Dai Yani, Yang Xuezhen, Liu Shen, Wang Jianwu, Zhou Qixian, Fang Rui, Yu Tian
Wuxi KGBIO Technology Co. , Ltd. , Wuxi 214145, China.
Wei Sheng Yan Jiu. 2018 Mar;47(2):286-311.
To study the edible safety of recombinant human lactoferrin( rh LF) expressed from transgenic cow mammary gland bioreactor.
According to the food additive safety toxicology evaluation procedures and method, acute oral toxicity in rats and 90 day subchronic toxicity test in mice were done to evaluate the edible safety of rh LF.
Acute oral toxicity test indicated that rh LF was no toxic effect during the observation period, mouse acute oral LD50 of recombinant human lactoferrin was greater than 20 000 mg/kg. 90 days feeding test indicated that there was no-observedadverse-effect-level after givening 300 times rh LF recommended dose of animals body, toxicological parameters NOAEL was 10. 00 g/( kg·d).
According to the acute toxic dose graduation standard, rh LF was nonpoisonous. Rh LF was no-observedadverse-effect-level and no subchronic toxicity after givening 300 times rh LF recommended dose of animals body. According to the result, rh LF was no potential food safety risk.
研究转基因奶牛乳腺生物反应器表达的重组人乳铁蛋白（rhLF）的食用安全性。
按照食品添加剂安全性毒理学评价程序与方法，进行大鼠急性经口毒性试验和小鼠90天亚慢性毒性试验，以评价rhLF的食用安全性。
急性经口毒性试验表明，在观察期内rhLF无毒性作用，重组人乳铁蛋白小鼠急性经口LD50大于20000mg/kg。90天喂养试验表明，给予动物300倍rhLF推荐剂量后未观察到不良作用水平，毒理学参数NOAEL为10.00g/（kg·d）。
根据急性毒性剂量分级标准，rhLF属无毒物质。给予动物300倍rhLF推荐剂量后未观察到不良作用水平，也无亚慢性毒性。根据试验结果，rhLF不存在潜在的食品安全风险。
