Safety Evaluation of Diacylglycerol Microemulsion in Rats/Mice

doi:10.1016/S1671-2927(11)60101-6

摘要/Abstract

摘要： The objective of the present study was to evaluate potential adverse effects of diacylglycerol microemulsion (DAGM) inrats/mice. Acute safety evaluation was carried out by giving intragastrically with 20 mL 25% DAG kg-1 body weight ofDAGM or water with two groups of mice. Chronic safety evaluation with 40 male and 40 female Sprague-Dawley rats wascarried out by setting a control group and 3 different dose groups (n=10 male+10 female) administered with DAGM with6.7, 10 and 20 mL kg-1 body weight per day. Relevant parameters of liver and kidney function and biochemistry weredetermined by standard methods at end point. Acute toxicity study revealed the maximum tolerated dose (MTD) ofDAGM was 20 mL kg-1 body weight in mice. No death was observed at the dose of 20 mL kg-1 body weight per day. Chronicsafety evaluation did not show significant changes on hematological, histopathologic, clinical, and biochemical testswhen administered at levels of 6.7, 10 and 20 mL kg-1 body weight per day to rats for 30 d. No significant body weightchanges were observed in different dosages in both male and female rats. Our results suggested that acute and chronicadverse effects were not observed in histology and clinical parameters in both mice and rats. The results suggested thatDAGM is safe at the experimental levels.

关键词:

safety evaluation, diacylglycerol microemulsion, acute safety, chronic safety

Abstract: The objective of the present study was to evaluate potential adverse effects of diacylglycerol microemulsion (DAGM) inrats/mice. Acute safety evaluation was carried out by giving intragastrically with 20 mL 25% DAG kg-1 body weight ofDAGM or water with two groups of mice. Chronic safety evaluation with 40 male and 40 female Sprague-Dawley rats wascarried out by setting a control group and 3 different dose groups (n=10 male+10 female) administered with DAGM with6.7, 10 and 20 mL kg-1 body weight per day. Relevant parameters of liver and kidney function and biochemistry weredetermined by standard methods at end point. Acute toxicity study revealed the maximum tolerated dose (MTD) ofDAGM was 20 mL kg-1 body weight in mice. No death was observed at the dose of 20 mL kg-1 body weight per day. Chronicsafety evaluation did not show significant changes on hematological, histopathologic, clinical, and biochemical testswhen administered at levels of 6.7, 10 and 20 mL kg-1 body weight per day to rats for 30 d. No significant body weightchanges were observed in different dosages in both male and female rats. Our results suggested that acute and chronicadverse effects were not observed in histology and clinical parameters in both mice and rats. The results suggested thatDAGM is safe at the experimental levels.

Key words:

safety evaluation, diacylglycerol microemulsion, acute safety, chronic safety

HUANG Tao, CHEN Ying, SHOU Tian-xing, YANG Jing, LI Duo. Safety Evaluation of Diacylglycerol Microemulsion in Rats/Mice[J]. Journal of Integrative Agriculture, 2011, 10(7): 1117-1124.

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