title: Oral and dermal developmental toxicity studies of phenylethyl alcohol in rats.
abstract: Phenylethyl alcohol (PEA) was tested for developmental toxicity. Pregnant rats were fed 0, 83, 266, or 799 mg/kg/d PEA on gestation days (GDs) 6 to 15; only minimal, nonsignificant effects were observed. In dermal studies, PEA (neat) was applied to the skin on GDs 6 to 15 at dosages of 0, 140, 430, or 1400 mg/kg/d and at 0, 70, 140, 280, 430, or 700 mg/kg/d in a corroborative study. Observations included maternal and embryo-fetal toxicity/abnormalities at 1400 mg/kg/d, increased incidences of rudimentary cervical ribs at ≥430 mg/kg/d, and reduced fetal body weights at ≥140 mg/kg/d. Dermal maternal and developmental no-observed-adverse-effect levels are 70 mg/kg/d, based on dermal irritation and reductions (nonsignificant) in fetal body weights. Human exposure from fragrances is 0.02 mg/kg/d, resulting in a margin of safety >2600, when marked differences in dermal absorption between rats and humans are considered. Under normal fragrance use conditions, PEA is not a developmental toxicity hazard for humans.
authors: Research Institute for Fragrance Materials, Inc, 50 Tice Boulevard, Woodcliff Lake, NJ 07677, USA.
authors: Valerie T
authors: VT
authors: Politano
authors: Robert M
authors: RM
authors: Diener
authors: Mildred S
authors: MS
authors: Christian
authors: Alan M
authors: AM
authors: Hoberman
authors: Anthony
authors: A
authors: Palmer
authors: Gretchen
authors: G
authors: Ritacco
authors: Timothy B
authors: TB
authors: Adams
authors: Anne Marie
authors: AM
authors: Api
mesh_terms: D000279:Administration, Cutaneous; D000284:Administration, Oral; D000818:Animals; D004305:Dose-Response Relationship, Drug; D047108:Embryonic Development / Q000187:drug effects*; D005260:Female; D047109:Fetal Development / Q000187:drug effects*; D020567:Fetal Weight / Q000187:drug effects; D005865:Gestational Age; D018811:Maternal Exposure; D009139:Musculoskeletal Abnormalities / Q000139:chemically induced; D019055:No-Observed-Adverse-Effect Level; D010626:Phenylethyl Alcohol / Q000633:toxicity*; D011247:Pregnancy; D051381:Rats; D011919:Rats, Inbred Strains; D012272:Ribs / Q000002:abnormalities / Q000187:drug effects; D018675:Toxicity Tests
chemical_list: D010626:Phenylethyl Alcohol