Appendix B: Toxicological Investigations Irritation skin – Notified chemical (purity not provided) OECD TG 404 Acute Dermal Irritation/Corrosion. Species/Strain Rabbit/New White Number of Animals 1 Vehicle Test substance administered as supplied Observation Period 21 days Type of Dressing Semi-occlusive. Remarks - Method Observations were made at 30 minutes, 24, 48, 72 and 96 hours and at 7, 14 and 21 days after patch removal. The animal was exposed to the test material for 4 hours Lesion Mean Score* Maximum Maximum Maximum Value at End Animal No. Value Duration of Any of Observation Period Effect 1 4 4 > 14 days 0 Erythema/Eschar 3 3 > 14 days 0 Oedema *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results Severe erythema and moderate oedema was observed that persisted to Day 7 and cleared by Day 21. Subcutaneous haemorrhage (observed at 30 minutes post-exposure), possible necrotic area (observed between 24 hours and 7 days) and scar tissue (observed between Day 14 and Day 21) was also observed. All irritation, with the exception of the scar tissue, cleared in the animal by the Day 21 observation. The notified chemical is corrosive to the skin. Hazleton (1995a) Irritation skin – Notified chemical (purity not provided) UN/DOT Regulations similar to OECD TG 404 Acute Dermal Irritation/Corrosion. Species/Strain Rabbit/New White Number of Animals 3 Vehicle Test substance administered as supplied Observation Period 7 days Type of Dressing Semi-occlusive. Remarks - Method Observations were made at 30 minutes, 24, 48, 72 and 96 hours and at Day 7 after patch removal. Animals were exposed to the test material for 3 minutes, 1 hour, and 4 hours. 3-minute exposure period Lesion Mean Score* Maximum Maximum Duration Maximum Value at End Animal No. Value of Any Effect of Observation Period
Appendix B: Toxicological Investigations Irritation – skin Notified chemical (purity not provided) OECD TG 404 Acute Dermal Irritation/Corrosion. Species/Strain Rabbit/New White Number of Animals 1 Vehicle Test substance administered as supplied Observation Period 21 days Type of Dressing Semi-occlusive. Remarks - Method Observations were made at 30 minutes, 24, 48, 72 and 96 hours and at 7, 14 and 21 days after patch removal. The animal was exposed to the test material for 4 hours Lesion Mean Score* Animal No. Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 Erythema/Eschar 4 4 > 14 days 0 Oedema 3 3 > 14 days 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results Severe erythema and moderate oedema was observed that persisted to Day 7 and cleared by Day 21. Subcutaneous haemorrhage (observed at 30 minutes post-exposure), possible necrotic area (observed between 24 hours and 7 days) and scar tissue (observed between Day 14 and Day 21) was also observed. All irritation, with the exception of the scar tissue, cleared in the animal by the Day 21 observation. The notified chemical is corrosive to the skin. Hazleton (1995a) Irritation – skin Notified chemical (purity not provided) UN/DOT Regulations similar to OECD TG 404 Acute Dermal Irritation/Corrosion. Species/Strain Rabbit/New White Number of Animals 3 Vehicle Test substance administered as supplied Observation Period 7 days Type of Dressing Semi-occlusive. Remarks - Method Observations were made at 30 minutes, 24, 48, 72 and 96 hours and at Day 7 after patch removal. Animals were exposed to the test material for 3 minutes, 1 hour, and 4 hours. 3-minute exposure period Lesion Mean Score* Animal No. Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period