title: A 90-day toxicology study of transgenic lysine-rich maize grain (Y642) in Sprague-Dawley rats.
abstract: The gene for a lysine-rich protein (sb401) obtained from potatoes (Solanum berthaultii) was inserted into maize seed to produce Y642 transgenic maize. Compositional analysis of Y642 grain demonstrated that the concentrations of lysine and total protein were higher than those observed in maize grain from a near-isogenic non-genetically modified (non-GM) commercially available control quality protein maize (Nongda 108). The safety of Y642 maize grain was assessed by comparison of toxicology response variables in Sprague-Dawley (SD) rats consuming diets containing Y642 maize grain with those containing Nongda 108 maize grain. Maize grains from Y642 or Nongda 108 were incorporated into rodent diets at low (30%) or high concentrations (76%) and administered to SD rats (n=10/sex/group) for 90 days. An additional group of negative control group of rats (n=10/sex/group) were fed AIN93G diets. No adverse diet-related differences in body weights, feed consumption/utilization, clinical chemistry, hematology, absolute and relative organ weights were observed. Further, no differences in gross or microscopic pathology were observed between rats consuming diets with Y642 maize grain compared with rats consuming diets containing Nongda 108 maize grain. These results demonstrated that Y642 lysine-rich maize is as safe and nutritious as conventional quality protein maize.
authors.affiliation: College of Food Science and Nutritional Engineering, China Agricultural University, No. 17 Tsinghua Donglu, Beijing 100083, China.
authors.forename: Xiao Yun
authors.initials: XY
authors.lastname: He
authors.forename: Mao Zhi
authors.initials: MZ
authors.lastname: Tang
authors.forename: Yun Bo
authors.initials: YB
authors.lastname: Luo
authors.forename: Xin
authors.initials: X
authors.lastname: Li
authors.forename: Si Shuo
authors.initials: SS
authors.lastname: Cao
authors.forename: Jing Juan
authors.initials: JJ
authors.lastname: Yu
authors.forename: Bryan
authors.initials: B
authors.lastname: Delaney
authors.forename: Kun Lun
authors.initials: KL
authors.lastname: Huang
mesh_terms: D000818:Animals; D001835:Body Weight / Q000187:drug effects; D019963:Clinical Chemistry Tests; D004435:Eating / Q000187:drug effects; D005260:Female; D006403:Hematologic Tests; D008136:Longevity / Q000187:drug effects; D008239:Lysine / Q000235:genetics / Q000378:metabolism / Q000633:toxicity*; D008297:Male; D009929:Organ Size / Q000187:drug effects; D014674:Plant Proteins, Dietary / Q000235:genetics / Q000378:metabolism / Q000633:toxicity*; D030821:Plants, Genetically Modified / Q000235:genetics / Q000378:metabolism / Q000633:toxicity*; D051381:Rats; D017207:Rats, Sprague-Dawley; D018675:Toxicity Tests; D003313:Zea mays / Q000235:genetics / Q000378:metabolism / Q000633:toxicity*
chemical_list: D014674:Plant Proteins, Dietary; D008239:Lysine