Topical challenge: undiluted main Number of Animals Test Group: 20 Control Group: 10 Induction Induction Concentration: undiluted Signs of Irritation None challenge phase 1st challenge Topical application: undiluted 2nd challenge Topical application: not conducted Remarks Method Topical induction, elicitation, no positive control. – No skin reactions were noted at challenge sites at any observation period (day 1-30). Animal Challenge Concentration Number of Animals Showing Skin Reactions after: 1st challenge 2nd challenge 24 h 48 h 24 h 48 h 0 0 0 0 Test Group 0 0 0 0 Control was no evidence of reactions indicative of skin sensitisation to the notified chemical under the conditions of the test. Safepharm 7.7. Repeat dose toxicity Analogue. The method followed was that outlined in V, Part B, Method B7 in the EEC Directive 84/449/EEC and OECD Guidelines for Testing of Chemicals No. 407, Dose Oral Toxicity Rodent: 28-day or “Repeated – 14 day study”. – 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: - All animals were killed and examined macroscopically on day 29. Vehicle Distilled water. Remarks Method No significant protocol deviations. – Group Number and Sex Dose Mortality of Animals mg/kg bw/day I (control) 5 male, 5 female 0 (distilled water) 0 II (low dose) 5 male, 5 female 15 mg/kg/day 0 III (mid dose) 5 male, 5 female 150 mg/kg/day 0 IV (high dose) 5 male, 5 female 750 mg/kg/day 0 V (control recovery) VI (high dose recovery) Mortality and Time to Death No mortality was observed during treatment period.
Topical challenge: undiluted main Number of Animals Test Group: 20 Control Group: 10 Induction Induction Concentration: undiluted Signs of Irritation None challenge phase 1st challenge Topical application: undiluted 2nd challenge Topical application: not conducted Remarks – Method Topical induction, elicitation, no positive control. No skin reactions were noted at challenge sites at any observation period (day 1-30). Animal Challenge Concentration Number of Animals Showing Skin Reactions after: 1st challenge 2nd challenge 24 h 48 h 24 h 48 h Test Group 0 0 0 0 Control 0 0 0 0 was no evidence of reactions indicative of skin sensitisation to the notified chemical under the conditions of the test. Safepharm 7.7. Repeat dose toxicity Analogue. The method followed was that outlined in V, Part B, Method B7 in the EEC Directive 84/449/EEC and OECD Guidelines for Testing of Chemicals No. 407, “Repeated Dose Oral Toxicity – Rodent: 28-day or 14 – day study”. 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: - All animals were killed and examined macroscopically on day 29. Vehicle Distilled water. Remarks – Method No significant protocol deviations. Group Number and Sex of Animals Dose mg/kg bw/day Mortality I (control) 5 male, 5 female 0 (distilled water) 0 II (low dose) 5 male, 5 female 15 mg/kg/day 0 III (mid dose) 5 male, 5 female 150 mg/kg/day 0 IV (high dose) 5 male, 5 female 750 mg/kg/day 0 V (control recovery) VI (high dose recovery) Mortality and Time to Death No mortality was observed during treatment period.
Std1028FR.docx