Effects of dietary diacylglycerol oil on embryo/fetal development in rats.
Diacylglycerol (DAG) oil is an edible oil with similar taste and usability characteristics as conventional edible oil. Recent studies suggest that use of DAG oil may be helpful in the prevention and management of obesity. This study evaluated the potential maternal and fetal effects of DAG oil, following exposure to pregnant rats, during the critical period of major organogenesis. DAG oil was administered via gavage to four groups of mated female Crl:CD(SD)IGS BR rats (25/group) once daily from gestation day 6 through 17, at dose levels of 0, 1.25, 2.5 or 5.0 ml/kg/day (0, 1160, 2320 and 4630 mg/kg/day) with total volume made to 5 ml/kg/day with triacylglycerol (corn) oil. No mortality or treatment-related clinical or internal findings were noted in any of the groups. Compared to animals in control group, mean maternal body weights, body weight gains, net body weights, net body weight gains, gravid uterine weights, and food consumption were not affected by DAG oil administration. Similarly, intrauterine growth and survival were not affected by DAG oil administration. No DAG oil-related fetal malformations or developmental variations were noted. A maternal maximum tolerated dose for DAG oil was not achieved in this study. Based on the results of this study, a dose level of 5.0 ml/kg (4630 mg/kg/day) was considered as no-observed-adverse-effect level (NOAEL) for both maternal and developmental toxicity.
Morita
Osamu
O
Global R&D Safety Science, Kao Corporation, 2606 Akabane, Ichikai-machi, Haga-gun, Tochigi-ken 321-3497, Japan. morita.osamu@kao.co.jp
Knapp
John F
JF
Tamaki
Yasushi
Y
Varsho
Bennett J
BJ
Stump
Donald G
DG
Nemec
Mark D
MD
D000014:Abnormalities, Drug-Induced; D000284:Administration, Oral; D000818:Animals; D019440:Anti-Obesity Agents / Q000633:toxicity; D004075:Diglycerides / Q000633:toxicity*; D004305:Dose-Response Relationship, Drug; D004622:Embryo, Mammalian / Q000187:drug effects*; D005260:Female; D047109:Fetal Development / Q000187:drug effects*; D020567:Fetal Weight / Q000187:drug effects*; D018811:Maternal Exposure; D019055:No-Observed-Adverse-Effect Level; D009929:Organ Size; D011247:Pregnancy; D011897:Random Allocation; D051381:Rats; D017207:Rats, Sprague-Dawley; D015430:Weight Gain
D019440:Anti-Obesity Agents; D004075:Diglycerides