Appendix B: Toxicological Investigations Acute toxicity oral – Notified chemical OECD TG 423 Acute Oral Toxicity Acute Toxic Class Method. – EC Directive 92/69/EEC B.1tris Acute Oral Toxicity Acute Toxic Class – Method. Species/Strain Rat/HanBrl: Wist (SPF) Vehicle Polyethylene glycol (PEG 300) Remarks - Method No significant protocol deviations. Number and Sex Dose Mortality of Animals mg/kg bw I 3 F 2000 0 II 3 M 2000 0 LD50 > 2000 mg/kg bw of Toxicity No clinical signs were evident during the course of study. Effects in Organs No macroscopic findings were observed at necropsy. The notified chemical is of low toxicity via the oral route. RCC Ltd Acute toxicity dermal – Notified chemical OECD TG 402 Acute Dermal Toxicity. EC Directive 92/69/EEC B.3 Acute Toxicity (Dermal). Species/Strain Rat/HanBrl: WIST (SPF) Vehicle Polyethylene glycol (PEG 300) Type of dressing Semi-occlusive. Remarks - Method No significant protocol deviations. Group Number and Sex Dose Mortality of Animals mg/kg bw I 5 M 2000 0 II 5 F 2000 0 LD50 > 2000 mg/kg bw Signs of Toxicity - Local No local signs of toxicity were observed during the study period. Signs of Toxicity - Systemic No systemic signs of toxicity were observed during the study period. Effects in Organs No macroscopic findings were observed at necropsy The notified chemical is of low toxicity via the dermal route. RCC Ltd (2002q)
Appendix B: Toxicological Investigations Acute toxicity – oral Notified chemical OECD TG 423 Acute Oral Toxicity – Acute Toxic Class Method. EC Directive 92/69/EEC B.1tris Acute Oral Toxicity – Acute Toxic Class Method. Species/Strain Rat/HanBrl: Wist (SPF) Vehicle Polyethylene glycol (PEG 300) Remarks - Method No significant protocol deviations. Number and Sex of Animals Dose mg/kg bw Mortality I 3 F 2000 0 II 3 M 2000 0 LD50 > 2000 mg/kg bw of Toxicity No clinical signs were evident during the course of study. Effects in Organs No macroscopic findings were observed at necropsy. The notified chemical is of low toxicity via the oral route. RCC Ltd Acute toxicity – dermal Notified chemical OECD TG 402 Acute Dermal Toxicity. EC Directive 92/69/EEC B.3 Acute Toxicity (Dermal). Species/Strain Rat/HanBrl: WIST (SPF) Vehicle Polyethylene glycol (PEG 300) Type of dressing Semi-occlusive. Remarks - Method No significant protocol deviations. Group Number and Sex of Animals Dose mg/kg bw Mortality I 5 M 2000 0 II 5 F 2000 0 LD50 > 2000 mg/kg bw Signs of Toxicity - Local No local signs of toxicity were observed during the study period. Signs of Toxicity - Systemic No systemic signs of toxicity were observed during the study period. Effects in Organs No macroscopic findings were observed at necropsy The notified chemical is of low toxicity via the dermal route. RCC Ltd (2002q)