Males: A very slight to well raised erythema was observed from Days 2 to 4 as well as desquamation of the skin to the application area on Days 4 and Day 5. No cutaneous lesions were noted from Day 6 onwards. Signs of Toxicity - Systemic No systemic signs of toxicity were observed. Effects in Organs No macroscopic signs. The notified chemical at 20% concentration is of low toxicity via the dermal Hazleton (1988) Irritation skin – Notified chemical (purity 99%) OECD TG 404 Acute Dermal Irritation/Corrosion. Species/Strain Rabbit/New White Number of Animals 3 Vehicle Undiluted Observation Period 14 days Type of Dressing Semi-occlusive. Remarks - Method No significant protocol deviations Lesion Mean Score* Maximum Maximum Duration Maximum Value at End Animal No. Value of Any Effect of Observation Period 1 2 3 4** 0 2 4 < 14 days 0 Erythema/Eschar 2 0 1.3 3 < 7 days 0 Oedema *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. ** Based on 24 hour score only as not assessable due to necrosis at 48- and 72-hour observation. Remarks - Results One animal was noted with deep necrosis (full thickness destruction of the skin) from the 48-hour observation period and was sacrificed for ethical reasons after the 72-hour reading. Of the two surviving animals, only very slight erythema at the 1-hour observation period was noted for one animal and mild erythema and oedema as well as scaling was noted for the remaining animal, which was resolved at the end of the observation period. The notified chemical is corrosive to the skin. RCC (2005) Irritation eye – Notified chemical (20% aqueous solution) OECD TG 405 Acute Eye Irritation/Corrosion. Species/Strain Rabbit/New White Number of Animals 6 Observation Period 72 Remarks - Method Observations for conjunctiva discharge were not recorded. Lesion Mean Score* Maximum Maximum Duration Maximum at End Value of Any Effect of Observation Period 2.96 3 > 72 h 3 Conjunctiva: redness 3.79 4 > 72 h 4 Conjunctiva: chemosis 0 0 - 0 Corneal opacity
Males: A very slight to well raised erythema was observed from Days 2 to 4 as well as desquamation of the skin to the application area on Days 4 and Day 5. No cutaneous lesions were noted from Day 6 onwards. Signs of Toxicity - Systemic No systemic signs of toxicity were observed. Effects in Organs No macroscopic signs. The notified chemical at 20% concentration is of low toxicity via the dermal Hazleton (1988) Irritation – skin Notified chemical (purity 99%) OECD TG 404 Acute Dermal Irritation/Corrosion. Species/Strain Rabbit/New White Number of Animals 3 Vehicle Undiluted Observation Period 14 days 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 4** 0 2 4 < 14 days 0 Oedema 2 0 1.3 3 < 7 days 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. ** Based on 24 hour score only as not assessable due to necrosis at 48- and 72-hour observation. Remarks - Results One animal was noted with deep necrosis (full thickness destruction of the skin) from the 48-hour observation period and was sacrificed for ethical reasons after the 72-hour reading. Of the two surviving animals, only very slight erythema at the 1-hour observation period was noted for one animal and mild erythema and oedema as well as scaling was noted for the remaining animal, which was resolved at the end of the observation period. The notified chemical is corrosive to the skin. RCC (2005) Irritation – eye Notified chemical (20% aqueous solution) OECD TG 405 Acute Eye Irritation/Corrosion. Species/Strain Rabbit/New White Number of Animals 6 Observation Period 72 Remarks - Method Observations for conjunctiva discharge were not recorded. Lesion Mean Score* Maximum Value Maximum Duration of Any Effect Maximum at End of Observation Period Conjunctiva: redness 2.96 3 > 72 h 3 Conjunctiva: chemosis 3.79 4 > 72 h 4 Corneal opacity 0 0 - 0