title: Subchronic toxicity study in vivo and allergenicity study in vitro for genetically modified rice that expresses pharmaceutical protein (human serum albumin).
abstract: Genetically modified (GM) crops that express pharmaceutical proteins have become an important focus of recent genetic engineering research. Food safety assessment is necessary for the commercial development of these crops. Subchronic toxicity study in vivo and allergenicity study in vitro were designed to evaluate the food safety of the rice variety expressing human serum albumin (HSA). Animals were fed rodent diets containing 12.5%, 25.0% and 50.0% GM or non-GM rice for 90 days. The composition analysis of the GM rice demonstrated several significant differences. However, most of the differences remained within the ranges reported in the literature. In the animal study, a range of indexes including clinical observation, feed efficiency, hematology, serum chemistry, organ weights and histopathology were examined. Random changes unrelated to the GM rice exposure, within the range of historical control values and not associated with any signs of illness were observed. The results of heat stability and in vitro digestion of HSA indicated no evidence of potential allergenicity of the protein. Overall, the results of these studies suggest that the GM rice appears to be safe as a dietary ingredient when it is used at up to 50% in the diet on a subchronic basis.
authors.affiliation: College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, China.
authors.forename: Yao
authors.initials: Y
authors.lastname: Sheng
authors.affiliation: College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, China.
authors.forename: Xiaozhe
authors.initials: X
authors.lastname: Qi
authors.affiliation: College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, China.
authors.forename: Yifei
authors.initials: Y
authors.lastname: Liu
authors.affiliation: College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, China.
authors.forename: Mingzhang
authors.initials: M
authors.lastname: Guo
authors.affiliation: College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, China.
authors.forename: Siyuan
authors.initials: S
authors.lastname: Chen
authors.affiliation: College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, China; The Supervision, Inspection and Testing Center of Genetically Modified Organisms, Ministry of Agriculture, Beijing 100083, China.
authors.forename: Xiaoyun
authors.initials: X
authors.lastname: He
authors.affiliation: College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, China; The Supervision, Inspection and Testing Center of Genetically Modified Organisms, Ministry of Agriculture, Beijing 100083, China.
authors.forename: Kunlun
authors.initials: K
authors.lastname: Huang
authors.affiliation: College of Food Science and Nutritional Engineering, China Agricultural University, Beijing 100083, China; The Supervision, Inspection and Testing Center of Genetically Modified Organisms, Ministry of Agriculture, Beijing 100083, China. Electronic address: xuwentao@cau.edu.cn.
authors.forename: Wentao
authors.initials: W
authors.lastname: Xu
mesh_terms: D000485:Allergens / Q000633:toxicity*; D000818:Animals; D003257:Consumer Product Safety; D005260:Female; D059022:Food Safety; D030841:Food, Genetically Modified / Q000633:toxicity*; D006801:Humans; D008297:Male; D009929:Organ Size; D012275:Oryza / Q000235:genetics* / Q000276:immunology / Q000633:toxicity; D030821:Plants, Genetically Modified / Q000276:immunology / Q000633:toxicity*; D051381:Rats; D017207:Rats, Sprague-Dawley; D012709:Serum Albumin / Q000235:genetics* / Q000378:metabolism; D059550:Toxicity Tests, Subchronic
chemical_list: D000485:Allergens; D012709:Serum Albumin
keywords: Genetically modified rice; Human serum albumin; Pharmaceutical protein; Safety assessment