9. EVALUATION OF TOXICOLOGICAL DATA 9.1 Summary of Toxicological Investigations Endpoint & Result Assessment Conclusion Rat, acute oral LD50 1 120.9 mg/kg bw Harmful Rabbit, skin irritation Slightly irritating Genotoxicity - bacterial reverse mutation Non mutagenic 9.1.1 Acute Oral Toxicity Test Substance 60% notified chemical Method OECD 401 Acute Oral Toxicity. Species/Strain Rat/Sprague-Dawkey Vehicle None. Remarks - Method GLP & QA. Results Group Number & Sex Dose Mortality of Animals mg/kg bw 1 5/sex 1 000 4/10 2 5/sex 1 130 5/10 3 5/sex 1 250 6/10 4 5/sex 1 400 7/10 5 5/sex 1 560 9/10 LD50 1 120.9 mg/kg bw Signs of Toxicity Most mortality occurred within the first 24 hours after dosing. Clinical signs included convulsions, tremors, dyspnoea, cyanosis, prostration, piloerection, apathy, passivity, distended abdomen and melena. These symptoms in some animals progressed into a coma-like state followed by death. Effects in Organs Necropsy showed that dead animals had stomach ulcers and haemorrhaging of the stomach and small intestines. Those survived animals had adhesions of the stomach to liver, spleen, small intestines and omentum. These findings were consistent and a consequence of perforated stomach ulcers and subsequent peritonitis. Remarks - Results The LD50 was found to be 721.1 and 1 234.9 mg/kg for the males and females, respectively. Conclusion The test material is harmful via the oral
9. EVALUATION OF TOXICOLOGICAL DATA 9.1 Summary of Toxicological Investigations Endpoint & Result Assessment Conclusion Rat, acute oral LD50 1 120.9 mg/kg bw Harmful Rabbit, skin irritation Slightly irritating Genotoxicity - bacterial reverse mutation Non mutagenic 9.1.1 Acute Oral Toxicity Test Substance 60% notified chemical Method OECD 401 Acute Oral Toxicity. Species/Strain Rat/Sprague-Dawkey Vehicle None. Remarks - Method GLP & QA. Results Group Number & Sex of Animals Dose mg/kg bw Mortality 1 5/sex 1 000 4/10 2 5/sex 1 130 5/10 3 5/sex 1 250 6/10 4 5/sex 1 400 7/10 5 5/sex 1 560 9/10 LD50 1 120.9 mg/kg bw Signs of Toxicity Most mortality occurred within the first 24 hours after dosing. Clinical signs included convulsions, tremors, dyspnoea, cyanosis, prostration, piloerection, apathy, passivity, distended abdomen and melena. These symptoms in some animals progressed into a coma-like state followed by death. Effects in Organs Necropsy showed that dead animals had stomach ulcers and haemorrhaging of the stomach and small intestines. Those survived animals had adhesions of the stomach to liver, spleen, small intestines and omentum. These findings were consistent and a consequence of perforated stomach ulcers and subsequent peritonitis. Remarks - Results The LD50 was found to be 721.1 and 1 234.9 mg/kg for the males and females, respectively. Conclusion The test material is harmful via the oral
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