7. TOXICOLOGICAL INVESTIGATIONS Toxicological tests were performed on products containing analogous chemicals Endpoint and Result Assessment Conclusion Rat, acute oral LD50 >2000 mg/kg bw low toxicity Rat, acute dermal LD50 >2000 mg/kg bw low toxicity Rat, acute inhalation not performed Rabbit, skin irritation slightly irritating Rabbit, eye irritation slightly irritating Guinea pig, skin sensitisation test. limited evidence of sensitisation –non-adjuvant Rat, repeat dose dermal toxicity 28 days. NOAEL > 1000 mg/kg bw/day – Genotoxicity bacterial reverse mutation non mutagenic – Genotoxicity in vitro mammalian chromosome aberration test non genotoxic – Genotoxicity in vivo mammalian bone marrow chromosome non genotoxic – aberration test 7.1. Acute toxicity oral – Analogous chemical. OECD TG 401 Oral Toxicity Limit Test. – Species/Strain Rat/Crl:CD BR Vehicle None. Remarks - Method No significant protocol deviations. Group Number and Sex Dose Mortality of Animals mg/kg bw 1 5/sex 2000 0 LD50 >2000 mg/kg bw Signs of Toxicity No signs of toxicity observed. Effects in Organs No abnormalities observed. Remarks - Results No significant protocol deviations. The analogue chemical is of low toxicity via the oral EBS (1997a) 7.2. Acute toxicity dermal – Analogous chemical. OECD TG 402 Acute Dermal Toxicity Limit Test. – EC Directive 92/69/EEC B.3 Acute Toxicity (Dermal) Limit Test. – Species/Strain Rabbit/New Zealand White Vehicle None. Type of dressing Occlusive. Remarks - Method No significant protocol deviations.
7. TOXICOLOGICAL INVESTIGATIONS Toxicological tests were performed on products containing analogous chemicals Endpoint and Result Assessment Conclusion Rat, acute oral LD50 >2000 mg/kg bw low toxicity Rat, acute dermal LD50 >2000 mg/kg bw low toxicity Rat, acute inhalation not performed Rabbit, skin irritation slightly irritating Rabbit, eye irritation slightly irritating Guinea pig, skin sensitisation –non-adjuvant test. limited evidence of sensitisation Rat, repeat dose dermal toxicity – 28 days. NOAEL > 1000 mg/kg bw/day Genotoxicity – bacterial reverse mutation non mutagenic Genotoxicity – in vitro mammalian chromosome aberration test non genotoxic Genotoxicity – in vivo mammalian bone marrow chromosome aberration test non genotoxic 7.1. Acute toxicity – oral Analogous chemical. OECD TG 401 Oral Toxicity – Limit Test. Species/Strain Rat/Crl:CD BR Vehicle None. Remarks - Method No significant protocol deviations. Group Number and Sex of Animals Dose mg/kg bw Mortality 1 5/sex 2000 0 LD50 >2000 mg/kg bw Signs of Toxicity No signs of toxicity observed. Effects in Organs No abnormalities observed. Remarks - Results No significant protocol deviations. The analogue chemical is of low toxicity via the oral EBS (1997a) 7.2. Acute toxicity – dermal Analogous chemical. OECD TG 402 Acute Dermal Toxicity – Limit Test. EC Directive 92/69/EEC B.3 Acute Toxicity (Dermal) – Limit Test. Species/Strain Rabbit/New Zealand White Vehicle None. Type of dressing Occlusive. Remarks - Method No significant protocol deviations.
STD1151-FR.docx