化橘红胎毒理学安全性评价  

Toxicological safety evaluation on Citrus grandis fructus immaturus

作　　者：彭宝莹 汤莉[1] 王凤岩[1] 张紫虹[1] 周轶琳[1] 陈美芬[1] 黄志彪[1] 李欣[1] PENG Bao-ying;TANG Li;WANG Feng-yan;ZHANG Zi-hong;ZHOU Yi-lin;CHEN Mei-fen;HUANG Zhi-biao;LI Xin(Institute of Toxicology,Guangdong Provincial Center for Disease Control and Prevention,Guangzhou,Guangdong 511430,China)

机构地区：[1]广东省疾病预防控制中心卫生毒理所,广东广州511430

出　　处：《毒理学杂志》2024年第6期461-466,476,共7页Journal of Toxicology

基　　金：广东省医学科学技术研究基金项目(C2023005);梅州市2023年农业领域应用基础研究项目(2023C0301001)。

摘　　要：目的对化橘红胎的食用安全性进行毒理学评价。方法按照食品安全国家标准开展小鼠急性经口毒性试验、3项遗传毒性试验、28 d经口毒性试验,并进行统计分析。结果在本试验条件下,昆明种小鼠摄入化橘红胎后均未表现出急性经口毒效应,急性经口半数致死量(lethal dose 50,LD_(50))大于20.0 g/kg·bw,该物质属实际无毒级;3项遗传毒性试验(哺乳动物红细胞微核试验、Ames试验和体外哺乳类细胞染色体畸变试验)结果均为阴性;28 d经口毒性试验中,化橘红胎各剂量组(2.50、5.00和10.00 g/kg·bw)动物与对照组比较,体重、摄食量和食物利用率结果正常;血液学、血液生化指标、尿液指标和组织病理学检查均未见特异的毒性改变。化橘红胎的未观察到有害作用剂量(no observed adverse effect level,NOAEL)大于10.0 g/kg·bw。结论化橘红胎属实际无毒级物质,本试验条件下化橘红胎未观察到遗传毒性,化橘红胎大鼠28 d经口毒性试验NOAEL>10.0 g/kg·bw。Objective To evaluate the toxicity on Citrus grandis fructus immaturus.Methods Acute oral toxicity test,three genotoxicity tests and repeated dose 28-day oral toxicity test were conducted according to the current national food safety standards.Statistical analysis was conducted.Results In the acute oral toxicity test,no acute oral toxic effect was found induced by on Citrus grandis fructus immaturus in KM mice,and its LD_(50)was greater than 20.0 g/kg·bw,thus,the Citrus grandis fructus immaturus was classified as the actual non-toxic level.The result were negative in three genotoxicity tests.In the repeated dose 28-day oral toxicity test,compared with the control group,no significant toxic effects were found on the body weight,food intake,food utilization rate,hematology,blood biochemistry,urinalysis and histopathology in all animals of each dose group.The NOAEL of Citrus grandis fructus immaturus was greater than 10.0 g/kg·bw.Conclusion Citrus grandis fructus immaturus is classified as actually non-toxic grade.Genetic toxicity was not observed under the conditions of these experiments.The NOAEL of repeated dose 28-day oral toxicity test for Citrus grandis fructus immaturus was greater than 10.0 g/kg·bw.

关 键 词：化橘红胎 毒理学 安全性评价 

分 类 号：R114[医药卫生—卫生毒理学] R99[医药卫生—公共卫生与预防医学]