Remarks The notified chemical is not an oxidising agent. It is stable under normal environmental conditions. 7. TOXICOLOGICAL INVESTIGATIONS Endpoint and Result Assessment Conclusion Rat, acute oral LD50 = 380 mg/kg bw harmful Rat, dermal LD50 > 2000 mg/kg bw low toxicity Rat, acute inhalation test not conducted Rabbit, skin irritation non-irritating Rabbit, eye irritation severely irritating Guinea pig, skin sensitisation - adjuvant test. evidence of sensitisation. Rat, oral repeat dose toxicity - 28 days. NOEL = 5 mg/kg bw/day Genotoxicity - bacterial reverse mutation non mutagenic Genotoxicity in chromosome aberration test non genotoxic – Genotoxicity in vivo test not conducted – 7.1. toxicity oral – Notified chemical. OECD TG 423 Acute Oral Toxicity Acute Toxic Class Method. – EC Directive 92/69/EEC B.1 tris Acute Oral Toxicity Acute Toxic – Class Method. Species/Strain Rat/HanIbm: WIST (SPF) Vehicle Polyethylene glycol PEG 300 (dose volume 10 mL/kg bw) Remarks - Method A stepwise procedure was used in relation to the deaths. Group Number and Sex Dose Mortality of Animals mg/kg bw I 3 female 2000 3/3 II 3 female 400 3/3 III 3 male 400 2/3 IV 3 female 250 0/3 V 3 male 250 0/3 VI 3 female 150 0/3 VII 3 male 150 1/3 LD50 380 mg/kg bw Signs of Toxicity Animals treated at 2000 mg/kg bw were found dead 90 minutes after treatment. Ventrolateral recumbency and respiratory distress preceded death. Five of six animals treated at 400 mg/kg bw died on day 2. Hunched posture and ruffled fur was seen in most treated animals, persisting up to test day 3. Effects in Organs A distended stomach with or without gas was observed in all animals died during the test. Remarks - Results Body weights of the surviving animals were within normal ranges for the age and strain. The notified chemical is harmful via the oral route. RCC Ltd, Toxicology Division (2000j) 7.2. Acute toxicity - dermal
Remarks The notified chemical is not an oxidising agent. It is stable under normal environmental conditions. 7. TOXICOLOGICAL INVESTIGATIONS Endpoint and Result Assessment Conclusion Rat, acute oral LD50 = 380 mg/kg bw harmful Rat, dermal LD50 > 2000 mg/kg bw low toxicity Rat, acute inhalation test not conducted Rabbit, skin irritation non-irritating Rabbit, eye irritation severely irritating Guinea pig, skin sensitisation - adjuvant test. evidence of sensitisation. Rat, oral repeat dose toxicity - 28 days. NOEL = 5 mg/kg bw/day Genotoxicity - bacterial reverse mutation non mutagenic Genotoxicity – in chromosome aberration test non genotoxic Genotoxicity – in vivo test not conducted 7.1. toxicity – oral Notified chemical. OECD TG 423 Acute Oral Toxicity – Acute Toxic Class Method. EC Directive 92/69/EEC B.1 tris Acute Oral Toxicity – Acute Toxic Class Method. Species/Strain Rat/HanIbm: WIST (SPF) Vehicle Polyethylene glycol PEG 300 (dose volume 10 mL/kg bw) Remarks - Method A stepwise procedure was used in relation to the deaths. Group Number and Sex of Animals Dose mg/kg bw Mortality I 3 female 2000 3/3 II 3 female 400 3/3 III 3 male 400 2/3 IV 3 female 250 0/3 V 3 male 250 0/3 VI 3 female 150 0/3 VII 3 male 150 1/3 LD50 380 mg/kg bw Signs of Toxicity Animals treated at 2000 mg/kg bw were found dead 90 minutes after treatment. Ventrolateral recumbency and respiratory distress preceded death. Five of six animals treated at 400 mg/kg bw died on day 2. Hunched posture and ruffled fur was seen in most treated animals, persisting up to test day 3. Effects in Organs A distended stomach with or without gas was observed in all animals died during the test. Remarks - Results Body weights of the surviving animals were within normal ranges for the age and strain. The notified chemical is harmful via the oral route. RCC Ltd, Toxicology Division (2000j) 7.2. Acute toxicity - dermal
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