Abstract
Evaluating exogenous protein expressed in transgenic crops is one of the most effective methods of assessing the safety of transgenic plants. The objective of this study was to assess the food safety of genetically modified (GM) rice containing a lysine-rich fusion protein gene (transgenic GL gene rice) by in vitro digestion and acute toxicity testing of exogenous protein, according to the national standard of the People’s Republic of China. The exogenous protein was rapidly degraded in the simulated gastric and intestinal fluids. In the acute experiment, the exogenous protein was injected into Institute of Cancer Research (ICR) mice via the tail vein at a dose of 438 mg kg−1 body weight. No adverse effects on animal behavior or mortality were observed during the following 15-day period and there were no significant biological changes in body weight, serum biochemistry parameters, relative organ weights or histopathological examinations, compared with the control group. Therefore, exogenous protein in transgenic GL gene rice has a low potential allergenicity or toxicity risk.
Article PDF
Similar content being viewed by others
Avoid common mistakes on your manuscript.
References
FAO. The State of Food and Agriculture 2003–2004. Agricultural biotechnology: Meeting the Needs of the Poor? Food and Agriculture Organization of the United Nations, Rome, Italy. 2004
IRRI. IRRI Rice Almanac. Manila, The Philippines. 1993
FAO. Rice in human nutrition. Food and Agriculture Organization, Rome. 1993
Gao Y F, Jing Y X, Shen S H, et al. Transfer of lysine-rich protein gene into rice and production of fertile transgenic plants. Acta Bot Sin, 2001, 43: 506–511
Tang L, Liu Q Q, Deng X X, et al. LRP transgenic indica rice restorer line without resistance selection marker (in Chinese). Acta Agron Sin, 2006, 32: 1248–1251
Yu J J, Peng P, Zhang X J, et al. Seed-specific expression of a lysine rich protein sb401 gene significantly increases both lysine and total protein content in maize seeds. Mol Breed, 2004, 14: 1–7
Falco S C, Guida T, Locke M, et al. Transgenic canola and soybean seeds with increased lysine. Biotechnology (NY), 1995, 13: 577–582
Jones L. Science, medicine, and the future, genetically modified foods. BMJ, 1999, 318: 581–584
Delaney B. Strategies to evaluate the safety of bioengineered foods. Int J Toxicol, 2007, 26: 389–399
Sorochinskii B V, Burlaka O M, Naumenko V D, et al. Unintended effects of genetic modifications and methods of their analysis in plants. Cytol Genet, 2011, 45: 324–332
Halford N G, Shewry P R. Genetically modified crops: Methodology, benefits, regulation and public concerns. Br Med Bull, 2000, 56: 62–73
Mosely B E B. Safety assessment and public concern for genetically modified food products: The European view. Toxicol Pathol, 2002, 30: 129–131
Chinese Standard GB15193. 1-2003. Procedures for toxicological assessment of food. 2003
OECD. tSafety evaluation of foods derived by modern biotechnology: Concepts and principles, Organisation for Economic Cooperation and Development, Paris, 1993
FAO/ WHO. Biotechnology and food safety. Report of a joint FAO/WHO consultation, FAO food and nutrition Paper 61, Food and Agriculture Organization of the United Nations, Rome, Italy. 1996
FAO/ WHO. Report of a joint FAO/WHO expert consultation on foods derived from biotechnology. Topic 2: application of substantial equivalence data collection and analyses. Food and Agriculture Organization of the United Nations, Geneva, Switzerland. 2000
Hérouet C, Esdaile D J, Mallyon B A, et al. Safety evaluation of the phosphinothricin acetyltransferase proteins encoded by the pat and bar sequences that confer tolerance to glufosinate-ammonium herbicide in transgenic plants. Regul Toxicol Pharmacol, 2005, 41: 134–149
Lu Y, Xu W T, Kang A, et al. Prokaryotic expression and allergenicity assessment of hygromycin B phosphotransferase protein derived from genetically modified plants. J Food Sci, 2007, 27: 232–288
Delaney B, Zhang J, Carlson G, et al. A gene-shuffled glyphosate acetyltransferase protein from Bacillus licheniformis (GAT4601) shows no evidence of allergenicity or toxicity. Toxicol Sci, 2008, 102: 425–432
Delaney B, Astwood J D, Cunny H, et al. Evaluation of protein safety in the context of agricultural biotechnology. Food Chem Toxicol, 2008, 46: S71–97
Xu W T, Cao S S, He X Y, et al. Safety assessment of Cry1Ab/Ac fusion protein. Food Chem Toxicol, 2009, 47: 1459–1465
Cao S S, He X Y, Xu W T, et al. Safety assessment of Cry1C protein from genetically modified rice according to the national standards of PR China for a new food resource. Regul Toxicol Pharmacol, 2010, 58: 474–481
