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Wedig J.,T.P.S Inc. | Bechtel D.H.,Best Foods
Regulatory Toxicology and Pharmacology

The subchronic (90-day) toxicity of esterified propoxylated glycerol (EPG) was assessed in micropigs. Animals (5/sex/group) received feed containing 5%, 10%, and 17% EPG, mixed accordingly throughout the study to deliver 1.5, 3, and 5. g/kg bw/day of EPG, respectively. Corn oil served as the vehicle control (0. g/kg bw/day). Subsets of animals were evaluated at Week 6; the remainder between Weeks 12 and 14. With the exception of liver and serum vitamin levels, statistically significant difference between control and EPG groups were seen sporadically, and with no apparent connection to treatment and/or no consistency across time intervals. EPG intakes of 3 and 5. g/kg. bw/day, but not at 1.5. g/kg. bw/day were associated with significantly lower serum 25-OH vitamin D levels. Serum total vitamin D levels were significantly lower across all EPG groups. There were also trends toward lower levels of liver vitamins A and E among EPG-treated animals, but the effects were less consistent. The effects on vitamin levels observed in EPG-treated animals were not accompanied by any signs of vitamin deficiency (e.g., effects on growth, clinical signs, or clinical pathology), and might have been related to the larger mass of EPG acting as a lipid "sink" during transit in the gastrointestinal tract. © 2014 Elsevier Inc. Source

Christian B.J.,Hazelton Wisconsin Inc. | Bechtel D.H.,Best Foods
Regulatory Toxicology and Pharmacology

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 2. g/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 2. g/kg and 5% EPG level were considered to represent a no-observable-adverse-effect levels (NOAELs). © 2014 Elsevier Inc. Source

Tyl R.W.,Rti International | Bechtel D.H.,Best Foods
Regulatory Toxicology and Pharmacology

This one-generation study assessed the potential of esterified propoxylated glycerol (EPG) to affect reproduction and offspring development in rats. Male and female Crl:CD(SD)BR rats (30/sex/group) were exposed to EPG at 0, 0.5, 1, and 2g/kgbw/day or at 5% (w/w) in the diet prior to (13weeks), during, and after two consecutive matings. For dams, exposure continued through gestation and lactation; F1a and F1b pups were weaned to the respective diet (for up to 91days). No consistent treatment-related effects were observed in: body weights/gains; feed consumption; clinical observations; mating indices; survival, growth and development of litters, litter sizes, body weights, sex ratios (lower % males/litter at 1 and 2g/kgbw/day), acquisition of developmental landmarks, behavioral indices, or histology of selected organs. Lower serum vitamin D, liver vitamin A, and liver vitamin E levels were seen in some EPG-treated groups. None of the reductions were judged to be biologically significant. A/G ratio was greater among males receiving 2g/kgbw/day and 5%. In the absence of any other related effects, the biological significance of this finding is doubtful. © 2014 Elsevier Inc. Source

Bechtel D.H.,Best Foods
Regulatory Toxicology and Pharmacology

This article introduces a series of articles addressing the safety of esterified propoxylated glycerols (EPGs), a family of fat- and oil-like substances that resemble triglycerides in structure and appearance, but have been modified to prevent or limit their digestion when consumed in food. A general summary of the history, composition, metabolism, and safety of EPGs is provided. © 2014 Elsevier Inc. Source

A solid form of esterified propoxylated glycerol (EPG) was administered to 16 healthy male volunteers in butter-like spread and baked goods, resulting in intakes that rose in 30-g increments from 30 to 150 g; each level was administered on a single day, followed by a 2-day washout period. Elevated serum transaminase (ALT and/or AST) and lower HDL cholesterol levels were noted at 60 g and greater, possibly related to changes in the diet (high-carbohydrate and increasingly low-fat), rather than to EPG itself. There was no apparent association between EPG consumption and adverse effects reported. In general, EPG had no effect on bowel function, except in a single subject, who reported increased frequency of movements during the 2 days that followed consumption of 150 g EPG. All abnormal values returned to normal after the study, and subjects were otherwise asymptomatic. Accordingly, the effects on transaminase and HDL levels observed in this study were considered possibly adaptive and not clinically significant. Experimental animal studies, including lifetime studies, had shown no effects on these parameters. More importantly, the effect was associated with intakes of 60-150 g EPG, which exceeds the approximate intake of 20 g/day or less expected from currently intended commercial food uses. © 2015 The Author. Source

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