Safepharm Laboratories (1999g) Irritation eye – Mixture containing 30-70% Analogue 1 and < 70% Analogue 2 OECD TG 405 Acute Eye Irritation/Corrosion. EC Directive 92/69/EEC B.5 Toxicity (Eye Irritation). Species/Strain Rabbit/New Zealand White Number of Animals 3 Observation Period 72 hours Remarks - Method No significant protocol deviations. GLP compliant. Lesion Mean Score* Maximum Maximum Duration Maximum Value at End Animal No. Value of Any Effect of Observation Period 1 2 3 0 0 0 1 < 24 hours 0 Conjunctiva: redness 0 0 0 1 < 24 hours 0 Conjunctiva: chemosis 0 0 0 2 < 24 hours 0 Conjunctiva: discharge 0 0 0 0 0 0 Corneal opacity 0 0 0 0 0 0 Iridial inflammation *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results No corneal or iridal effects were noted during the study. Moderate conjunctival irritation was note in all treated eyes at 1 hour. All treated eyes appeared normal at the 24 hour observation. The mixture containing 30-70% Analogue 1 and < 70% Analogue 2 is slightly irritating to the eye. Safepharm Laboratories Irritation eye – Analogue 3 OECD TG 405 Acute Eye Irritation/Corrosion. EC Directive 92/69/EEC B.5 Toxicity (Eye Irritation). Species/Strain Rabbit/New Zealand White Number of Animals 3 Observation Period 72 hours Remarks - Method No significant protocol deviations. GLP compliant. Lesion Mean Score* Maximum Maximum Duration Maximum Value at End Animal No. Value of Any Effect of Observation Period 1 2 3 0 0.3 0.3 2 < 48 hours 0 Conjunctiva: redness 0 0 0 1 < 24 hours 0 Conjunctiva: chemosis 0 0 0.3 2 < 48 hours 0 Conjunctiva: discharge 0 0 0 0 0 0 Corneal opacity
Safepharm Laboratories (1999g) Irritation – eye Mixture containing 30-70% Analogue 1 and < 70% Analogue 2 OECD TG 405 Acute Eye Irritation/Corrosion. EC Directive 92/69/EEC B.5 Toxicity (Eye Irritation). Species/Strain Rabbit/New Zealand White Number of Animals 3 Observation Period 72 hours Remarks - Method No significant protocol deviations. GLP compliant. 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 0 0 1 < 24 hours 0 Conjunctiva: chemosis 0 0 0 1 < 24 hours 0 Conjunctiva: discharge 0 0 0 2 < 24 hours 0 Corneal opacity 0 0 0 0 0 0 Iridial inflammation 0 0 0 0 0 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results No corneal or iridal effects were noted during the study. Moderate conjunctival irritation was note in all treated eyes at 1 hour. All treated eyes appeared normal at the 24 hour observation. The mixture containing 30-70% Analogue 1 and < 70% Analogue 2 is slightly irritating to the eye. Safepharm Laboratories Irritation – eye Analogue 3 OECD TG 405 Acute Eye Irritation/Corrosion. EC Directive 92/69/EEC B.5 Toxicity (Eye Irritation). Species/Strain Rabbit/New Zealand White Number of Animals 3 Observation Period 72 hours Remarks - Method No significant protocol deviations. GLP compliant. 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 0.3 0.3 2 < 48 hours 0 Conjunctiva: chemosis 0 0 0 1 < 24 hours 0 Conjunctiva: discharge 0 0 0.3 2 < 48 hours 0 Corneal opacity 0 0 0 0 0 0
STD1233FR.docx