Domingo J L, Giné Bordonaba J. A literature review on the safety assessment of genetically modified plants. Environ Int, 2011, 37: 734–742
Liu Q Q. Genetically engineering rice for increased lysine (in Chinese). Doctoral Dissertation. Yangzhou: Yangzhou University, 2002
MOA. Ministry of Agriculture of PR China No. 869 Bulletin 2-2007. Food safety detection of genetically modified organisms and derived products. Method of target protein digestive stability in simulative gastric and intestinal fluid (in Chinese), 2007
Yamagata H, Sugimoto T, Tanaka K, et al. Biosynthesis of storage proteins in developing rice seeds. Plant Physiol, 1982, 70: 1094–1100
Sambrook J, Russell D W. Molecular Cloning. A Laboratory Manual. 3rd ed. New York: Cold Spring Harbor Laboratory Press, 1999
Herouet-Guicheney C, Rouquié D, Freyssinet M, et al. Safety evaluation of the double mutant 5-enol pyruvylshikimate-3-phosphate synthase (2mEPSPS) from maize that confers tolerance to glyphosate herbicide in transgenic plants. Regul Toxicol Pharmacol, 2009, 54: 143–153
The Chinese Nutrition Society. Dietary guidelines and the Food Guide Pagoda. J Am Diet Assoc, 2000, 100: 886–887
Shi Y, Mei S C. Practical Handbook of Medical Animal Experiment. Beijing: China Agriculture Press, 2002. 28–31
Schmidt J O. Toxinology of venoms from the honeybee genus apis. Toxicon, 1995, 33: 917–927
Hu J W, Lu S M, Che L P, et al. A probe into normal levels of hematological and biochemical indexes in 10 kinds of common SPF rats and mice (in Chinese). Lab Anim Sci, 2007, 24: 5–10
Dong Y, Shi W D, Zhou X H, et al. A 90-day toxicology study of transgenic rice expressing lysine-rich protein fusion gene in Sprague-Dawley rats (in Chinese). Sci Agric Sin, 2011, 44: 2768–2776
Zhou X H, Dong Y, Wang Y, et al. A three generation study with high-lysine transgenic rice in Sprague-Dawley rats. Food Chem Toxicol, 2012, 50: 1902–1910
Zhou X H. Toxicological studies on the food safety of two transgenic rice (in Chinese). Doctoral Dissertation. Zhengjiang: Jiangsu University, 2012
Chassy B M. Food safety evaluation of crops produced through biotechnology. J Am Coll Nutr, 2002, 21: 166S–173S
Astwood J D. Stability of food allergens to digestion in vitro. Nat Biotechnol, 1996, 14: 1269–1273
Moreno F J. Gastrointestinal digestion of food allergens: Effect on their allergenicity. Biomed Pharmacother, 2007, 61: 50–60
Taylor S L, Hefle S L. Will genetically modified foods be allergenic? Curr Rev Allergy Clin Immunol, 2001, 107: 765–771
Taylor S L. Protein allergenicity assessment of foods produced through agricultural biotechnology. Annu Rev Pharmacol Toxicol, 2002, 42: 99–112
Momma K, Hashimoto W, Ozawa S, et al. Quality and safety evaluation of genetically engineered rice with soybean glycinin: Analyses of the grain composition and digestibility of glycinin in transgenic rice. Biosci Biotechnol Biochem, 1999, 63: 314–318
Privalle L S. Phosphomannose isomerase, a novel plant selection system: Potential allergenicity assessment. Ann NY Acad Sci, 2002. 964: 129–138
Richards H A, Han C T, Hopkins R G, et al. Safety assessment of recombinant green fluorescent protein orally administered to weaned rats. J Nutr, 2003, 133: 1909–1912
Hu X L. Allergenicity and acute toxicity studies of exogenous protein in transgenic rice expressing lysine-rich fusion proteins (in Chinese). Master Dissertation. Yangzhou: Yangzhou University, 2012
Merriman T. An acute oral toxicity study in mice with (inert ingredient): Lab project number: DGC-95-A18:3406.2:3406.1. Prepared by DEKALB Genetics Corp and Springborn Laboratories (SLI), 1996. 50
Author information
Authors and Affiliations
Corresponding authors
Additional information
This article is published with open access at Springerlink.com
Rights and permissions
This article is published under an open access license. Please check the 'Copyright Information' section either on this page or in the PDF for details of this license and what re-use is permitted. If your intended use exceeds what is permitted by the license or if you are unable to locate the licence and re-use information, please contact the Rights and Permissions team.
About this article
Cite this article
Zhao, X., Hu, X., Tang, T. et al. Digestive stability and acute toxicity studies of exogenous protein in transgenic rice expressing lysine-rich fusion proteins. Chin. Sci. Bull. 58, 2460–2468 (2013). https://doi.org/10.1007/s11434-013-5923-y
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11434-013-5923-y