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安赛蜜对大鼠的亚慢性毒性

Subchronic toxicity study of acesulfame in rats
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摘要 目的:研究安赛蜜作为食品添加剂的亚慢性毒性。方法:按照GB 15193.13—2015的方法进行亚慢性毒性试验,采用4周龄无特定病原体(SPF)级健康离乳Sprague Dawley(SD)大鼠80只,雌雄各半,设置4个剂量组,分别为阴性对照组和安赛蜜4500,1500,500 mg/kg体重3个剂量组,对大鼠进行90 d灌胃染毒,试验结束采血测定血常规及生化指标并进行病理学检测对比。结果:安赛蜜4500,1500,500 mg/kg体重3个剂量组动物一般体征正常,试验末期体重增长量、总摄食量、总食物利用率以及绝对脏器重量、脏体比未发现有意义的异常改变;血液学检测值、生化指标检测值、尿液指标值均在正常波动范围内,与对照组比较差异无统计学意义(P>0.05)。动物大体检查未发现心、肝、脾、肺、肾、睾丸、心脏、胸腺和肾上腺等脏器的异常改变,组织病理学镜检未发现与受试物相关的病理改变。结论:安赛蜜在整个试验周期对大鼠均未见明显的毒性作用,90 d经口未观察到有害作用剂量为4500 mg/kg体重。 Objective:This study aimed to study the subchronic toxicity of acesulfame as a food additive and obtain the dosage of harmful effects not observed orally for 90 d.Methods:According to GB 15193.13—2015,eighty 4-week-old specific pathogen-free(SPF)healthy detached Sprague Dawley(SD)rats(half male and half female)were randomly divided into 4 groups.Rats were administered 4500,1500,500 and 0.0 mg/kg BW.acesulfame by gavage for 90 consecutive days,respectively.At the end of the experiment,samples of blood were collected for blood routine and biochemical analysis,and some organs were removed for histopathological examinations.All the data of the rats were compared and evaluated with the control group.Results:The general physical signs of animals in the 3 dosage groups of acesulfame 4500,1500 and 500 mg/kg BW.were normal,and no significant abnormal changes were found in the body weight gain,total food intake,total food utilization rate,absolute organ weight,and viscera/body ratio at the end of the experiment.The values of hematology,biochemical indexes,and urine indexes were all within the normal fluctuation range,and there was no significant difference between the 3 experimental groups and the control group(P>0.05).Gross examination showed no abnormal changes in the heart,liver,spleen,lung,kidney,testis,heart,thymus and adrenal glands.Histopathological examination also showed no pathological changes related to the subject.Conclusion:Acesulfame has no obvious toxic effects on rats during the whole test period,the NOAEL of male and female SD rats in oral subchronic toxicity study for acesulfame both are 4500 mg/kg BW.
作者 郑思雨 滕晶晶 杨同金 王岩 夏新 鲍军辉 ZHENG Siyu;TENG Jingjing;YANG Tongjin;WANG Yan;XIA Xin;BAO Junhui(Anhui Provincial Center for Disease Control and Prevention,Heifei,Anhui 230601,China)
出处 《食品与机械》 CSCD 北大核心 2023年第11期23-28,37,共7页 Food and Machinery
基金 中央补助食品安全风险监测及标准跟踪评价项目(编号:皖卫财秘[2021] 191号)。
关键词 安赛蜜 大鼠 亚慢性毒性 经口毒性试验 acesulfame rat subchronic toxicity oral toxicity test
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