Challenge outcome: Test animals Control animals Challenge concentration 24 hours* 48 hours* 24 hours 48 hours 10% **0/20 0/20 0/10 0/10 * time after patch removal ** number of animals exhibiting positive response Magnusson and Kligman maximisation test, OECD Test method: TG 406 (Organisation for Economic Co-operation and Development, 1995-1996) the notified chemical was not sensitising to the skin Result: of guinea pigs Repeated Dose Toxicity (Allan, 1996) rat/Sprague-Dawley Species/strain: 5/sex for each dose group, additional 5/sex (control Number/sex of animals: and 1 000 mg/kg/day) satellite groups with a 4 week recovery period oral (gavage) Method of administration: animals were treated once daily for 28 consecutive Dose/Study duration:: days (vehicle: corn oil); group 1: control group 2: 15 mg/kg/day; group 3: 150 mg/kg/day; group 4: 1 000 mg/kg/day. bodyweight gains were lower than controls for Clinical observations: group 4 males; no significant behavioural changes observed. 4, and higher triglyceride levels for group 4 Clinical females; creatine phosphokinase levels were higher chemistry/Haematology than control for group 4 males and lower than control for group 4 females. higher alkaline phosphatase levels no significant changes in biochemical parameters were recorded for in recovery animals; no significant changes in 4 males at week haematological parameters in any animal. increased relative liver weights were recorded for weights: group 4 males and females, and increased relative
Challenge outcome: Challenge Test animals Control animals concentration 24 hours* 48 hours* 24 hours 48 hours 10% **0/20 0/20 0/10 0/10 * time after patch removal ** number of animals exhibiting positive response Test method: Magnusson and Kligman maximisation test, OECD TG 406 (Organisation for Economic Co-operation and Development, 1995-1996) Result: the notified chemical was not sensitising to the skin of guinea pigs Repeated Dose Toxicity (Allan, 1996) Species/strain: rat/Sprague-Dawley Number/sex of animals: 5/sex for each dose group, additional 5/sex (control and 1 000 mg/kg/day) satellite groups with a 4 week recovery period Method of administration: oral (gavage) Dose/Study duration:: animals were treated once daily for 28 consecutive days (vehicle: corn oil); group 1: control group 2: 15 mg/kg/day; group 3: 150 mg/kg/day; group 4: 1 000 mg/kg/day. Clinical observations: bodyweight gains were lower than controls for group 4 males; no significant behavioural changes observed. Clinical chemistry/Haematology higher alkaline phosphatase levels were recorded for 4 males at week 4, and higher triglyceride levels for group 4 females; creatine phosphokinase levels were higher than control for group 4 males and lower than control for group 4 females. no significant changes in biochemical parameters in recovery animals; no significant changes in haematological parameters in any animal. weights: increased relative liver weights were recorded for group 4 males and females, and increased relative