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 White Number of Animals 3 males Vehicle None Observation Period 72 h Type of Dressing Semi-occlusive. Remarks - Method No significant protocol deviations. One animal was treated initially, and two animals were treated 14 days later. The observation period for the two animals treated later was 72 h. Remarks - Results No irritation, corrosion, staining or systemic toxicity was observed in the animals during the test period. No mortality occurred during the test period. The table of individual skin irritation scores was not provided. The notified chemical is non-irritating to the skin. NOTOX (2004c) 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 White Number of Animals 3 males Observation Period 72 h Remarks - Method No protocol deviations were reported. One animal was treated initially, and a further two animals five days later. Observations were terminated after 72 h. Lesion Mean Score* Maximum Maximum Maximum at End Animal No. Value Duration of Any of Observation Period Effect 1 2 3 0.33 1 0.33 2 48 h 0 Conjunctiva: redness 0 0 0.33 2 24 h 0 Conjunctiva: chemosis 0.33 0.33 0.33 1 24 h 0 Conjunctiva: discharge 0 0 0 0 - 0 Corneal opacity 0 0 0 1 1 h 0 Iridial inflammation *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results No evidence of corrosion, staining or systemic toxicity was observed during the test period. No mortality occurred during the test period. The notified chemical is slightlyirritating to the eye. NOTOX (2004d) Skin sensitisation mouse local lymph node assay (LLNA) –
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 White Number of Animals 3 males Vehicle None Observation Period 72 h Type of Dressing Semi-occlusive. Remarks - Method No significant protocol deviations. One animal was treated initially, and two animals were treated 14 days later. The observation period for the two animals treated later was 72 h. Remarks - Results No irritation, corrosion, staining or systemic toxicity was observed in the animals during the test period. No mortality occurred during the test period. The table of individual skin irritation scores was not provided. The notified chemical is non-irritating to the skin. NOTOX (2004c) 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 White Number of Animals 3 males Observation Period 72 h Remarks - Method No protocol deviations were reported. One animal was treated initially, and a further two animals five days later. Observations were terminated after 72 h. Lesion Mean Score* Animal No. Maximum Value Maximum Duration of Any Effect Maximum at End of Observation Period 1 2 3 Conjunctiva: redness 0.33 1 0.33 2 48 h 0 Conjunctiva: chemosis 0 0 0.33 2 24 h 0 Conjunctiva: discharge 0.33 0.33 0.33 1 24 h 0 Corneal opacity 0 0 0 0 - 0 Iridial inflammation 0 0 0 1 1 h 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results No evidence of corrosion, staining or systemic toxicity was observed during the test period. No mortality occurred during the test period. The notified chemical is slightlyirritating to the eye. NOTOX (2004d) Skin sensitisation – mouse local lymph node assay (LLNA)
STD1434FR.docx