Safety assessment of dietary diacylglycerol oil: A two-generation reproductive toxicity study in rats

• Published in: Food and chemical toxicology Vol. 46; no. 9; pp. 3059 - 3068
• Main Authors: Morita, Osamu, Knapp, John F., Tamaki, Yasushi, Nemec, Mark D., Varsho, Bennett J., Stump, Donald G.
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier Ltd 01-09-2008; New York, NY Elsevier Science
• Subjects: adverse effects; animal models; Animals; Biological and medical sciences; Body Weight - drug effects; carcinogenesis; Diacylglycerol oil; diacylglycerols; Diet; dietary fat; Diglycerides - toxicity; Eating - drug effects; enzymatic hydrolysis; Estrous Cycle - drug effects; fat intake; fatty acid composition; Female; fetotoxicity; Food ingredient; food safety; Food toxicology; genotoxicity; gestation period; health promotion; histopathology; in vitro studies; in vivo studies; Lactation - drug effects; lactation stage; Litter Size - drug effects; long term effects; Male; mating disruption; Medical sciences; No-Observed-Adverse-Effect Level; Organ Size - drug effects; Parturition - drug effects; plant fats and oils; Pregnancy; pregnancy complications; pregnancy outcome; Protein kinase C; Rats; Rats, Sprague-Dawley; Reproduction - drug effects; Reproductive toxicity; reproductive toxicology; safety testing; Sexual Behavior, Animal - drug effects; Sexual Maturation; Spermatogenesis - drug effects; toxicity testing; Toxicology; Weaning; FDA; Protein kinase C; TPA; PND; PKC; DAG; MAG; Diacylglycerol oil; Food ingredient; Reproductive toxicity; NOAEL; LD; TAG; GnRH; GRAS; GD; Reproduction diseases; Rat; Enzyme; Toxicity; Transferases; Rodentia; Diacylglycerol; Multigeneration study; Lipids; Edible oil; Vertebrata; Mammalia; Animal; Food
• ISSN: 0278-6915; 1873-6351
• DOI: 10.1016/j.fct.2008.06.008

Diacylglycerol (DAG) oil is a novel edible oil with similar taste and usability characteristics as conventional edible oils. Recent studies suggest that DAG oil may be helpful in the prevention and management of obesity. The objective of the present two-generation study was to evaluate potential adverse effects of DAG oil on reproductive processes. DAG oil was administered via gavage to rats (30/sex/group) for at least 70 days prior to mating, at dose levels of 0, 1.25, 2.5 or 5.0
ml/kg/day (0, 1160, 2320 and 4630
mg/kg/day). An additional group received a triacylglycerol (TAG) oil with a similar fatty acid composition to DAG oil. The rats were treated throughout the mating, gestation and lactation periods. Administration of DAG or TAG oil did not reveal any toxicologically significant effects on reproductive performance (mating, fertility and copulation/conception indices). DAG oil did not affect mean gestation lengths, the process of parturition, spermatogenic parameters, organ weights, histopathologic findings, mean numbers of pups born, implantation sites and unaccounted sites. F1 and F2 pup viability, live litter sizes, body weights, mean age of attainment of balanopreputial separation and vaginal patency were similar to those in the control group. Based on the results of this study, a dose level of 5.0
ml/kg (4630
mg/kg/day) was considered as the no-observed-adverse-effect level for reproductive and systemic toxicity, and neonatal toxicity.