Transgenic Research

, Volume 25, Issue 2, pp 163–172 | Cite as

Safety assessment of lepidopteran insect-protected transgenic rice with cry2A* gene

  • Shiying Zou
  • Kunlun Huang
  • Wentao Xu
  • Yunbo Luo
  • Xiaoyun HeEmail author
Original Paper


Numerous genetically modified (GM) crops expressing proteins for insect resistance have been commercialized following extensive testing demonstrating that the foods obtained from them are as safe as that obtained from their corresponding non-GM varieties. In this paper, we report the outcome of safety studies conducted on a newly developed insect-resistant GM rice expressing the cry2A* gene by a subchronic oral toxicity study on rats. GM rice and non-GM rice were incorporated into the diet at levels of 30, 50, and 70 % (w/w), No treatment-related adverse or toxic effects were observed based on an examination of the daily clinical signs, body weight, food consumption, hematology, serum biochemistry, and organ weight or based on gross and histopathological examination. These results demonstrate that the GM rice with cry2A* gene is as safe for food as conventional non-GM rice.


Genetically modified rice Cry2A* gene Safety assessment 90-Day feeding study 



Bacillus thuringiensis


Genetically modified


World Health Organization


European Union


Organization for Economic Cooperation and Development


One-way analysis of variance


Environmental Protection Agency



The authors thank Prof. Yongjun Lin of Hua Zhong Agricultural University for providing the GM rice with cry2A* gene for the study. The work was supported by the National GMO Cultivation Major Project of New Varieties (2011ZX08011-005 and 2014ZX08011-005).

Compliance with ethical standards

Conflict of interest

The authors declare no conflict of interest.

Supplementary material

11248_2015_9920_MOESM1_ESM.tif (43 kb)
Supplementary material 1 (TIFF 42 kb)
11248_2015_9920_MOESM2_ESM.docx (19 kb)
Supplementary material 2 (DOCX 18 kb)


