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

Regul Toxicol Pharmacol

Best Foods, Division of CPC International, 150 Pierce St., Somerset, NJ 08873, United States. Electronic address:

Published: December 2014

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.

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http://dx.doi.org/10.1016/j.yrtph.2014.11.014DOI Listing

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