Rat, acute oral Notified chemical low toxicity, LD50 16,900 22,400 – mg/kg bw Rat, acute dermal 2-Pyrrolidone low toxicity, LD50 > 2000 mg/kg bw Rat, inhalation 2-Pyrrolidone Not highly toxic, LC50 > 0.28 mg/L/8 h Rabbit, skin irritation Notified chemical non-irritating Rabbit, eye irritation Notified chemical slightly irritating Guinea pig, skin sensitisation Notified chemical no evidence of sensitisation test. Rat, repeat dose oral toxicity 90 2-Pyrrolidone NOAEL 207 mg/kg bw/day – days. Genotoxicity bacterial reverse Notified chemical non mutagenic – mutation a) Genotoxicity bacterial reverse Notified chemical mutagenic – mutation b) Genotoxicity bacterial reverse Notified chemical mutagenic – mutation c) Genotoxicity bacterial reverse Notified chemical mutagenic – mutation d) Genotoxicity in vitro Sister Notified chemical weakly clastogenic – Chromatid Exchange Assay Genotoxicity in vitro Notified chemical not clastogenic – Chromosome Aberration Test Genotoxicity in vitro Notified chemical weakly clastogenic – Mammalian Cell Gene Mutation Test Genotoxicity in vitro Notified chemical not clastogenic – Mammalian Cell Transformation Assay Genotoxicity in vivo 2-Pyrrolidone non genotoxic – Mammalian Erythrocyte Micronucleus Test 7.1 Toxicity Oral 7.1.1 Acute toxicity oral a) – Notified chemical Species/Strain Rat/Wistar Vehicle Remarks Method A one page summary of the study was supplied. The rats were fasted for – approximately 18 hours prior to administration of the test material. The material was given orally by intubation on a g/kg basis. Following treatment the animals were returned to their cages and food and water were freely available. The rats were observed for signs of toxicity and pharmacological effects for 14 days following treatment. Necropsies were inadvertently not performed. Group Number and Sex Dose Mortality of Animals mg/kg bw 1 10 male 5000 2 2 10 male 7120 0 3 10 male 10,140 0 4 10 male 14,430 0
Rat, acute oral Notified chemical low toxicity, LD50 16,900 – 22,400 mg/kg bw Rat, acute dermal 2-Pyrrolidone low toxicity, LD50 > 2000 mg/kg bw Rat, inhalation 2-Pyrrolidone Not highly toxic, LC50 > 0.28 mg/L/8 h Rabbit, skin irritation Notified chemical non-irritating Rabbit, eye irritation Notified chemical slightly irritating Guinea pig, skin sensitisation test. Notified chemical no evidence of sensitisation Rat, repeat dose oral toxicity – 90 days. 2-Pyrrolidone NOAEL 207 mg/kg bw/day Genotoxicity – bacterial reverse mutation a) Notified chemical non mutagenic Genotoxicity – bacterial reverse mutation b) Notified chemical mutagenic Genotoxicity – bacterial reverse mutation c) Notified chemical mutagenic Genotoxicity – bacterial reverse mutation d) Notified chemical mutagenic Genotoxicity – in vitro Sister Chromatid Exchange Assay Notified chemical weakly clastogenic Genotoxicity – in vitro Chromosome Aberration Test Notified chemical not clastogenic Genotoxicity – in vitro Mammalian Cell Gene Mutation Test Notified chemical weakly clastogenic Genotoxicity – in vitro Mammalian Cell Transformation Assay Notified chemical not clastogenic Genotoxicity – in vivo Mammalian Erythrocyte Micronucleus Test 2-Pyrrolidone non genotoxic 7.1 Toxicity Oral 7.1.1 Acute toxicity – oral a) Notified chemical Species/Strain Rat/Wistar Vehicle Remarks – Method A one page summary of the study was supplied. The rats were fasted for approximately 18 hours prior to administration of the test material. The material was given orally by intubation on a g/kg basis. Following treatment the animals were returned to their cages and food and water were freely available. The rats were observed for signs of toxicity and pharmacological effects for 14 days following treatment. Necropsies were inadvertently not performed. Group Number and Sex of Animals Dose mg/kg bw Mortality 1 10 male 5000 2 2 10 male 7120 0 3 10 male 10,140 0 4 10 male 14,430 0
STD1134FR.docx