1%, 5% or 10% 0/10** 0/10 0/10 0/5 0/5 0/5 * time after patch removal ** number of animals exhibiting positive response The notified chemical was not sensitising to the skin of Result: guinea pigs. 9.2 Repeated Dose Toxicity Component 1 Notified Chemical Analogue (Safepharm Laboratories, 1991) – rat/Sprague-Dawley. Species/strain: 5/sex. Number/sex of animals: Gavage (oral); vehicle: arachis oil. Method of administration: 0, 150, 400 and 1000 mg/kg/day for 28 days. Dose/Study duration: OECD TG 407 Test method: Clinical observations None. Bodyweight/Food Consumption No apparent adverse effects. All treated males exhibited reduced bilirubin which were not Clinical chemistry: and were within the historical control range; high dose males exhibited elevated calcium levels which were within the historical control range. Sporadic changes in some parameters in the low and mid dose groups. Haematology: Incidental findings unrelated to treatment. Macroscopic findings: Increased relative ovary weights in high dose females with one value Organ weights: outside the historical control range. Other sporadic changes were limited to the intermediate dose animals. Histopathology Slight centrilobular hepatocyte enlargement was observed for high dose male rats. Comment
1%, 5% or 10% 0/10** 0/10 0/10 0/5 0/5 0/5 * time after patch removal ** number of animals exhibiting positive response Result: The notified chemical was not sensitising to the skin of guinea pigs. 9.2 Repeated Dose Toxicity Component 1 – Notified Chemical Analogue (Safepharm Laboratories, 1991) Species/strain: rat/Sprague-Dawley. Number/sex of animals: 5/sex. Method of administration: Gavage (oral); vehicle: arachis oil. Dose/Study duration: 0, 150, 400 and 1000 mg/kg/day for 28 days. Test method: OECD TG 407 Clinical observations None. Bodyweight/Food Consumption No apparent adverse effects. Clinical chemistry: All treated males exhibited reduced bilirubin which were not and were within the historical control range; high dose males exhibited elevated calcium levels which were within the historical control range. Haematology: Sporadic changes in some parameters in the low and mid dose groups. Macroscopic findings: Incidental findings unrelated to treatment. Organ weights: Increased relative ovary weights in high dose females with one value outside the historical control range. Other sporadic changes were limited to the intermediate dose animals. Histopathology Slight centrilobular hepatocyte enlargement was observed for high dose male rats. Comment