Appendix A: Toxicological Investigations A.1. Acute toxicity oral – Analogue 3 OECD TG 401 Acute Oral Toxicity Limit Test. – Species/Strain Rat/Sprague-Dawley Vehicle Water Remarks - Method Test substance administered as a 10% (w/v) suspension. Group Number and Sex Dose Mortality of Animals mg/kg bw 1 5 M, 5 F 2000 0/10 LD50 > 2000 mg/kg bw Signs of Toxicity None observed. Effects in Organs None observed. Remarks - Results All animals gained the expected amount of body weight. One male (1/5) regurgitated the test substance immediately after exposure. No other clinical signs observed. The notified chemical is of low toxicity via the oral route. Pharmakon (1995) A.2. Irritation skin – Analogue 3(100%) OECD TG 404 Acute Dermal Irritation/Corrosion. Species/Strain Rabbit/New Zealand White Number of Animals 3 Male Vehicle None. Observation Period 72 hours Type of Dressing Semi-occlusive. Remarks - Method GLP compliant. Test substance was melted in a sheet and applied as a square of 2.5 cm x 2.5 cm (approximately 2 g). Lesion Mean Score* Maximum Maximum Maximum Value at End Animal No. Value Duration of Any of Observation Period Effect 1 2 3 0 0 0 1 < 24 hours 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 Very slight erythema was observed in 2/3 animals at the 1 hour observation. No other adverse effects were observed. The test substance is slightly irritating to the skin. Chrysalis (1997)
Appendix A: Toxicological Investigations A.1. Acute toxicity – oral Analogue 3 OECD TG 401 Acute Oral Toxicity – Limit Test. Species/Strain Rat/Sprague-Dawley Vehicle Water Remarks - Method Test substance administered as a 10% (w/v) suspension. Group Number and Sex of Animals Dose mg/kg bw Mortality 1 5 M, 5 F 2000 0/10 LD50 > 2000 mg/kg bw Signs of Toxicity None observed. Effects in Organs None observed. Remarks - Results All animals gained the expected amount of body weight. One male (1/5) regurgitated the test substance immediately after exposure. No other clinical signs observed. The notified chemical is of low toxicity via the oral route. Pharmakon (1995) A.2. Irritation – skin Analogue 3(100%) OECD TG 404 Acute Dermal Irritation/Corrosion. Species/Strain Rabbit/New Zealand White Number of Animals 3 Male Vehicle None. Observation Period 72 hours Type of Dressing Semi-occlusive. Remarks - Method GLP compliant. Test substance was melted in a sheet and applied as a square of 2.5 cm x 2.5 cm (approximately 2 g). Lesion Mean Score* Animal No. Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 2 3 Erythema/Eschar 0 0 0 1 < 24 hours 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 Very slight erythema was observed in 2/3 animals at the 1 hour observation. No other adverse effects were observed. The test substance is slightly irritating to the skin. Chrysalis (1997)