Human Health Hazard Summary Table Phthalate Carcinogenicity Fertility Acute Irritation & Repeated Dose Genetic Developmental Toxicity Sensitisation Toxicity Toxicity Toxicity Di-n-octyl Oral Skin Irritation: Oral In In Continuous breeding Continuous breeding phthalate Rat: ME Rat: Bacterial No data study (DnOP) LD50 = 53700 NOAEL = 37 mg/kg mutation assays Mouse: Mouse: mg/kg bw Eye Irritation: bw/d and direct DNA In vivo: NOAEL = 7500 mg/kg NOAEL = 7500 mg/kg ME damage assays: Rat: Liver nodules bw/d (highest dose bw/d (highest dose Dermal LOAEL = 350 mg/kg Negative following 15 month tested) tested) Guinea pig: Respiratory bw/d dietary administration LD50 = 75 Irritation: Ultrastructural In vivo: LOAEL: NE LOAEL: NE mL/kg bw Insufficient data changes in liver and No data Rat: 26 week dietary thyroid. gamma- ↑ Inhalation Skin glutamyltransferase- No data Sensitisation: High doses: liver positive foci in liver ↑ Negative weight, vacuolisation and necrosis; ↓ centrilobular glycogen. PP not generally noted. ME minimal effects; NE not established; PP peroxisome proliferation – – –
Human Health Hazard Summary Table Phthalate Acute Toxicity Irritation & Sensitisation Repeated Dose Toxicity Genetic Toxicity Carcinogenicity Fertility Developmental Toxicity Di-n-octyl phthalate (DnOP) Oral Rat: LD50 = 53700 mg/kg bw Dermal Guinea pig: LD50 = 75 mL/kg bw Inhalation No data Skin Irritation: ME Eye Irritation: ME Respiratory Irritation: Insufficient data Skin Sensitisation: Negative Oral Rat: NOAEL = 37 mg/kg bw/d LOAEL = 350 mg/kg bw/d Ultrastructural changes in liver and thyroid. High doses: ↑ liver weight, vacuolisation and necrosis; ↓ centrilobular glycogen. PP not generally noted. In Bacterial mutation assays and direct DNA damage assays: Negative In vivo: No data In No data In vivo: Rat: Liver nodules following 15 month dietary administration Rat: 26 week dietary ↑ gamma- glutamyltransferase- positive foci in liver Continuous breeding study Mouse: NOAEL = 7500 mg/kg bw/d (highest dose tested) LOAEL: NE Continuous breeding Mouse: NOAEL = 7500 mg/kg bw/d (highest dose tested) LOAEL: NE ME – minimal effects; NE – not established; PP – peroxisome proliferation
DnOP-hazard-assessment.docx