6. Human Health Hazard Summary Table Phthalate Toxicity Irritation & Repeated Dose Genetic Carcinogenicity Fertility Developmental Sensitisation Toxicity Toxicity Toxicity Diisodecyl Oral In vitro: Rat: Skin Irritation: Oral In vitro: Two-generation study Rat: phthalate ME Rat: Negative in Positive in 1 of 2 cell NOAEL = 0.8%; Rat: (DIDP) LD50 >29100 NOAEL = 60 bacterial transformation assays. 427-927 (m-f) NOAEL = 0.06% (38-114 mg/kg bw mutation assays mg/kg bw/d Eye Irritation: mg/kg bw/d. mg/kg bw/d) ME LOAEL = 120 and mouse In vivo: No data NE = 0.2% (134-352 mg/kg bw/d (f): ↑ Rat: Skin assays weight. mg/kg bw/d): pup ↓ LD50 >2910 Sensitisation: survival in F2 mg/kg bw negative In vivo: Dogs: Negative in NOAEL = 15 Gestation study Inhalation: mouse mg/kg bw/d. Rat: Rat: micronuclei LOAEL = 75 NOAEL = 500 mg/kg LC50 >12.54 assay bw/d mg/kg bw/d: liver ↑ mg/L/4h LOAEL = 1000 mg/kg weight (low reliability). bw/d: skeletal ↑ variations (cervical and lumbar ribs) High doses: liver ↑ and kidney weight; nephropathy (m); PP noted. ME minimal effects; NE - not established; PP peroxisome proliferation; m male; f female – – – –
6. Human Health Hazard Summary Table Phthalate Toxicity Irritation & Sensitisation Repeated Dose Toxicity Genetic Toxicity Carcinogenicity Fertility Developmental Toxicity Diisodecyl phthalate (DIDP) Oral Rat: LD50 >29100 mg/kg bw Rat: LD50 >2910 mg/kg bw Inhalation: Rat: LC50 >12.54 mg/L/4h Skin Irritation: ME Eye Irritation: ME Skin Sensitisation: negative Oral Rat: NOAEL = 60 mg/kg bw/d. LOAEL = 120 mg/kg bw/d (f): ↑ weight. Dogs: NOAEL = 15 mg/kg bw/d. LOAEL = 75 mg/kg bw/d: ↑ liver weight (low reliability). High doses: ↑ liver and kidney weight; nephropathy (m); PP noted. In vitro: Negative in bacterial mutation assays and mouse assays In vivo: Negative in mouse micronuclei assay In vitro: Positive in 1 of 2 cell transformation assays. In vivo: No data Rat: NOAEL = 0.8%; 427-927 (m-f) mg/kg bw/d NE Two-generation study Rat: NOAEL = 0.06% (38-114 mg/kg bw/d) = 0.2% (134-352 mg/kg bw/d): ↓ pup survival in F2 Gestation study Rat: NOAEL = 500 mg/kg bw/d LOAEL = 1000 mg/kg bw/d: ↑ skeletal variations (cervical and lumbar ribs) ME – minimal effects; NE - not established; PP – peroxisome proliferation; m – male; f – female
DIDP-hazard-assessment.docx