7.4. Irritation skin – Notified chemical OECD TG 404 Acute Dermal Irritation/Corrosion. EC Directive 92/69/EEC B.4 Acute Toxicity (Skin Irritation). Species/Strain Rabbit/New Zealand White Number of Animals 1 male, 2 females Vehicle Moistened with aqua bidest Observation Period 72 Type of Dressing Semi-occlusive Remarks - Method No significant protocol deviations. Lesion Mean Score* Maximum Maximum Duration Maximum Value at End of Animal No. Value of Any Effect Observation Period 1 2 3 0 0 0 1 1 h 0 Erythema/Eschar 0 0 0 0 0 h 0 Oedema *Calculated on the of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results Slight erythema observed in 1 animal was reversible within 24 h post treatment. Primary irritation = 0.08 (slightly irritating). The notified chemical is slightly irritating to skin. BASF (1998c) 7.5. Irritation eye – Notified chemical 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 females Observation Period 72 hours Remarks - Method A single animal was treated initially, followed by another two animals due to the lack of severe findings in the first animal. Lesion Mean Score* Maximum Maximum Maximum Value at Animal No. Value Duration of Any End of Observation Effect Period 1 2 3 1.0 0.7 0.3 2 48 h 0 Conjunctiva: redness 0.3 0.0 0.0 1 24 h 0 Conjunctiva: chemosis 0 0 0 1 1 h 0 Conjunctiva: discharge 0 0 0 0 0 h 0 Corneal opacity 0 0 0 0 0 h 0 Iridial inflammation *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results Signs of irritation were reversible within 72 h post treatment. The notified chemical is slightly irritating to the eye.
7.4. Irritation – skin Notified chemical OECD TG 404 Acute Dermal Irritation/Corrosion. EC Directive 92/69/EEC B.4 Acute Toxicity (Skin Irritation). Species/Strain Rabbit/New Zealand White Number of Animals 1 male, 2 females Vehicle Moistened with aqua bidest Observation Period 72 Type of Dressing Semi-occlusive Remarks - Method No significant protocol deviations. Lesion Mean Score* Animal No. Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 2 3 Erythema/Eschar 0 0 0 1 1 h 0 Oedema 0 0 0 0 0 h 0 *Calculated on the of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results Slight erythema observed in 1 animal was reversible within 24 h post treatment. Primary irritation = 0.08 (slightly irritating). The notified chemical is slightly irritating to skin. BASF (1998c) 7.5. Irritation – eye Notified chemical 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 females Observation Period 72 hours Remarks - Method A single animal was treated initially, followed by another two animals due to the lack of severe findings in the first animal. 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 0.7 0.3 2 48 h 0 Conjunctiva: chemosis 0.3 0.0 0.0 1 24 h 0 Conjunctiva: discharge 0 0 0 1 1 h 0 Corneal opacity 0 0 0 0 0 h 0 Iridial inflammation 0 0 0 0 0 h 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results Signs of irritation were reversible within 72 h post treatment. The notified chemical is slightly irritating to the eye.
STD1080FR.docx