90-Day oral toxicity study of D-tagatose in rats.

90-Day oral toxicity study of D-tagatose in rats.
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DOI:
10.1006/rtph.1998.1262
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发表时间:
1999-04
期刊:
Regulatory toxicology and pharmacology : RTP
影响因子:
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通讯作者:
C. Kruger;Margaret H. Whittaker;Vasilios H. Frankos;G. W. Trimmer
C. Kruger;Margaret H. Whittaker;Vasilios H. Frankos;G. W. Trimmer
中科院分区:
其他
文献类型:
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作者:
C. Kruger;Margaret H. Whittaker;Vasilios H. Frankos;G. W. Trimmer

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D-塔格糖是一种己酮糖,味道像糖,可用作低热量甜味剂。为了评估 D-塔格糖的安全性,对雄性和雌性 Crl:CDBR 大鼠进行了一项口服 90 天毒性研究,饮食剂量为 5%、10%、15% 和 20% D-塔格糖。一个对照组(饮食对照组)仅接受实验室食物;第二个对照组的饮食中含有 20% 的纤维素/果糖。饮食中添加 5% D-塔格糖不会产生与治疗相关的影响。在较高剂量下,与治疗相关的影响包括 15% 和 20% 剂量组的雄性和雌性动物出现短暂的软便。预计这是由于大剂量相对未消化的糖的渗透作用的结果,并且不被认为是毒性作用。所有治疗组在研究期间体重均增加;然而,与饮食对照动物相比,在选定的时间间隔内,15%和20%剂量组雄性以及20%剂量组雌性的平均体重在统计学上显着下降。与饮食对照组相比,治疗组的平均食物消耗量没有显着减少。与饮食对照相比,10%、15%和20%剂量组的雄性和雌性动物的相对肝脏重量在统计学上显着增加。没有与这些增加的肝脏重量相关的总体病理学发现。在15%和20%剂量组的雄性和雌性动物中观察到最小的肝细胞肥大。对肝脏切片的独立审查得出结论,与 D-塔格糖相关的组织形态学变化是肝细胞肥大和肝细胞糖原积累受限。因此,得出的结论是,肝脏重量的增加和最小程度的肥大是适应高膳食水平(膳食中大于5%)D-塔格糖的结果。饮食中添加 5% D-塔格糖后未发现任何副作用。
D-tagatose is a ketohexose, tastes like sugar and is useful as a low-calorie sweetener. To assess D-tagatose's safety, an oral 90-day toxicity study was conducted on male and female Crl:CDBR rats at dietary doses of 5, 10, 15, and 20% D-tagatose. One control group (dietary control) received only lab chow; a second control group received 20% cellulose/fructose in the diet. There were no treatment-related effects at 5% D-tagatose in the diet. At higher doses, treatment-related effects included transient soft stools in male and female animals from the 15 and 20% dose groups. This was anticipated as a result of the osmotic effect of a large dose of relatively undigested sugar and was not considered a toxic effect. All treatment groups gained weight over the study period; however, mean body weights were statistically significantly decreased in the 15 and 20% dose-group males and the 20% dose-group females at selected intervals compared to dietary control animals. No significant reduction in mean food consumption was noted in the treatment groups compared to the dietary control. Statistically significantly increased relative liver weights were noted in male and female animals from the 10, 15, and 20% dose groups compared to the dietary control. No gross pathological findings correlated with these increased liver weights. Minimal hepatocellular hypertrophy was observed in male and female animals from the 15 and 20% dose groups. An independent review of the liver slides concluded that histomorphologic changes associated with D-tagatose were restricted hepatocyte hypertrophy and hepatocyte glycogen accumulation. Therefore, it was concluded that increased liver weights and minimal hypertrophy were the result of adaptation to the high dietary levels (greater than 5% in the diet) of D-tagatose. No adverse effects were seen at 5% D-tagatose in the diet.