of 3 male rabbits. Test sites were observed for evidence of primary irritation at 1, 24, 48 and 72 hours post patch removal. Lesion Mean Score* Maximum Maximum Maximum Value at End Animal No. Value Duration of Any of Observation Period Effect 1 2 3 2 2 1.7 2 15 days 1 Erythema/Eschar ≥ 0 0 0 0 0 0 Oedema * Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results Very slight to well-defined erythema was evident at the treated site of all animals from 1 hour post application and sustained for the entire study period. Loss of elasticity was noted in one animal during the 48 hour observations but had subsided by day 15. Exfoliation was noted in all three animals during the second week of observations. There were no signs of toxicity in any of the test animals during the study. The notified chemical was irritating to rabbit skin. Huntingdon Life Sciences (2010a) Irritation eye – Notified chemical OECD TG 405 Acute Eye Irritation/Corrosion. EC Directive 2004/73/EC B.5 Acute Toxicity (Eye Irritation). Species/Strain Rabbit/New Zealand White Number of Animals 3F Observation Period 15 days Remarks - Method No significant protocol deviations. The purity of the test substance was recorded as 99.5%. A single application of 0.1 mL of the test material to the non-irrigated eye of three female rabbits. Lesion Mean Score* Maximum Maximum Duration Maximum Value at End Animal No. Value of Any Effect of Observation Period 1 2 3 1 0.7 1.3 2 < 15 days 0 Conjunctiva: redness 0 0 0.7 1 < 72 hours 0 Conjunctiva: chemosis 0 0 0 2 < 24 hours 0 Conjunctiva: discharge 1 0.7 1 1 < 15 days 0 Corneal opacity 0.3 0 0 1 < 48 hours 0 Iridial inflammation * Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results Installation of the notified chemical gave rise to a moderate initial pain response in the test animals. Crimson red conjunctival appearance was apparent in all three animals during the first 48 hours post installation, persisting in two animals at the 72 hour observations and in one animal on day 8. Slight to moderate
of 3 male rabbits. Test sites were observed for evidence of primary irritation at 1, 24, 48 and 72 hours post patch removal. Lesion Mean Score* Animal No. Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 2 3 Erythema/Eschar 2 2 1.7 2 ≥ 15 days 1 Oedema 0 0 0 0 0 0 * Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results Very slight to well-defined erythema was evident at the treated site of all animals from 1 hour post application and sustained for the entire study period. Loss of elasticity was noted in one animal during the 48 hour observations but had subsided by day 15. Exfoliation was noted in all three animals during the second week of observations. There were no signs of toxicity in any of the test animals during the study. The notified chemical was irritating to rabbit skin. Huntingdon Life Sciences (2010a) Irritation – eye Notified chemical OECD TG 405 Acute Eye Irritation/Corrosion. EC Directive 2004/73/EC B.5 Acute Toxicity (Eye Irritation). Species/Strain Rabbit/New Zealand White Number of Animals 3F Observation Period 15 days Remarks - Method No significant protocol deviations. The purity of the test substance was recorded as 99.5%. A single application of 0.1 mL of the test material to the non-irrigated eye of three female rabbits. Lesion Mean Score* Animal No. Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 2 3 Conjunctiva: redness 1 0.7 1.3 2 < 15 days 0 Conjunctiva: chemosis 0 0 0.7 1 < 72 hours 0 Conjunctiva: discharge 0 0 0 2 < 24 hours 0 Corneal opacity 1 0.7 1 1 < 15 days 0 Iridial inflammation 0.3 0 0 1 < 48 hours 0 * Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results Installation of the notified chemical gave rise to a moderate initial pain response in the test animals. Crimson red conjunctival appearance was apparent in all three animals during the first 48 hours post installation, persisting in two animals at the 72 hour observations and in one animal on day 8. Slight to moderate