7. TOXICOLOGICAL INVESTIGATIONS Endpoint and Result Assessment Conclusion Rat, acute oral LD50 > 2500 mg/kg bw, low toxicity Rat, dermal* LD50 > 2000 mg/kg bw, low toxicity Rat, acute inhalation Not available Rabbit, skin irritation Moderately irritating Rabbit, eye irritation* Severely irritating Mouse, skin sensitisation LLNA** Evidence of sensitisation – Rat, repeat dose oral toxicity 28 days. NOEL = 200 mg/kg bw/day – Genotoxicity bacterial reverse mutation Non mutagenic – Genotoxicity chromosomal Genotoxic – in aberration Genotoxicity micronucleus assay Non genotoxic in vivo – *Analogue chemical **Local lymph node assay The analogue chemical contains reactive functional groups, are likely to contribute to toxicity, e.g., irritation and sensitisation. 7.1. Acute toxicity oral – Notified chemical OECD TG 423 Acute Oral Toxicity Acute Toxic Class Method. – Species/Strain Rat/Sprague-Dawley CD strain rat Vehicle Arachis oil BP Remarks - Method There were no significant deviations from the protocol. Group Number and Sex Dose Mortality of Animals mg/kg bw 1 3 F 2000 0 2 3 F 2000 0 LD50 > 2500 mg/kg bw Signs of Toxicity There were no signs of systemic toxicity. All animals showed expected gains in bodyweight over the study period. Effects in Organs No abnormalities were noted at necropsy. The notified chemical is of low toxicity via the oral SafePharm Laboratories (2004) 7.2. Acute toxicity dermal – Analogue chemical (90%) OECD TG 402 Acute Dermal Toxicity Limit Test. – Species/Strain Rat/Strain unknown Vehicle Unknown Type of dressing Unknown Remarks - Method Unknown Group Number and Sex Dose Mortality of Animals mg/kg bw
7. TOXICOLOGICAL INVESTIGATIONS Endpoint and Result Assessment Conclusion Rat, acute oral LD50 > 2500 mg/kg bw, low toxicity Rat, dermal* LD50 > 2000 mg/kg bw, low toxicity Rat, acute inhalation Not available Rabbit, skin irritation Moderately irritating Rabbit, eye irritation* Severely irritating Mouse, skin sensitisation – LLNA** Evidence of sensitisation Rat, repeat dose oral toxicity – 28 days. NOEL = 200 mg/kg bw/day Genotoxicity – bacterial reverse mutation Non mutagenic Genotoxicity – in chromosomal aberration Genotoxic Genotoxicity – in vivo micronucleus assay Non genotoxic *Analogue chemical **Local lymph node assay The analogue chemical contains reactive functional groups, are likely to contribute to toxicity, e.g., irritation and sensitisation. 7.1. Acute toxicity – oral Notified chemical OECD TG 423 Acute Oral Toxicity – Acute Toxic Class Method. Species/Strain Rat/Sprague-Dawley CD strain rat Vehicle Arachis oil BP Remarks - Method There were no significant deviations from the protocol. Group Number and Sex of Animals Dose mg/kg bw Mortality 1 3 F 2000 0 2 3 F 2000 0 LD50 > 2500 mg/kg bw Signs of Toxicity There were no signs of systemic toxicity. All animals showed expected gains in bodyweight over the study period. Effects in Organs No abnormalities were noted at necropsy. The notified chemical is of low toxicity via the oral SafePharm Laboratories (2004) 7.2. Acute toxicity – dermal Analogue chemical (90%) OECD TG 402 Acute Dermal Toxicity – Limit Test. Species/Strain Rat/Strain unknown Vehicle Unknown Type of dressing Unknown Remarks - Method Unknown Group Number and Sex of Animals Dose mg/kg bw Mortality
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