title: A 52-week safety study in cynomolgus macaques for genetically modified rice expressing Cry1Ab/1Ac protein.
abstract: A 52-week feeding study in cynomolgus macaques was carried out to evaluate the safety of Bt rice Huahui 1 (HH1), a transgenic rice line expressing Cry1Ab/1Ac protein. Monkeys were fed a diet with 20% or 60% HH1 rice, 20% or 60% parental rice (Minghui 63, MH63), normal diet, normal diet spiked with purified recombinant Cry1Ab/1Ac fusion protein or bovine serum albumin (BSA) respectively. During the feeding trail, clinical observations were conducted daily, and multiple parameters, including body weight, body temperature, electrocardiogram, hematology, blood biochemistry, serum metabolome and gut microbiome were examined at regular intervals. Upon sacrifice, the organs were weighted, and the macroscopic, microscopic and electron microscopic examinations were performed. The results show no adverse or toxic effects of Bt rice HH1 or Cry1Ab/1Ac fusion protein on monkeys. Therefore, the present 52-week primate feeding study suggests that the transgenic rice containing Cry 1Ab/1Ac is equivalent to its parental rice line MH63.
authors.affiliation: State Key Laboratory of Proteomics, Institute of Basic Medical Sciences, National Center of Biomedical Analysis, 27 Tai-Ping Road, Beijing 100850, China.
authors.forename: Jie
authors.initials: J
authors.lastname: Mao
authors.affiliation: State Key Laboratory of Proteomics, Institute of Basic Medical Sciences, National Center of Biomedical Analysis, 27 Tai-Ping Road, Beijing 100850, China.
authors.forename: Xing
authors.initials: X
authors.lastname: Sun
authors.affiliation: State Key Laboratory of Proteomics, Institute of Basic Medical Sciences, National Center of Biomedical Analysis, 27 Tai-Ping Road, Beijing 100850, China.
authors.forename: Jian-Hua
authors.initials: JH
authors.lastname: Cheng
authors.affiliation: State Key Laboratory of Proteomics, Institute of Basic Medical Sciences, National Center of Biomedical Analysis, 27 Tai-Ping Road, Beijing 100850, China.
authors.forename: Yong-Jie
authors.initials: YJ
authors.lastname: Shi
authors.affiliation: State Key Laboratory of Proteomics, Institute of Basic Medical Sciences, National Center of Biomedical Analysis, 27 Tai-Ping Road, Beijing 100850, China.
authors.forename: Xin-Zheng
authors.initials: XZ
authors.lastname: Wang
authors.affiliation: State Key Laboratory of Proteomics, Institute of Basic Medical Sciences, National Center of Biomedical Analysis, 27 Tai-Ping Road, Beijing 100850, China.
authors.forename: Jun-Jie
authors.initials: JJ
authors.lastname: Qin
authors.affiliation: State Key Laboratory of Proteomics, Institute of Basic Medical Sciences, National Center of Biomedical Analysis, 27 Tai-Ping Road, Beijing 100850, China.
authors.forename: Zhi-Hong
authors.initials: ZH
authors.lastname: Sang
authors.affiliation: State Key Laboratory of Proteomics, Institute of Basic Medical Sciences, National Center of Biomedical Analysis, 27 Tai-Ping Road, Beijing 100850, China.
authors.forename: Kun
authors.initials: K
authors.lastname: He
authors.affiliation: State Key Laboratory of Proteomics, Institute of Basic Medical Sciences, National Center of Biomedical Analysis, 27 Tai-Ping Road, Beijing 100850, China. Electronic address: qxia@ncba.ac.cn.
authors.forename: Qing
authors.initials: Q
authors.lastname: Xia
mesh_terms: D000818:Animals; D000083722:Bacillus thuringiensis Toxins; D001426:Bacterial Proteins / Q000378:metabolism*; D002417:Cattle; D004032:Diet; D004731:Endotoxins / Q000378:metabolism*; D005260:Female; D059022:Food Safety; D000069196:Gastrointestinal Microbiome; D006460:Hemolysin Proteins / Q000378:metabolism*; D008252:Macaca fascicularis; D008297:Male; D055442:Metabolome; D009929:Organ Size; D012275:Oryza / Q000235:genetics / Q000378:metabolism*; D030821:Plants, Genetically Modified / Q000235:genetics / Q000378:metabolism*; D040901:Proteomics; D018570:Risk Assessment; D012710:Serum Albumin, Bovine / Q000378:metabolism
chemical_list: D000083722:Bacillus thuringiensis Toxins; D001426:Bacterial Proteins; D004731:Endotoxins; D006460:Hemolysin Proteins; C030956:insecticidal crystal protein, Bacillus Thuringiensis; D012710:Serum Albumin, Bovine
keywords: Bacillus thuringiensis; Cynomolgus macaque; Genetically modified rice; Safety assessment