  1. Barton KA, Whiteley HR, Yang NS (1987) Bacillus thuringiensis section sign-endotoxin expressed in transgenic Nicotiana tabacum provides resistance to lepidopteran insects. Plant Physiol 85:1103–1109PubMedCentralCrossRefPubMedGoogle Scholar
  2. Betz FS, Hammond BG, Fuchs RL (2000) Safety and advantages of Bacillus thuringiensis-protected plants to control insect pests. Regul Toxicol Pharmacol 32:156–173CrossRefPubMedGoogle Scholar
  3. Cao S, He X, Xu W, Luo Y, Yuan Y, Liu P, Cao B, Shi H, Huang K (2012) Safety assessment of transgenic Bacillus thuringiensis rice T1c-19 in Sprague–Dawley rats from metabonomics and bacterial profile perspectives. IUBMB Life 64:242–250CrossRefPubMedGoogle Scholar
  4. Chen H, Tang W, Xu C, Li X, Lin Y, Zhang Q (2005) Transgenic indica rice plants harboring a synthetic cry2A* gene of Bacillus thuringiensis exhibit enhanced resistance against lepidopteran rice pests. Theor Appl Genet 111:1330–1337CrossRefPubMedGoogle Scholar
  5. Cohen M, Gould F, Bentur J (2000) Bt rice: practical steps to sustainable use. Int Rice Res Notes 25:4–10Google Scholar
  6. Estruch JJ, Carozzi NB, Desai N, Duck NB, Warren GW, Koziel MG (1997) Transgenic plants: an emerging approach to pest control. Nat Biotechnol 15:137–141CrossRefPubMedGoogle Scholar
  7. Karim S, Dean DH (2000) Toxicity and receptor binding properties of Bacillus thuringiensis delta-endotoxins to the midgut brush border membrane vesicles of the rice leaf folders, Cnaphalocrocis medinalis and Marasmia patnalis. Curr Microbiol 41:276–283CrossRefPubMedGoogle Scholar
  8. Kuiper HA, Kleter GA, Noteborn HP, Kok EJ (2001) Assessment of the food safety issues related to genetically modified foods. Plant J 27:503–528CrossRefPubMedGoogle Scholar
  9. Larkin P, Harrigan GG (2007) Opportunities and surprises in crops modified by transgenic technology: metabolic engineering of benzylisoquinoline alkaloid, gossypol and lysine biosynthetic pathways. Metabolomics 3:371–382CrossRefGoogle Scholar
  10. Manimaran P, Ramkumar G, Mohan M, Mangrauthia SK, Padmakumari AP, Muthuraman P, Bentur JS, Viraktamath BC, Balachandran SM (2011) Bt rice evaluation and deployment strategies. GM Crops 2:135–137CrossRefPubMedGoogle Scholar
  11. Matteson PC (2000) Insect pest management in tropical Asian irrigated rice. Annu Rev Entomol 45:549–574CrossRefPubMedGoogle Scholar
  12. Mendelsohn M, Kough J, Vaituzis Z, Matthews K (2003) Are Bt crops safe? Nat Biotechnol 21:1003–1009CrossRefPubMedGoogle Scholar
  13. OECD (1993a) Safety evaluation of foods derived by modern biotechnology. Organisation for Economic Cooperation and Development, Paris.
  14. OECD (1996) Food safety evaluation. Organisation for Economic Corporation and Development, ParisGoogle Scholar
  15. OECD (1998) Report of the OECD workshop on the toxicological and nutritional testing of novel foods, Aussois, France, 5–8 March 1997. Organisation for Economic Cooperation and Development, Paris.
  16. Oerke E-C, Dehne H-W, Schönbeck F, Weber A (2012) Crop production and crop protection: estimated losses in major food and cash crops. Elsevier, AmsterdamGoogle Scholar
  17. Qi X, He X, Luo Y, Li S, Zou S, Cao S, Tang M, Delaney B, Xu W, Huang K (2012) Subchronic feeding study of stacked trait genetically-modified soybean (3O5423 x 40-3-2) in Sprague–Dawley rats. Food Chem Toxicol 50:3256–3263CrossRefPubMedGoogle Scholar
  18. Reeves PG, Rossow KL, Lindlauf J (1993) Development and testing of the AIN-93 purified diets for rodents: results on growth, kidney calcification and bone mineralization in rats and mice. J Nutr 123:1923–1931PubMedGoogle Scholar
  19. Seck PA, Diagne A, Mohanty S, Wopereis MC (2012) Crops that feed the world 7: rice. Food Secur 4:7–24CrossRefGoogle Scholar
  20. Tyagi AK, Mohanty A (2000) Rice transformation for crop improvement and functional genomics. Plant Sci 158:1–18CrossRefPubMedGoogle Scholar
  21. Wang Z, Wang Y, Cui H, Xia Y, Altosaar I, Shu Q (2002) Toxicological evaluation of transgenic rice flour with a synthetic cry1Ab gene from Bacillus thuringiensis. J Sci Food Agric 82:738–744CrossRefGoogle Scholar
  22. Wang EH, Yu Z, Hu J, Jia XD, Xu HB (2014) A two-generation reproduction study with transgenic Bt rice TT51 in Wistar rats. Food Chem Toxicol 65:312–320CrossRefPubMedGoogle Scholar
  23. Yoshikawa Y, Kishimoto Y, Tagami H, Kanahori S (2013) Assessment of the safety of hydrogenated resistant maltodextrin: reverse mutation assay, acute and 90-day subchronic repeated oral toxicity in rats, and acute no-effect level for diarrhea in humans. J Toxicol Sci 38:459–470CrossRefPubMedGoogle Scholar
  24. Yuan Y, Xu W, He X, Liu H, Cao S, Qi X, Huang K, Luo Y (2013) Effects of genetically modified T2A-1 rice on the GI health of rats after 90-day supplement. Sci Rep 3:1962PubMedCentralPubMedGoogle Scholar
  25. Zhang M, Zhuo Q, Tian Y, Piao J, Yang X (2014) Long-term toxicity study on transgenic rice with Cry1Ac and sck genes. Food Chem Toxicol 63:76–83CrossRefPubMedGoogle Scholar
  26. Zhu Y, He X, Luo Y, Zou S, Zhou X, Huang K, Xu W (2013) A 90-day feeding study of glyphosate-tolerant maize with the G2-aroA gene in Sprague–Dawley rats. Food Chem Toxicol 51:280–287CrossRefPubMedGoogle Scholar
  27. Zou S, He X, Liu Y, Chen D, Luo Y, Huang K, Zhang W, Xu W (2014) Toxicological evaluation of lactase derived from recombinant Pichia pastoris. PLoS One 9:e106470PubMedCentralCrossRefPubMedGoogle Scholar

Copyright information

© Springer International Publishing Switzerland 2015

Authors and Affiliations

  • Shiying Zou
    • 1
    • 2
  • Kunlun Huang
    • 1
    • 2
    • 3
  • Wentao Xu
    • 1
    • 2
    • 3
  • Yunbo Luo
    • 1
    • 2
  • Xiaoyun He
    • 1
    • 2
    • 3
    Email author
  1. 1.College of Food Science and Nutritional EngineeringChina Agricultural UniversityBeijingChina
  2. 2.The Supervision, Inspection and Testing Center for Genetically Modified OrganismsMinistry of AgricultureBeijingChina
  3. 3.Beijing Laboratory of Food Quality and SafetyBeijingChina

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