EC Council Regulation No 440/2008 A.9 Flash Point. Remarks Closed cup equilibrium method. Harlan (2011g) > 400 °C Autoignition Temperature EC Council Regulation No 440/2008 A.15 Auto-Ignition Temperature (Liquids and Gases). Harlan (2011h) Appendix B: Toxicological Investigations Acute toxicity oral – Notified chemical OECD TG 420 Acute Oral Toxicity Fixed Dose Procedure. – EC Directive 92/69/EEC, B.1 Species/Strain Rat/Sprague-Dawley Rj:SD (IOPS Han) Vehicle 0.5% suspension of methylcellulose in purified water Remarks - Method A group of ten animals were administered a single 2,000 mg/kg oral dose of test substance and were observed for acute toxicity for 14 days. Dosing was performed through gavage. At the end of the observation period all animals were sacrificed by carbon dioxide asphyxiation and subjected to macroscopic necroscopy examination. Group Number and Sex Dose Mortality of Animals mg/kg bw 1 5M & 5F 2,000 none LD50 >2,000 mg/kg bw Signs of Toxicity No evidence Effects in Organs No effect Remarks - Results 500 and 2,000 mg/kg bw doses Preliminary test (2 female test animals): were administered to two female test animals and were observed for 7 days. No clinical symptoms were observed for the 500 mg/kg bw level. Dyspnea and piloerection were observed on day 1 in the animal given the 2,000 mg/kg bw dose. No deaths or signs of systemic toxicity were observed. Main experiment : All animals showed expected gains in the bodyweight over the study period and no abnormalities were noted at necroscopy. The notified chemical if of low acute toxicity by the oral route. Laboratory 2 (2003a) Irritation skin – Notified chemical OECD TG 404 Acute Dermal Irritation/Corrosion. EC Directive 92/69/EEC, B.4
EC Council Regulation No 440/2008 A.9 Flash Point. Remarks Closed cup equilibrium method. Harlan (2011g) Autoignition Temperature > 400 °C EC Council Regulation No 440/2008 A.15 Auto-Ignition Temperature (Liquids and Gases). Harlan (2011h) Appendix B: Toxicological Investigations Acute toxicity – oral Notified chemical OECD TG 420 Acute Oral Toxicity – Fixed Dose Procedure. EC Directive 92/69/EEC, B.1 Species/Strain Rat/Sprague-Dawley Rj:SD (IOPS Han) Vehicle 0.5% suspension of methylcellulose in purified water Remarks - Method A group of ten animals were administered a single 2,000 mg/kg oral dose of test substance and were observed for acute toxicity for 14 days. Dosing was performed through gavage. At the end of the observation period all animals were sacrificed by carbon dioxide asphyxiation and subjected to macroscopic necroscopy examination. Group Number and Sex of Animals Dose mg/kg bw Mortality 1 5M & 5F 2,000 none LD50 >2,000 mg/kg bw Signs of Toxicity No evidence Effects in Organs No effect Remarks - Results Preliminary test (2 female test animals): 500 and 2,000 mg/kg bw doses were administered to two female test animals and were observed for 7 days. No clinical symptoms were observed for the 500 mg/kg bw Dyspnea and piloerection were observed on day 1 in the animal given the 2,000 mg/kg bw dose. Main experiment : No deaths or signs of systemic toxicity were observed. All animals showed expected gains in the bodyweight over the study period and no abnormalities were noted at necroscopy. The notified chemical if of low acute toxicity by the oral route. Laboratory 2 (2003a) Irritation – skin Notified chemical OECD TG 404 Acute Dermal Irritation/Corrosion. EC Directive 92/69/EEC, B.4 level.