Irritation skin – 40-55% notified chemical in glycerin OECD TG 404 Acute Dermal Irritation/Corrosion. EC Directive 2004/73/EC B.4 Acute Toxicity (Skin Irritation). Species/Strain Rabbit/New Number of Animals 3 F Vehicle None Observation Period 72 Type of Dressing Semi-occlusive. Remarks - Method No deviations from the protocol. Lesion Mean Score* Maximum Maximum Duration Maximum Value at End Animal No. of Any Effect of Observation Period 1 2 3 0 0 0 0 - 0 Erythema/Eschar 0 0 0 0 - 0 Oedema *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results No skin reactions were observed in all treated animals. The test substance is non-irritating to the skin. Frey-Tox (2007c) Irritation eye – 40-55% notified chemical in glycerin OECD TG 405 Acute Eye Irritation/Corrosion. EC Directive 2004/73/EC B.5 Acute Toxicity (Eye Irritation). Species/Strain Rabbit/New White Number of Animals 3 F Observation Period 72 hours Remarks - Method No deviations from the protocol. Conjunctiva: discharge was not recorded. 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 1 < 48 h 0 Conjunctiva: redness 0 0 0 0 - 0 Conjunctiva: chemosis 0 0 0 0 - 0 Corneal opacity 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 One hour after the application of the test substance all tested animals showed some hyperaemic conjunctival blood vessels. 24 h after the application of the test substance some hyperaemic conjunctival blood vessels were still observed at two animals, whereas one animal did not show any ocular reactions. 48 h and 72 h after the application of the test substance all animals were free of any signs of eye irritation.
Irritation – skin 40-55% notified chemical in glycerin OECD TG 404 Acute Dermal Irritation/Corrosion. EC Directive 2004/73/EC B.4 Acute Toxicity (Skin Irritation). Species/Strain Rabbit/New Number of Animals 3 F Vehicle None Observation Period 72 Type of Dressing Semi-occlusive. Remarks - Method No deviations from the protocol. Lesion Mean Score* Animal No. Maximum Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 2 3 Erythema/Eschar 0 0 0 0 - 0 Oedema 0 0 0 0 - 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results No skin reactions were observed in all treated animals. The test substance is non-irritating to the skin. Frey-Tox (2007c) Irritation – eye 40-55% notified chemical in glycerin OECD TG 405 Acute Eye Irritation/Corrosion. EC Directive 2004/73/EC B.5 Acute Toxicity (Eye Irritation). Species/Strain Rabbit/New White Number of Animals 3 F Observation Period 72 hours Remarks - Method No deviations from the protocol. Conjunctiva: discharge was not recorded. 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 1 < 48 h 0 Conjunctiva: chemosis 0 0 0 0 - 0 Corneal opacity 0 0 0 0 - 0 Iridial inflammation 0 0 0 0 - 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results One hour after the application of the test substance all tested animals showed some hyperaemic conjunctival blood vessels. 24 h after the application of the test substance some hyperaemic conjunctival blood vessels were still observed at two animals, whereas one animal did not show any ocular reactions. 48 h and 72 h after the application of the test substance all animals were free of any signs of eye irritation.
STD1340FR1.docx