Appendix B: Toxicological Investigations Acute toxicity oral – Notified chemical OECD TG 401 Acute Oral Toxicity Limit Test. – Species/Strain Rat/Sprague-Dawley CD, 5M/5F Vehicle None Remarks - Method No significant protocol deviations Remarks - Results There were no mortalities observed LD50 >2,000 mg/kg bw Signs of Toxicity None Effects in Organs None The notified chemical is of low toxicity via the oral route. Safepharm (1996c) Irritation skin – Notified chemical OECD TG 404 Acute Dermal Irritation/Corrosion. Species/Strain Rabbit/New White Number of Animals 3 Vehicle None Observation Period 14 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 2 1.3 2 2 <14 days 0 Erythema/Eschar 1.3 0.7 1.7 2 <14 days 0 Oedema *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results Very slight to well-defined erythema and very slight to slight oedema were noted at up to the day 7 observation. These effects were resolved by the day 14 observation. Crust formation preventing an accurate erythema reading was noted at a single treated site at the day 7 observation. Moderate desquamation was noted at the treated site of 2 animals at day 7 and slight desquamation was noted at the sites of all animals at the end of the observation period. The notified chemical is irritating to the skin. Safepharm (1996d) Irritation eye – Notified chemical OECD TG 405 Acute Eye Irritation/Corrosion.
Appendix B: Toxicological Investigations Acute toxicity – oral Notified chemical OECD TG 401 Acute Oral Toxicity – Limit Test. Species/Strain Rat/Sprague-Dawley CD, 5M/5F Vehicle None Remarks - Method No significant protocol deviations Remarks - Results There were no mortalities observed LD50 >2,000 mg/kg bw Signs of Toxicity None Effects in Organs None The notified chemical is of low toxicity via the oral route. Safepharm (1996c) Irritation – skin Notified chemical OECD TG 404 Acute Dermal Irritation/Corrosion. Species/Strain Rabbit/New White Number of Animals 3 Vehicle None Observation Period 14 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 2 1.3 2 2 <14 days 0 Oedema 1.3 0.7 1.7 2 <14 days 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results Very slight to well-defined erythema and very slight to slight oedema were noted at up to the day 7 observation. These effects were resolved by the day 14 observation. Crust formation preventing an accurate erythema reading was noted at a single treated site at the day 7 observation. Moderate desquamation was noted at the treated site of 2 animals at day 7 and slight desquamation was noted at the sites of all animals at the end of the observation period. The notified chemical is irritating to the skin. Safepharm (1996d) Irritation – eye Notified chemical OECD TG 405 Acute Eye Irritation/Corrosion.