Ciba-Geigy Ltd (1992r) Skin sensitisation Notified chemical OECD TG 406 Skin Sensitisation Magnuson and Kligman Method. – EC Directive 84/449/EC B.6 Skin Sensitisation - Magnuson and Kligman Method. Species/Strain Guinea pig/Pirbright White Strain (Tif: DHP) preliminary study Maximum Non-irritating Concentration: intradermal: 5% topical: 50% (maximum dose tested) main study Number of Animals Test Group: 20 Control Group: 10 induction phase Induction Concentration: intradermal: 5% topical: 50% in vaseline of Irritation No test substance related irritation was observed. challenge phase 1st challenge topical: 50% in vaseline 2nd challenge Not performed. Remarks - Method As no skin irritation was observed in the pretest the epidermal application site was pretreated with 10% sodium lauryl sulphate 24 hours prior to epidermal induction. Animal Challenge Concentration Number of Animals Showing Skin Reactions after: 1st challenge 2nd challenge 24 h 48 h 24 h 48 h 50% 0/20 0/20 - - Test 50% 0/10 0/10 - - Control Group Remarks - Results Under the experimental conditions employed none of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings. was no evidence of reactions indicative of skin sensitisation to the notified chemical under the conditions of the test. Ciba-Geigy Ltd (1993b) Repeat dose toxicity Notified chemical In-house method, similar to: OECD TG 407 Repeated Dose 28-day Oral Toxicity Study in Rodents. EC Directive 96/54/EC B.7 Repeated Dose (28 Days) Toxicity (Oral). Species/Strain Rat/Sprague-Dawley Route of Administration Oral gavage – Exposure Information Total exposure days: 28 days; Dose regimen: 7 days per week; Post-exposure observation period: 0 days Vehicle Peanut oil
Ciba-Geigy Ltd (1992r) Skin sensitisation Notified chemical OECD TG 406 Skin Sensitisation – Magnuson and Kligman Method. EC Directive 84/449/EC B.6 Skin Sensitisation - Magnuson and Kligman Method. Species/Strain Guinea pig/Pirbright White Strain (Tif: DHP) preliminary study Maximum Non-irritating Concentration: intradermal: 5% topical: 50% (maximum dose tested) main study Number of Animals Test Group: 20 Control Group: 10 induction phase Induction Concentration: intradermal: 5% topical: 50% in vaseline of Irritation No test substance related irritation was observed. challenge phase 1st challenge topical: 50% in vaseline 2nd challenge Not performed. Remarks - Method As no skin irritation was observed in the pretest the epidermal application site was pretreated with 10% sodium lauryl sulphate 24 hours prior to epidermal induction. Animal Challenge Concentration Number of Animals Showing Skin Reactions after: 1st challenge 2nd challenge 24 h 48 h 24 h 48 h Test 50% 0/20 0/20 - - Control Group 50% 0/10 0/10 - - Remarks - Results Under the experimental conditions employed none of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings. was no evidence of reactions indicative of skin sensitisation to the notified chemical under the conditions of the test. Ciba-Geigy Ltd (1993b) Repeat dose toxicity Notified chemical In-house method, similar to: OECD TG 407 Repeated Dose 28-day Oral Toxicity Study in Rodents. EC Directive 96/54/EC B.7 Repeated Dose (28 Days) Toxicity (Oral). Species/Strain Rat/Sprague-Dawley Route of Administration Oral – gavage Exposure Information Total exposure days: 28 days; Dose regimen: 7 days per week; Post-exposure observation period: 0 days Vehicle Peanut oil