Oral and dermal developmental toxicity studies of phenylethyl alcohol in rats

Int J Toxicol. 2013 Jan-Feb;32(1):32-8. doi: 10.1177/1091581812461811.

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Cutaneous
  • Administration, Oral
  • Animals
  • Dose-Response Relationship, Drug
  • Embryonic Development / drug effects*
  • Female
  • Fetal Development / drug effects*
  • Fetal Weight / drug effects
  • Gestational Age
  • Maternal Exposure*
  • Musculoskeletal Abnormalities / chemically induced
  • No-Observed-Adverse-Effect Level
  • Phenylethyl Alcohol / toxicity*
  • Pregnancy
  • Rats
  • Rats, Inbred Strains
  • Ribs / abnormalities
  • Ribs / drug effects
  • Toxicity Tests

Substances

  • Phenylethyl Alcohol