EC Directive 92/69/EEC B.4 Acute Toxicity (Skin Irritation). Species/Strain Rabbit/New Zealand White Number of Animals 6 Vehicle None Observation Period 72 hours Type of Dressing Semi-occlusive. Remarks - Method GLP & QA. Lesion Mean Maximum Value Maximum Duration Maximum Value at End of Any Effect of Observation Period 0.1 1 24 hours 0 Erythema/Eschar 0 1 4 0 Oedema *Calculated on the basis of the scores at 24, 48, and 72 hours for ALL animals. Remarks - Results The primary irritation index (PII) was calculated as 0.3. OLOA 371 is slightly irritating to skin. Corning Hazleton Inc (1997c). 7.12. Irritation - eye OLOA 371 OECD TG 405 Acute Eye Irritation/Corrosion. Species/Strain Rabbit/New Zealand White Number of Animals Unrinsed eye 6 Rinsed eye group: 3 Observation Period 72 hours Remarks - Method GLP & QA. Rinsed eye group Lesion Mean Score* Maximum Maximum Maximum Value at Animal No. Value Duration of Any End of Observation Effect Period 1 2 3 0.7 0.3 0.3 2 48 hours 0 Conjunctiva: redness 0 0 0 - - 0 Conjunctiva: chemosis 0 0 0 - - 0 Conjunctiva: discharge 0 0 0 - - 0 Corneal opacity 0 0 0 - - 0 Iridial inflammation *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Unrinsed eye Lesion Mean Score* Maximum Maximum Maximum Value at Value Duration of Any End of Observation Effect Period 0.6 2 48 hours 0 Conjunctiva: redness 0 - - 0 Conjunctiva: chemosis 0 - - 0 Conjunctiva: discharge 0 - - 0 Corneal opacity 0 - - 0 Iridial inflammation
EC Directive 92/69/EEC B.4 Acute Toxicity (Skin Irritation). Species/Strain Rabbit/New Zealand White Number of Animals 6 Vehicle None Observation Period 72 hours Type of Dressing Semi-occlusive. Remarks - Method GLP & QA. Lesion Mean Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period Erythema/Eschar 0.1 1 24 hours 0 Oedema 0 1 4 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for ALL animals. Remarks - Results The primary irritation index (PII) was calculated as 0.3. OLOA 371 is slightly irritating to skin. Corning Hazleton Inc (1997c). 7.12. Irritation - eye OLOA 371 OECD TG 405 Acute Eye Irritation/Corrosion. Species/Strain Rabbit/New Zealand White Number of Animals Unrinsed eye 6 Rinsed eye group: 3 Observation Period 72 hours Remarks - Method GLP & QA. Rinsed eye group Lesion Mean Score* Animal No. Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 2 3 Conjunctiva: redness 0.7 0.3 0.3 2 48 hours 0 Conjunctiva: chemosis 0 0 0 - - 0 Conjunctiva: discharge 0 0 0 - - 0 Corneal opacity 0 0 0 - - 0 Iridial inflammation 0 0 0 - - 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Unrinsed eye Lesion Mean Score* Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period Conjunctiva: redness 0.6 2 48 hours 0 Conjunctiva: chemosis 0 - - 0 Conjunctiva: discharge 0 - - 0 Corneal opacity 0 - - 0 Iridial inflammation 0 - - 0
STD1087FR.docx