Appendix B: Toxicological Investigations toxicity oral – Notified Chemical OECD TG 423 Acute Oral Toxicity Acute Toxic Class Method. – Species/Strain Rat/Sprague Dawley Vehicle oil Remarks - Method No protocol deviation occurred during the study. Group Number and Sex Dose Mortality of Animals mg/kg bw 1 3 F 2000 0 2 3 F 2000 0 LD50 >2000 mg/kg bw Signs of Toxicity No clinical signs were observed Effects in Organs None Remarks - Results No treatment related changes were observed The notified chemical is of low toxicity via the oral route. Colas, S. (2011b) toxicity dermal – Notified Chemical OECD TG 402 Dermal Toxicity. Species/Strain Rat/ Sprague Dawley Vehicle Type of dressing Occlusive/Semi-occlusive. Remarks - Method No protocol deviation occurred during the study. Group Number and Sex Dose Mortality of Animals mg/kg bw 1 5 M, 5 F 2000 0 LD50 >2000 mg/kg bw of Toxicity - Local No cutaneous reactions were observed of Toxicity - Systemic No systemic clinical signs were observed Effects in Organs None Remarks - Results No treatment related changes were observed The notified chemical is of low toxicity via the dermal route. Colas, S. (2011a) Irritation skin – Notified Chemical OECD TG 404 Acute Dermal Irritation/Corrosion. Species/Strain Albino Rabbit/New Zealand White
Appendix B: Toxicological Investigations toxicity – oral Notified Chemical OECD TG 423 Acute Oral Toxicity – Acute Toxic Class Method. Species/Strain Rat/Sprague Dawley Vehicle oil Remarks - Method No protocol deviation occurred during the study. Group Number and Sex of Animals Dose mg/kg bw Mortality 1 3 F 2000 0 2 3 F 2000 0 LD50 >2000 mg/kg bw Signs of Toxicity No clinical signs were observed Effects in Organs None Remarks - Results No treatment related changes were observed The notified chemical is of low toxicity via the oral route. Colas, S. (2011b) toxicity – dermal Notified Chemical OECD TG 402 Dermal Toxicity. Species/Strain Rat/ Sprague Dawley Vehicle Type of dressing Occlusive/Semi-occlusive. Remarks - Method No protocol deviation occurred during the study. Group Number and Sex of Animals Dose mg/kg bw Mortality 1 5 M, 5 F 2000 0 LD50 >2000 mg/kg bw of Toxicity - Local No cutaneous reactions were observed of Toxicity - Systemic No systemic clinical signs were observed Effects in Organs None Remarks - Results No treatment related changes were observed The notified chemical is of low toxicity via the dermal route. Colas, S. (2011a) Irritation – skin Notified Chemical OECD TG 404 Acute Dermal Irritation/Corrosion. Species/Strain Albino Rabbit/New Zealand White
STD1503-FR-Final.docx