title: 90-day dietary toxicity study with esterified propoxylated glycerol (EPG) in rats.
abstract: The subchronic (90-day) toxicity of a "core" version of EPG was assessed in rats. Crl:CD-1®(ICR)BR rats (70/sex) received diets containing a constant level of 5% EPG (w/w) or adjusted to deliver 0 (control), 0.5, 1, or 2g/kg of body weight/day (g/kg bw/day). Subsets of animals from each group (20/sex) were evaluated after 30 days (interim sacrifice); the remainder after 90 days. EPG intake at all dose levels was associated with lower mean liver vitamin E levels; liver vitamin A and serum vitamin D were also lower, but less consistently. Animals given 5% EPG had higher fecal output (males) and cholesterol (males and females) without corresponding changes in serum cholesterol. Urinary pH was also mildly lower in males given 5% EPG. However, detailed evaluation of general health and assessment of blood, organs and tissues showed no evidence that EPG administration compromised the nutritional requirements of the animals, caused a state of fat-soluble vitamin deficiency, or caused' toxicity to any organ system. Based on the results of this study, it was not possible to establish a no-observable-effect level (NOEL). The possible effect of EPG on vitamin levels in the absence of any clinical signs of deficiency was not considered "adverse" per se. As such, the 2g/kg and 5% EPG level were considered to represent a no-observable-adverse-effect levels (NOAELs).
authors.affiliation: Hazelton Wisconsin, Inc., 3301 Kinsman Blvd, Madison, WI 53704, United States.
authors.forename: Brian J
authors.initials: BJ
authors.lastname: Christian
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; D002784:Cholesterol / Q000378:metabolism; D004032:Diet; D019358:Fat Substitutes / Q000633:toxicity*; D005227:Fatty Acids / Q000378:metabolism; D005243:Feces / Q000737:chemistry; D005260:Female; D005989:Glycerides / Q000633:toxicity*; D008099:Liver / Q000187:drug effects / Q000378:metabolism; D008297:Male; D019055:No-Observed-Adverse-Effect Level; D051381:Rats; D059550:Toxicity Tests, Subchronic; D014801:Vitamin A / Q000378:metabolism; D014807:Vitamin D / Q000097:blood; D014810:Vitamin E / Q000378:metabolism
chemical_list: D019358:Fat Substitutes; D005227:Fatty Acids; D005989:Glycerides; D014801:Vitamin A; D014807:Vitamin D; D014810:Vitamin E; D002784:Cholesterol
keywords: EPG; Esterified propoxylated glycerol; Fat substitute; Subchronic oral toxicity