LD50 >2000 mg/kg bw Signs of Toxicity - Local No skin alterations at the application site were observed Signs of Toxicity - Systemic No systemic clinical signs of toxicity were observed. No test substance related effects on the body weight of animals were observed during the observation period. A slight loss of body weight observed in two female animals during the first observation period was considered a consequence of the semi-occlusive dressing. Effects in Organs The macroscopic examination at study termination revealed no organ abnormalities. The notified chemical is of low toxicity via the dermal RCC (1993b) 7.3. Acute toxicity inhalation – No test reports were submitted. 7.4. Irritation skin – Notified chemical. OECD TG 404 Acute Dermal Irritation/Corrosion. EC Directive 92/69/EEC B.4 Toxicity (Skin Irritation). Species/Strain Rabbit/New Zealand White (SPF) Number of Animals 3 Vehicle Not used Observation Period 1, 24, 48 and 72 hours Type of Dressing Semi-occlusive. Remarks - Method No significant protocol deviations. Remarks - Results No local signs of erythema or oedema were reported. The notified chemical is non-irritating to skin. RCC 7.5. Irritation eye – Notified chemical. OECD TG 405 Eye Irritation/Corrosion. EC Directive 92/69/EEC B.5 Acute Toxicity (Eye Irritation). Species/Strain Rabbit/New Zealand White Number of Animals 3 Observation Period 7 days Remarks - Method The observation period was extended to 7 days to examine the persistence of observed reactions. Lesion Mean Maximum Maximum Maximum Value at Animal No. Value Duration of Any End of Observation Effect Period
LD50 >2000 mg/kg bw Signs of Toxicity - Local No skin alterations at the application site were observed Signs of Toxicity - Systemic No systemic clinical signs of toxicity were observed. No test substance related effects on the body weight of animals were observed during the observation period. A slight loss of body weight observed in two female animals during the first observation period was considered a consequence of the semi-occlusive dressing. Effects in Organs The macroscopic examination at study termination revealed no organ abnormalities. The notified chemical is of low toxicity via the dermal RCC (1993b) 7.3. Acute toxicity – inhalation No test reports were submitted. 7.4. Irritation – skin Notified chemical. OECD TG 404 Acute Dermal Irritation/Corrosion. EC Directive 92/69/EEC B.4 Toxicity (Skin Irritation). Species/Strain Rabbit/New Zealand White (SPF) Number of Animals 3 Vehicle Not used Observation Period 1, 24, 48 and 72 hours Type of Dressing Semi-occlusive. Remarks - Method No significant protocol deviations. Remarks - Results No local signs of erythema or oedema were reported. The notified chemical is non-irritating to skin. RCC 7.5. Irritation – eye Notified chemical. OECD TG 405 Eye Irritation/Corrosion. EC Directive 92/69/EEC B.5 Acute Toxicity (Eye Irritation). Species/Strain Rabbit/New Zealand White Number of Animals 3 Observation Period 7 days Remarks - Method The observation period was extended to 7 days to examine the persistence of observed reactions. Lesion Mean Animal No. Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period
STD1044FR.docx