region: FCA/saline, water vehicle and water vehicle in FCA/saline 1:1. Day 7 and 8 Test area massaged with 10% sodium lauryl sulphate in paraffin oil. Then, a 2 x 4 cm patch of filter paper was saturated with 0.3mL of water vehicle and secured to the injection sites with an elastic plaster for 48 hours. Challenge procedure: Day 22 Left flanks received 2 x 2cm patch of filter paper saturated with 0.2mL of 15% of notified chemical in water. Right flanks received filter paper saturated with water vehicle only. Patches were held in place with elastic plaster for 24 hours. OECD TG 406 Test method: Challenge outcome: No animal exhibited positive responses. Draize scores for erythema and oedema were zero for all animals at 24 hours and 48 hours following removal of challenge patches. The notified chemical was not sensitising to the skin of Result: guinea pigs. 9.2 Repeated Dose Toxicity (McKeon, 1997)
9.1.6 Skin Sensitisation (Arcelin, 1997) Species/strain: Guinea pigs, Himalayan Spotted Number of animals: 15 males for main study Induction procedure: Test group: Day 0 Day 7 and 8 Three pairs of 0.1mL intradermal injections were given to the dorsal skin of the scapular region: FCA/saline, 5% notified chemical in water and 5% notified chemical in FCA/saline 1:1. Test area massaged with 10% sodium lauryl sulphate in paraffin oil. Then, a 2 x 4 cm patch of filter paper was saturated with 0.3mL of 25% notified chemical in water and secured to the injection sites with an elastic plaster for 48 hours. Control group: Day 0 Day 7 and 8 Three pairs of 0.1mL intradermal injections were given to the dorsal skin of the scapular region: FCA/saline, water vehicle and water vehicle in FCA/saline 1:1. Test area massaged with 10% sodium lauryl sulphate in paraffin oil. Then, a 2 x 4 cm patch of filter paper was saturated with 0.3mL of water vehicle and secured to the injection sites with an elastic plaster for 48 hours. Challenge procedure: Day 22 Left flanks received 2 x 2cm patch of filter paper saturated with 0.2mL of 15% of notified chemical in water. Right flanks received filter paper saturated with water vehicle only. Patches were held in place with elastic plaster for 24 hours. Test method: OECD TG 406 Challenge outcome: No animal exhibited positive responses. Draize scores for erythema and oedema were zero for all animals at 24 hours and 48 hours following removal of challenge patches. Result: The notified chemical was not sensitising to the skin of guinea pigs. 9.2 Repeated Dose Toxicity (McKeon, 1997)