食用色素红曲红的急性和亚慢性经口毒性研究  

Acute and subchronic oral toxicityy studies of food colorant Monascus red

作　　者：王红霞 谭剑斌[2] 黄振峰 王柯新 陈壁锋[2] 林虹[2] 罗曼思 蒋莹 黄雅怡 黄志彪[2] 杨杏芬 赵敏[2] WANG Hong-xia;TAN Jian-bin;HUANG Zhen-feng;WANG Ke-xin;CHEN Bi-feng;LIN Hong;LUO Man-si;JIANG Ying;HUANG Ya-yi;HUANG Zhi-biao;YANG Xing-fen;ZHAO MIN(School of Public Health,Southern Medical University,Guangzhou Guangdong 510515,China;Institute of Toxicology,Guangdong Provincial Center for Disease Control and Prevention,Guangzhou Guangdong 511430,China;School of Biology and Biological Engineering,South China University of Technology,Guangzhou Guangdong 510006,China)

机构地区：[1]南方医科大学公共卫生学院,广东广州510515 [2]广东省疾病预防控制中心卫生毒理所,广东广州511430 [3]华南理工大学生物科学与工程学院,广东广州510006

出　　处：《毒理学杂志》2023年第2期99-107,共9页Journal of Toxicology

基　　金：广东省重点领域研发计划项目(2019B020210002,2019B020210001);广州市科技计划项目(201803010105)。

摘　　要：目的 通过开展食用色素红曲红的急性和亚慢性经口毒性试验,探讨其食用安全性,为红曲红的风险评估和标准修订提供依据。方法 急性经口毒性试验采用限量法。KM种小鼠24 h内一次经口灌胃给予10 g/kg·bw红曲红,观察动物的中毒体征和死亡情况;亚慢性经口毒性试验采用148只SPF级SD种大鼠(雌雄各半),主试验组大鼠经口灌胃给予0.50、1.08、2.32和5.00 g/kg·bw的红曲红90 d,中期和恢复期卫星组大鼠分别经口灌胃给予5.00 g/kg·bw的红曲红45 d, 90 d后继续观察28 d。结果 急性经口毒性试验期间未出现动物中毒反应和死亡,获得雌性和雄性小鼠经口LD50>10 g/kg·bw;亚慢性经口毒性试验期间无动物死亡,红曲红对大鼠一般临床观察、体重和摄食、血液学、血清生化、尿常规、尿生化及病理学指标均无明显影响。结论 红曲红急性经口毒性分级为实际无毒;亚慢性经口毒性雌性和雄性大鼠未观察到有害作用剂量为5.00 g/kg·bw(本试验最高剂量)。Objective To evaluate the acute and subchronic oral toxicity of Monascus red,a food colorant,which will provide a basis for its risk assessment.Methods Method for limit test was used to determine the acute toxicity.KM mice(n=10/sex/group)were administered a single oral exposure of Monascus red with 10 g/kg bw within 24 hours,and the toxic reactions and mortality were evaluated.In the subchronic toxicity study,totally 148 SPF SD rats(sex in half)were used,which were administered by gavage with Monascus red for 90 days consecutive days at doses of 0.50,1.08,2.32 and 5.00 g/kg·bw.Additional two satellite groups underwent the same protocol(5.00 g/kg·bw)for 45 days and for 90 days following 28 days of observation,respectively.ResultsIn the acute toxicity study,no obvious abnormality and mortality were observed in mice,the acute oral LDso of Monascus red to female and male KM mice was more than 10 g/kg.bw.In the subchronic oral toxicity study,no mortality was detected during the experimental period.Monascus red produced no marked adverse alterations on the general clinical signs,body weight,food consumption,haematology,blood biochemistry,urinalysis,urine biochemistry,and no histopathological changes related to the test substance were found.Conclusion Acute oral toxicity of Monascus red was classified as virtually non-toxic.No observed adverse effect level(NOAEL)of Monascus red for 90 days oral administration was 5.00 g/kg·bw,the highest dose tested in male and female rats.

关 键 词：红曲红 食用色素 亚慢性经口毒性 安全性评价 未观察到有害作用剂量 

分 类 号：R114[医药卫生—卫生毒理学] R155[医药卫生—公共卫生与预防医学] R99