Séralini Gilles-Eric, Cellier Dominique, de Vendomois Joël Spiroux
Committee for Independent Information and Research on Genetic Engineering CRIIGEN, Paris, France.
Arch Environ Contam Toxicol. 2007 May;52(4):596-602. doi: 10.1007/s00244-006-0149-5. Epub 2007 Mar 13.
Health risk assessment of genetically modified organisms (GMOs) cultivated for food or feed is under debate throughout the world, and very little data have been published on mid- or long-term toxicological studies with mammals. One of these studies performed under the responsibility of Monsanto Company with a transgenic corn MON863 has been subjected to questions from regulatory reviewers in Europe, where it was finally approved in 2005. This necessitated a new assessment of kidney pathological findings, and the results remained controversial. An Appeal Court action in Germany (Münster) allowed public access in June 2005 to all the crude data from this 90-day rat-feeding study. We independently re-analyzed these data. Appropriate statistics were added, such as a multivariate analysis of the growth curves, and for biochemical parameters comparisons between GMO-treated rats and the controls fed with an equivalent normal diet, and separately with six reference diets with different compositions. We observed that after the consumption of MON863, rats showed slight but dose-related significant variations in growth for both sexes, resulting in 3.3% decrease in weight for males and 3.7% increase for females. Chemistry measurements reveal signs of hepatorenal toxicity, marked also by differential sensitivities in males and females. Triglycerides increased by 24-40% in females (either at week 14, dose 11% or at week 5, dose 33%, respectively); urine phosphorus and sodium excretions diminished in males by 31-35% (week 14, dose 33%) for the most important results significantly linked to the treatment in comparison to seven diets tested. Longer experiments are essential in order to indicate the real nature and extent of the possible pathology; with the present data it cannot be concluded that GM corn MON863 is a safe product.
用于食品或饲料的转基因生物（GMO）的健康风险评估在全球范围内都存在争议，关于哺乳动物中长期毒理学研究的公开数据非常少。孟山都公司负责开展的一项针对转基因玉米MON863的此类研究受到了欧洲监管评审人员的质疑，该研究最终于2005年在欧洲获批。这就需要对肾脏病理结果进行重新评估，而结果仍存在争议。2005年6月，德国（明斯特）的一家上诉法院采取行动，使得公众能够获取这项为期90天的大鼠喂养研究的所有原始数据。我们独立重新分析了这些数据。添加了适当的统计分析，比如对生长曲线进行多变量分析，以及比较转基因处理大鼠与食用等量正常饮食对照组之间的生化参数，还分别与六种不同成分的参考饮食进行了比较。我们观察到，食用MON863后，大鼠的生长出现了轻微但与剂量相关的显著变化，雄性体重下降了3.3%，雌性体重增加了3.7%。化学测量结果显示出肝肾毒性迹象，雄性和雌性的敏感性也存在差异。雌性甘油三酯分别在第14周剂量为11%时或第5周剂量为33%时增加了24% - 40%；与七种测试饮食相比，雄性尿液中磷和钠的排泄量在第14周剂量为33%时减少了31% - 35%，这些是与处理显著相关的最重要结果。为了明确可能病理状况的真实性质和程度，进行更长时间的实验至关重要；根据目前的数据，无法得出转基因玉米MON863是安全产品的结论。
