OECD TG 404 Acute Dermal Irritation/Corrosion. EC Directive 84/449/EEC B.4 Acute Toxicity (Skin Irritation). Species/Strain Rabbit/New Zealand White Number of Animals Three Vehicle Distilled Observation Period 72 hours Type of Dressing Semi-occlusive Remarks Method – Lesion Mean Score* Maximum Value Maximum Maximum at Animal No. Duration of Any End of Effect Observation Period 1 2 3 0 0 0 1 24 hours 0 Erythema/Eschar 0 0 0 1 1 hour 0 Oedema *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks Results Black staining at all treated sites. Primary irritation index is 0.25. – The notified chemical is slightly irritating to skin. Safepharm Laboratories Limited, UK(1991c). 7.4. Irritation eye – Duasyn Direct Black HEF-SF VP332 (notified chemical) OECD TG 405 Acute Eye Irritation/Corrosion. EC Directive 84/449/EEC B.5 Acute Toxicity (Eye Irritation). Species/Strain Rabbit/New Zealand White Number of Animals Three Observation Period 14 days Remarks - Method Lesion Mean Score* Maximum Maximum Maximum Value at Animal No. Duration of End of Observation Any Effect Period 1 2 3 1.3 1.3 1.7 2 7 days 0 Conjunctiva: redness 1.3 1.3 1.3 2 7 days 0 Conjunctiva: chemosis 0 1.3 1 3 48 hours 0 Conjunctiva: discharge Cannot evaluate -- -- -- Corneal opacity Staining precluded 1 1 hour 0 Iridial inflammation complete evaluation (one animal only) *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks Results Black staining at all treated sites precluded assessment of adverse – corneal effects throughout the study and assessment of the iridial effects in two animals at some of the observations. The staining persisted in all animals to the end of the 14-day observation period. All treated eyes showed slight to moderate conjunctival swelling and severe discharge 1 hour after treatment. Sloughing of the corneal epithelium was noted in one treated eye at the 24-hour observation. The notified chemical is irritating to the eye.
OECD TG 404 Acute Dermal Irritation/Corrosion. EC Directive 84/449/EEC B.4 Acute Toxicity (Skin Irritation). Species/Strain Rabbit/New Zealand White Number of Animals Three Vehicle Distilled Observation Period 72 hours Type of Dressing Semi-occlusive Remarks – Method Lesion Mean Score* Animal No. Maximum Value Maximum Duration of Any Effect Maximum at End of Observation Period 1 2 3 Erythema/Eschar 0 0 0 1 24 hours 0 Oedema 0 0 0 1 1 hour 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks – Results Black staining at all treated sites. Primary irritation index is 0.25. The notified chemical is slightly irritating to skin. Safepharm Laboratories Limited, UK(1991c). 7.4. Irritation – eye Duasyn Direct Black HEF-SF VP332 (notified chemical) OECD TG 405 Acute Eye Irritation/Corrosion. EC Directive 84/449/EEC B.5 Acute Toxicity (Eye Irritation). Species/Strain Rabbit/New Zealand White Number of Animals Three Observation Period 14 days Remarks - Method Lesion Mean Score* Animal No. Maximum Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 2 3 Conjunctiva: redness 1.3 1.3 1.7 2 7 days 0 Conjunctiva: chemosis 1.3 1.3 1.3 2 7 days 0 Conjunctiva: discharge 0 1.3 1 3 48 hours 0 Corneal opacity Cannot evaluate -- -- -- Iridial inflammation Staining precluded complete evaluation 1 (one animal only) 1 hour 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks – Results Black staining at all treated sites precluded assessment of adverse corneal effects throughout the study and assessment of the iridial effects in two animals at some of the observations. The staining persisted in all animals to the end of the 14-day observation period. All treated eyes showed slight to moderate conjunctival swelling and severe discharge 1 hour after treatment. Sloughing of the corneal epithelium was noted in one treated eye at the 24-hour observation. The notified chemical is irritating to the eye.
STD1009FR.docx