title: Developmental toxicity evaluation of esterified propoxylated glycerol (EPG) administered in the diet to New Zealand white rabbits.
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.
authors.affiliation: RTI International, 3040 E. Cornwallis Road, Research Triangle Park, PO Box 12194, NC, United States.
authors.forename: Rochelle W
authors.initials: RW
authors.lastname: Tyl
authors.affiliation: Best Foods, Division of CPC International, 150 Pierce St., Somerset, NJ 08873, United States. Electronic address: david.bechtel@intertek.com.
authors.forename: David H
authors.initials: DH
authors.lastname: Bechtel
mesh_terms: D000818:Animals; D004032:Diet; D019358:Fat Substitutes / Q000633:toxicity*; D005260:Female; D047109:Fetal Development / Q000187:drug effects; D005989:Glycerides / Q000633:toxicity*; D008431:Maternal-Fetal Exchange; D019055:No-Observed-Adverse-Effect Level; D011247:Pregnancy; D011817:Rabbits; D012098:Reproduction / Q000187:drug effects
chemical_list: D019358:Fat Substitutes; D005989:Glycerides
keywords: EPG; Esterified propoxylated glycerol; Fat substitute; Reproductive toxicity; Teratogenicity