Draize (5) Scoresii Animal Time after 1 day 4 days 7 instillation 2 days 3 days days opacity opacity opacity opacity opacity CORNEA: area area area area area 1 2 3 2 3 2 3 2 3 1 1 2 2 2 2 2 2 2 2 2 0 0 3* 2 2 2 2 IRIS 1 1 1 1 1 0 2 2 1 1 1 0 3* 2 2 ra cb dc ra dc ra dc ra cb dc ra dc CONJUNCTIVA 1 3 2 3 2 1 1 2 1 0 2 0 0 1 0 0 2 2 1 2 2 1 2 2 0 2 2 0 2 1 0 0 3* 2 2 3 2 0 2 redness chemosis discharge * terminated 2 days instillation due to a b c due to severity of iridal response Skin Sensitisation (7) Result: sensitiser Species/strain: Albino guinea-pigs Number of animals: 20 test, 10 control (Alpk: Dunkin-Hartley) Induction: Injections of 0.05 - 0.1 mL FCA plus corn oil (1:1); 1% (w/v) notified chemical in corn oil; 1% (w/v) notified chemical in FCA plus corn oil (1:1). Topical induction at day 8: 75% (w/v) notified chemical in corn oil Results: Challenge 24 hrs Concentration test control test control 3% 1/20 0/10 1/20 0/10 10% 5/20* 0/10 5/20* 1/10 All positive responses were scattered mild redness * only 2 animals exhibited a positive response at both 24 and 48 so that 8 animals in all were sensitised - a rate of 30% Test Method: directive 84/449/EEC (2) Test B1
Draize (5) Scoresii Animal 1 day Time after instillation 2 days 3 days 4 days 7 days CORNEA: opacity area opacity area opacity area opacity area opacity area 1 2 3 2 3 2 3 2 3 1 1 2 2 2 2 2 2 2 2 2 0 0 3* 2 2 2 2 IRIS 1 1 1 1 1 0 2 2 1 1 1 0 3* 2 2 CONJUNCTIVA ra cb dc ra dc ra dc ra cb dc ra dc 1 3 2 3 2 1 1 2 1 0 2 0 0 1 0 0 2 2 1 2 2 1 2 2 0 2 2 0 2 1 0 0 3* 2 2 3 2 0 2 a redness b chemosis c discharge * terminated 2 days instillation due to due to severity of iridal response Skin Sensitisation (7) Result: sensitiser Species/strain: Albino guinea-pigs Number of animals: 20 test, 10 control (Alpk: Dunkin-Hartley) Induction: Injections of 0.05 - 0.1 mL FCA plus corn oil (1:1); 1% (w/v) notified chemical in corn oil; 1% (w/v) notified chemical in FCA plus corn oil (1:1). Topical induction at day 8: 75% (w/v) notified chemical in corn oil Results: Challenge Concentration 24 hrs test control test control 3% 1/20 0/10 1/20 0/10 10% 5/20* 0/10 5/20* 1/10 All positive responses were scattered mild redness * only 2 animals exhibited a positive response at both 24 and 48 so that 8 animals in all were sensitised - a rate of 30% Test Method: directive 84/449/EEC (2) Test B1
NA233FR.docx