Irritation skin – Notified chemical OECD TG 404 Acute Dermal Irritation/Corrosion. EC Directive 2004/73/EC B.4 Acute Toxicity (Skin Irritation). Species/Strain Rabbit/New Zealand White Number of Animals 3 males Vehicle Test substance administered as supplied Observation Period 7 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 1 1 1.3 2 < 7 days 0 Erythema/Eschar 0.3 0 0.7 1 < 72 hours 0 Oedema *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results A single 4-hour, semi-occluded application of the test material to the intact skin of the three rabbits produced very slight to well-defined erythema and very slight oedema at the 24 hour observation. Slight erythema was noted at all treated skin sites at 48 hours. One treated skin site appeared normal at the 72-hour observation and the remaining two treated skin sites appeared normal at the 7-day observation. No corrosive effects were noted. The notified chemical is slightly irritating to the skin. Safepharm Laboratories (2007e) Irritation eye – Notified chemical OECD TG 405 Acute Eye Irritation/Corrosion. EC Directive 2004/73/EC B.5 Acute Toxicity (Eye Irritation). Species/Strain Rabbit/New Zealand White Number of Animals 3 males Observation Period 72 hours Remarks - Method No significant protocol deviations Lesion Mean Maximum Maximum Duration Maximum Value at End Animal No. Value of Any Effect of Observation Period 1 2 3 0.7 0.7 1 2 < 72 hours 0 Conjunctiva: redness 0.3 0.3 0.3 1 < 48 hours 0 Conjunctiva: chemosis 0.3 0.3 0.3 1 < 48 hours 0 Conjunctiva: discharge 0 0 0 0 0 0 Corneal opacity 0 0.3 0.3 < 48 hours 0 Iridial inflammation *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results A single application of the test material to the non-irrigated eye of three rabbits produced iridial inflammation and moderate conjunctival
Irritation – skin Notified chemical OECD TG 404 Acute Dermal Irritation/Corrosion. EC Directive 2004/73/EC B.4 Acute Toxicity (Skin Irritation). Species/Strain Rabbit/New Zealand White Number of Animals 3 males Vehicle Test substance administered as supplied Observation Period 7 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 1 1 1.3 2 < 7 days 0 Oedema 0.3 0 0.7 1 < 72 hours 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results A single 4-hour, semi-occluded application of the test material to the intact skin of the three rabbits produced very slight to well-defined erythema and very slight oedema at the 24 hour observation. Slight erythema was noted at all treated skin sites at 48 hours. One treated skin site appeared normal at the 72-hour observation and the remaining two treated skin sites appeared normal at the 7-day observation. No corrosive effects were noted. The notified chemical is slightly irritating to the skin. Safepharm Laboratories (2007e) Irritation – eye Notified chemical OECD TG 405 Acute Eye Irritation/Corrosion. EC Directive 2004/73/EC B.5 Acute Toxicity (Eye Irritation). Species/Strain Rabbit/New Zealand White Number of Animals 3 males Observation Period 72 hours Remarks - Method No significant protocol deviations Lesion Mean Animal No. Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 2 3 Conjunctiva: redness 0.7 0.7 1 2 < 72 hours 0 Conjunctiva: chemosis 0.3 0.3 0.3 1 < 48 hours 0 Conjunctiva: discharge 0.3 0.3 0.3 1 < 48 hours 0 Corneal opacity 0 0 0 0 0 0 Iridial inflammation 0 0.3 0.3 < 48 hours 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results A single application of the test material to the non-irrigated eye of three rabbits produced iridial inflammation and moderate conjunctival