Developmental toxicity evaluation of esterified propoxylated glycerol (EPG) administered in the diet to New Zealand white rabbits

Regul Toxicol Pharmacol. 2014 Dec:70 Suppl 2:S123-30. doi: 10.1016/j.yrtph.2014.11.014. Epub 2014 Dec 8.

Abstract

The safety of a "core" version of esterified propoxylated glycerols (EPGs) was assessed in a developmental toxicity study in New Zealand white rabbits, Hra:(NZW)SPF. Four groups each of 18 inseminated female rabbits received diets ad libitum containing concentrations of 0%, 2.5%, 5%, and 10% EPG (w/w) with 6% corn oil (w/w). No treatment-related effects were observed in any maternal toxicity parameter, including maternal body weight and weight gain, feed consumption, or clinical signs of toxicity. There were no statistically significant treatment-related effects in gestational parameters, including pre- and post-implantation loss, litter size, sex ratio, fetal body weight, and crown-rump length. The incidences of fetal external, visceral, and skeletal malformations or variations were also comparable across groups. A no-observable-adverse-effect level (NOAEL) of 10% EPG (approximately 4.76 g/kg bw/day) for both maternal and developmental toxicity is proposed based on the results of this study.

Keywords: EPG; Esterified propoxylated glycerol; Fat substitute; Reproductive toxicity; Teratogenicity.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Diet
  • Fat Substitutes / toxicity*
  • Female
  • Fetal Development / drug effects
  • Glycerides / toxicity*
  • Maternal-Fetal Exchange
  • No-Observed-Adverse-Effect Level
  • Pregnancy
  • Rabbits
  • Reproduction / drug effects

Substances

  • Fat Substitutes
  • Glycerides