title: A 90-day safety study of genetically modified rice expressing rhIGF-1 protein in C57BL/6J rats.
abstract: Genetically modified plants expressing disease resistance traits offer new treatment strategies for human diseases, but at the same time present a challenge in terms of food safety assessment. The present 90-day feeding study was designed to assess the safety of transgenic rice expressing the recombinant human insulin-like growth factor-1 (rhIGF-1) compared to its parental wild rice. Male and female C57BL/6J rats were given a nutritionally balanced purified diet with 20% transgenic rhIGF-1 rice or 20% parental rice for 90 days. This corresponds to a mean daily rhIGF-1 protein intake of approximately 217.6 mg/kg body weight based on the average feed consumption. In the animal study a range of biological, biochemical, clinical, microbiological and pathological parameters were examined and several significant differences were observed between groups, but none of the effects were considered to be adverse. In conclusion, no adverse or toxic effects on C57BL/6J rats were observed in the design used in this 90-day study. These results will provide valuable information for the safety assessment of genetically modified food crops.
authors: State Key Laboratory for Animal Nutrition and Beijing Inspection Test Center for Biosafety of Genetically Modified Animal and Feed of the Ministry of Agriculture of China, Institute of Animal Sciences, Chinese Academy of Agricultural Sciences, Beijing 100193, People's Republic of China.
authors: Maoxue
authors: M
authors: Tang
authors: Tingting
authors: T
authors: Xie
authors: Wenke
authors: W
authors: Cheng
authors: Lili
authors: L
authors: Qian
authors: Shulin
authors: S
authors: Yang
authors: Daichang
authors: D
authors: Yang
authors: Wentao
authors: W
authors: Cui
authors: Kui
authors: K
authors: Li
mesh_terms: D000818:Animals; D058491:Bacterial Load; D001774:Blood Chemical Analysis; D001786:Blood Glucose / Q000378:metabolism; D001835:Body Weight; D005243:Feces / Q000382:microbiology; D005260:Female; D059022:Food Safety / Q000379:methods*; D030841:Food, Genetically Modified / Q000633:toxicity*; D006801:Humans; D007334:Insulin-Like Growth Factor I / Q000235:genetics / Q000378:metabolism*; D008297:Male; D051379:Mice; D008810:Mice, Inbred C57BL; D012275:Oryza / Q000235:genetics / Q000633:toxicity*; D030821:Plants, Genetically Modified / Q000235:genetics / Q000378:metabolism* / Q000633:toxicity*; D011786:Quality Control; D011994:Recombinant Proteins / Q000235:genetics / Q000378:metabolism; D013997:Time Factors
chemical_list: D001786:Blood Glucose; D011994:Recombinant Proteins; D007334:Insulin-Like Growth Factor I