Reynolds R C, Chappel C I
Corporate Health, Safety, and Environment, Eastman Kodak Company, Rochester, NY 14652, USA.
Food Chem Toxicol. 1998 Feb;36(2):81-93. doi: 10.1016/s0278-6915(97)80300-6.
Sucrose acetate isobutyrate (SAIB), a mixture of esters of sucrose with a composition approximating the name sucrose diacetate hexaisobutyrate, has been used for over 30 yr in many countries as a 'weighting' or 'density-adjusting' agent in non-alcoholic carbonated and non-carbonated beverages. As part of the demonstration of safety of SAIB as a direct food additive in human diets, a program of toxicity testing was started in the late 1950s that culminated in extensive studies of SAIB in rodents, monkeys and humans over the last decade. This review summarizes the toxicity data, accrued up until 1988, that precede the safety studies published elsewhere in this issue. SAIB has been shown to have very low acute and chronic toxicities in rats, monkeys, and, except for effects on the liver, in dogs at feeding levels of up to 10% in the diet. Slight effects seen in rats and monkeys at levels of 10% in the diet are unlikely to be directly caused by exposure to SAIB. In dogs, however, SAIB causes decreases in bromosulfophthalein (BSP) and indocyanine green (ICG) elimination from the serum immediately following a single dose, indicative of interference with biliary excretion. On repeated feeding in dogs, SAIB caused increases in serum alkaline phosphatase levels, but enzymes indicative of toxic effects on the liver were unaffected. On prolonged feeding to dogs, SAIB caused changes in liver morphology revealed by electron microscopy. All of these effects were reversed when SAIB was withdrawn from the diet. The no-effect level for these effects in dogs was near 5 mg/kg body weight, but these effects were not seen in rats fed up to 4 g/kg body weight/day, monkeys fed up to 10 g/kg body weight/day, or humans fed up to 20 mg/kg body weight/day. The toxicity and pharmacological studies in dogs, rats and monkeys suggest that the effect of SAIB on biliary excretion and liver morphology in dogs is essentially pharmacological rather than toxicological in nature and that the difference between the effects in dogs at levels as low as 5 mg/kg body weight/day, and the lack of effects in rats or monkeys at levels up to 10 g/kg/day is not merely a quantitative difference between species, but an absolute qualitative difference.
蔗糖乙酸异丁酸酯（SAIB）是蔗糖酯的混合物，其成分近似于蔗糖二乙酸六异丁酸酯，在许多国家已被用作非酒精碳酸饮料和非碳酸饮料中的“增重”或“密度调节”剂长达30多年。作为SAIB作为人类饮食中直接食品添加剂安全性论证的一部分，20世纪50年代末启动了一项毒性测试计划，该计划在过去十年中对SAIB在啮齿动物、猴子和人类身上进行了广泛研究。本综述总结了截至1988年积累的毒性数据，这些数据先于本期其他地方发表的安全性研究。在大鼠、猴子以及除对肝脏有影响外的狗身上，当饮食中SAIB含量高达10%时，已证明其急性和慢性毒性非常低。在饮食中含量为10%时，在大鼠和猴子身上看到的轻微影响不太可能直接由接触SAIB引起。然而，在狗身上，单次给药后，SAIB会导致血清中溴磺酞钠（BSP）和吲哚菁绿（ICG）的清除率下降，这表明对胆汁排泄有干扰。在狗身上反复喂食SAIB会导致血清碱性磷酸酶水平升高，但表明对肝脏有毒性作用的酶未受影响。长期给狗喂食SAIB会导致电子显微镜下显示的肝脏形态变化。当从饮食中撤掉SAIB时，所有这些影响都得到了逆转。狗身上这些影响的无作用水平接近5毫克/千克体重，但在每天喂食高达4克/千克体重的大鼠、每天喂食高达10克/千克体重的猴子或每天喂食高达20毫克/千克体重的人类身上未看到这些影响。在狗、大鼠和猴子身上进行的毒性和药理学研究表明，SAIB对狗胆汁排泄和肝脏形态的影响本质上是药理学性质而非毒理学性质，并且在每天低至5毫克/千克体重的水平下对狗的影响与在每天高达10克/千克体重的水平下大鼠或猴子未出现影响之间的差异不仅是物种间的数量差异，而且是绝对的质量差异。
