EC Directive 92/69/EEC A.14 Explosive Properties. US, EPA OPPTS Method 830.6316 Remarks The notified chemical contains no chemical groups that would imply explosive properties, therefore the result has been predicted negative. Safepharm (2004b) Oxidizing Properties Not expected to be oxidising. EC Directive 92/69/EEC A.17 Oxidizing Properties (Solids). Remarks The notified chemical contains no chemical groups that would imply oxidising properties, therefore the result has been predicted negative. Safepharm (2004b) 7. TOXICOLOGICAL INVESTIGATIONS Endpoint Result and Assessment Conclusion Rat, acute oral LD50 >2000 mg/kg bw low toxicity Rat, dermal LD50 > 2000 mg/kg bw low toxicity Rabbit, skin irritation non-irritating Rabbit, eye irritation severely irritating Mouse, skin sensitisation local lymph node assay no evidence of sensitisation – Rat, repeat dose oral toxicity 28 days. NOAEL= 150 mg/kg bw/day – Genotoxicity bacterial reverse mutation non mutagenic in two separate studies – Genotoxicity in vitro chromosomal aberration test non genotoxic in two separate studies – 7.1. Acute toxicity oral – Notified chemical OECD TG 423 Acute Oral Toxicity Acute Toxic Class Method. – Species/Strain Rat/Sprague-Dawley (CD) Vehicle Arachis oil BP Remarks - Method A correction factor was applied to account for substance purity. Group Number and Sex Dose Mortality of Animals mg/kg bw 1 6 females 2000 0/6 LD50 >2000 mg/kg bw of Toxicity The only clinical sign observed was blue staining of faeces and urine. There were no signs of systemic toxicity. Effects in Organs Dark liver in 3 females; dark grey liver in the remaining animals. Remarks - Results None. The notified chemical is of low toxicity via the oral route. SafePharm (2004d) 7.2. Acute toxicity dermal –
EC Directive 92/69/EEC A.14 Explosive Properties. US, EPA OPPTS Method 830.6316 Remarks The notified chemical contains no chemical groups that would imply explosive properties, therefore the result has been predicted negative. Safepharm (2004b) Oxidizing Properties Not expected to be oxidising. EC Directive 92/69/EEC A.17 Oxidizing Properties (Solids). Remarks The notified chemical contains no chemical groups that would imply oxidising properties, therefore the result has been predicted negative. Safepharm (2004b) 7. TOXICOLOGICAL INVESTIGATIONS Endpoint Result and Assessment Conclusion Rat, acute oral LD50 >2000 mg/kg bw low toxicity Rat, dermal LD50 > 2000 mg/kg bw low toxicity Rabbit, skin irritation non-irritating Rabbit, eye irritation severely irritating Mouse, skin sensitisation – local lymph node assay no evidence of sensitisation Rat, repeat dose oral toxicity – 28 days. NOAEL= 150 mg/kg bw/day Genotoxicity – bacterial reverse mutation non mutagenic in two separate studies Genotoxicity – in vitro chromosomal aberration test non genotoxic in two separate studies 7.1. Acute toxicity – oral Notified chemical OECD TG 423 Acute Oral Toxicity – Acute Toxic Class Method. Species/Strain Rat/Sprague-Dawley (CD) Vehicle Arachis oil BP Remarks - Method A correction factor was applied to account for substance purity. Group Number and Sex of Animals Dose mg/kg bw Mortality 1 6 females 2000 0/6 LD50 >2000 mg/kg bw of Toxicity The only clinical sign observed was blue staining of faeces and urine. There were no signs of systemic toxicity. Effects in Organs Dark liver in 3 females; dark grey liver in the remaining animals. Remarks - Results None. The notified chemical is of low toxicity via the oral route. SafePharm (2004d) 7.2. Acute toxicity – dermal
STD1153FR.docx