A 90-day repeated-dose toxicity study of dietary alpha linolenic acid-enriched diacylglycerol oil in rats

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作   者：

Bushita, Hiroto;  Ito, Yuichi;  Saito, Tetsuji;  Nukada, Yuko;  Ikeda, Naohiro;  Nakagiri, Hideaki;  Saito, Kazutoshi;  Morita, Osamu; 

作者机构：

Drug Dev Serv Segment;  LSI Med Corp;  Kao Corp;  R&D Safety Sci Res;  Tokyo 1318501;  Japan;  Kumamoto Safety Assessment Dept;  2-1-3 Bunka;  Sumida Ku;  1285;  2606 Akabane;  Nonclin Res Ctr;  Tochigi 3213497;  Ichikai; 

关键词：

Diacylglycerol oil;  Repeated-dose toxicity;  Food ingredient;  Alpha linolenic acid;  Flaxseed oil;  Subchronic toxicity; 

期刊名称：

Regulatory Toxicology and Pharmacology: RTP

i s s n：

0273-2300

年卷期：

2018 年 97 卷

页   码：

33-47

页   码：

摘   要：

Diets supplemented with alpha-linolenic acid (ALA)-enriched diacylglycerol (DAG) oil-which mainly consists of oleic and linolenic, linoleic acids-have potential health benefits in terms of preventing or managing obesity. Although safety of DAG oil has been extensively investigated, toxicity of ALA-DAG oil has not been well understood. Hence, the present study was conducted to clarify the potential adverse effects, if any, of ALA-DAG oil in rats (10/sex/group) fed diets containing 1.375%, 2.75%, or 5.5% ALA-DAG oil for 90 days. Compared to control rats fed rapeseed oil or ALA-triacylglycerol oil (flaxseed oil), rats receiving ALA-DAG oil did not reveal any toxicologically significant treatment-related changes as evaluated by clinical signs, functional observational battery, body weight, food consumption, ophthalmology, urinalysis, hematology, clinical chemistry, organ weight, necropsy and histopathology. The no observed adverse effect levels for dietary exposure to ALA-DAG oil for male and female rats were 2916 and 3326 mg/kg body weight/day, respectively, the highest dose tested. The findings from this study suggest that consumption of ALA-DAG oil is unlikely to cause adverse effects.