The notified chemical is of low toxicity via the dermal route. Harlan (2013f) Irritation skin – Notified chemical OECD TG 404 Acute Dermal Irritation/Corrosion. Species/Strain Rabbit/New Zealand White (Hsdlf:NZW) Number of Animals 3 Vehicle Test substance administered as supplied. Observation Period 72 hours Type of Dressing Occlusive/Semi-occlusive. Remarks - Method No significant deviations from the OECD protocol. Lesion Mean Maximum Maximum Maximum Value at Animal No. Value Duration of Any End of Observation Effect Period 1 2 3 0 0.33 0.33 1 < 48 h 0 Erythema/Eschar 0 0 0 0 0 Oedema – * Calculated on the of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results Two of the treated sites showed very slight erythema at 1 h and 24 h observations after patch removal. The notified chemical is slightly irritating to the skin. Harlan (2013g) Irritation eye – Notified chemical OECD TG 405 Acute Eye Irritation/Corrosion. Species/Strain Rabbit/New Zealand White (Hsdlf:NZW) Number of Animals 3 Observation Period 72 hours Remarks - Method No significant deviations from the OECD protocol. Lesion Mean Maximum Maximum Maximum Value at End Animal No. Duration of Any of Observation Period Effect 1 2 3 0.33 0.33 0.33 2 < 48h 0 Conjunctiva: redness 0.33 0.33 0.33 2 < 48h 0 Conjunctiva: chemosis 0.00 0.33 0.33 2 < 48h 0 Conjunctiva: discharge 0.00 0.00 0.00 0 0 Corneal opacity – 0.00 0.00 0.00 0 0 Iridial inflammation – * Calculated on the of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results No corneal or iridial effects were noted during the study. All treated eyes appeared normal at the 48h observation. The notified chemical is slightly irritating to the eye.
The notified chemical is of low toxicity via the dermal route. Harlan (2013f) Irritation – skin Notified chemical OECD TG 404 Acute Dermal Irritation/Corrosion. Species/Strain Rabbit/New Zealand White (Hsdlf:NZW) Number of Animals 3 Vehicle Test substance administered as supplied. Observation Period 72 hours Type of Dressing Occlusive/Semi-occlusive. Remarks - Method No significant deviations from the OECD protocol. Lesion Mean Animal No. Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 2 3 Erythema/Eschar 0 0.33 0.33 1 < 48 h 0 Oedema 0 0 0 0 – 0 * Calculated on the of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results Two of the treated sites showed very slight erythema at 1 h and 24 h observations after patch removal. The notified chemical is slightly irritating to the skin. Harlan (2013g) Irritation – eye Notified chemical OECD TG 405 Acute Eye Irritation/Corrosion. Species/Strain Rabbit/New Zealand White (Hsdlf:NZW) Number of Animals 3 Observation Period 72 hours Remarks - Method No significant deviations from the OECD protocol. Lesion Mean Animal No. Maximum Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 2 3 Conjunctiva: redness 0.33 0.33 0.33 2 < 48h 0 Conjunctiva: chemosis 0.33 0.33 0.33 2 < 48h 0 Conjunctiva: discharge 0.00 0.33 0.33 2 < 48h 0 Corneal opacity 0.00 0.00 0.00 0 – 0 Iridial inflammation 0.00 0.00 0.00 0 – 0 * Calculated on the of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results No corneal or iridial effects were noted during the study. All treated eyes appeared normal at the 48h observation. The notified chemical is slightly irritating to the eye.
STD1523-FR-Final.DOCX