Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
8550753 | Regulatory Toxicology and Pharmacology | 2018 | 7 Pages |
Abstract
Recent studies suggest that diets supplemented with alpha-linolenic acid (ALA)-enriched diacylglycerol (DAG) oil provide potential health benefits in preventing or managing obesity. However, available safety information about reproductive and developmental toxicities of ALA-DAG oil is limited. This study was conducted to clarify the effect, if any, of ALA-DAG oil on embryo-fetal development, following maternal exposure during the critical period of major organogenesis. ALA-DAG oil was administered via gavage to pre-mated female Sprague Dawley rats from gestation day 6 through 19, at dose levels of 0, 1.25, 2.5, and 5.0â¯mL/kg/day (equivalent to 0, 1149, 2325, and 4715â¯mg/kg/day, respectively), with total volume adjusted to 5â¯mL/kg/day with rapeseed oil. All females survived to the scheduled necropsy. There were no treatment-related changes in clinical or internal findings, maternal body weights, feed consumption, intrauterine growth, survival, and number of implantations. No ALA-DAG oil-related fetal malformations or developmental variations were noted. A maternal maximum tolerated dose for ALA-DAG oil could not be achieved in this study. Based on these results, a dose level of 5.0â¯mL/kg (4715â¯mg/kg/day), the highest dose tested, was considered as the no-observed-adverse-effect level (NOAEL) for both maternal and developmental toxicity.
Keywords
SDGFDANaClONOAELOECDEPAALAGRASS.D.Arachidonic acidalpha-linolenic acidEicosapentaenoic acidalpha linolenic acidstandard deviationgenerally recognized as safeTeratologytriacylglycerolTAG یا triacylglycerols diacylglycerolDAGgestation dayFlaxseed oilFood and Drug AdministrationOrganization for Economic Co-operation and DevelopmentSodium hypochloriteDevelopmental toxicityFood ingredientno-observed-adverse-effect level
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Authors
Hiroto Bushita, Shujie Liu, Takafumi Ohta, Yuichi Ito, Kazutoshi Saito, Yuko Nukada, Naohiro Ikeda, Osamu Morita,