Key Laboratory of Food Safety Risk Assessment, Ministry of Health, China National Center for Food Safety Risk Assessment, Beijing, 100021, China.
Key Laboratory of Food Safety Risk Assessment, Ministry of Health, China National Center for Food Safety Risk Assessment, Beijing, 100021, China.
Regul Toxicol Pharmacol. 2021 Jul;123:104943. doi: 10.1016/j.yrtph.2021.104943. Epub 2021 Apr 30.
In the present study, a new genetically modified rice producing phytase-lactoferricin fusion protein, BPL9K-4, was evaluated for safety in a 90-day rat feeding study. Rats were fed rodent diets formulated with BPL9K-4 rice, and were compared with rats fed diets formulated with its corresponding non-transgenic parental rice 9 K, commercially available non-transgenic rice Weiyou64, and a basal diet. BPL9K-4 and 9 K rice were formulated into diets at concentrations of 15%, 30% and 60%, and Weiyou64 common rice was added to diets at concentration of 60%. AIN93G diet was set as a basal-diet control. Diets of all groups were fed to rats (10/sex/group) for 90 days. Compared with rats in the 9 K, Weiyou64 and the basal-diet group, rats fed the BPL9K-4 diet did not show any treatment-related adverse effects on mortality, body weights, feed consumption, clinical chemistry, hematology, organ weights and gross and microscopic pathology. Under the conditions of this study, the genetically modified BPL9K-4 diets did not cause any toxicologically significant effects in rats following 90 days of dietary administration as compared with rats fed diets with the corresponding non-transgenic control diet and the basal-diet group. The results indicated that BPL9K-4 rice is as safe as its conventional comparators.
在本研究中，一种新型的生产植酸酶-乳铁蛋白融合蛋白的转基因水稻 BPL9K-4，在 90 天大鼠喂养研究中进行了安全性评估。大鼠喂食含 BPL9K-4 水稻的啮齿动物饲料，并与喂食其相应的非转基因亲本水稻 9K、市售非转基因水稻 Weiyou64 和基础饲料的大鼠进行比较。BPL9K-4 和 9K 水稻以 15%、30%和 60%的浓度制成饲料，而 Weiyou64 普通水稻以 60%的浓度添加到饲料中。AIN93G 饲料被设定为基础饲料对照。所有组别的饲料均喂食给大鼠（每组 10 只/性别）90 天。与 9K、Weiyou64 和基础饲料组的大鼠相比，喂食 BPL9K-4 饲料的大鼠在死亡率、体重、饲料消耗、临床化学、血液学、器官重量和大体及显微镜病理学方面没有表现出任何与治疗相关的不良反应。在本研究条件下，与喂食相应的非转基因对照饲料和基础饲料组的大鼠相比，喂食 BPL9K-4 转基因饲料 90 天后，大鼠未出现任何毒理学上显著的影响。结果表明，BPL9K-4 水稻与常规对照品一样安全。
