Corteva Agriscience, Johnston, IA, USA.
Corteva Agriscience, Johnston, IA, USA.
Food Chem Toxicol. 2024 Jul;189:114716. doi: 10.1016/j.fct.2024.114716. Epub 2024 May 11.
Several regulatory agencies continue to require animal feeding studies to approve new genetically modified crops despite such studies providing little value in the safety assessment. Feeding studies with maize grain containing event DP-915635-4 (DP915635), a new corn rootworm management trait, were conducted to fulfill that requirement. Diets fed to Crl:CD®(SD) rats for 90 days contained up to 50% ground maize grain from DP915635, non-transgenic control, or non-transgenic reference hybrids (P1197, 6158, and 6365). Ross 708 broilers received phase diets containing up to 67% maize grain from each source for 42 days. Growth performance was compared between animals fed DP915635 and control diets; rats were further evaluated for clinical and neurobehavioral measures, ophthalmology, clinical pathology, organ weights, and gross and microscopic pathology, whereas carcass parts and select organ yields were determined for broilers. Reference group inclusion assisted in determining natural variation influence on observed significant differences between DP915635 and control groups. DP915635 maize grain diet consumption did not affect any measure evaluated in either feeding study. Results demonstrated DP-915635-4 maize grain safety and nutritional equivalency when fed in nutritionally adequate diets, adding to the existing literature confirming the lack of significant effects of feeding grain from genetically modified plants.
尽管动物喂养研究在新转基因作物的安全性评估中提供的价值有限,但一些监管机构仍继续要求进行此类研究。为了满足这一要求,进行了含有 DP-915635-4(DP915635)事件的玉米籽粒的喂养研究,DP915635 是一种新的玉米根虫管理特性。用于喂养 Crl:CD®(SD)大鼠 90 天的饮食包含高达 50%的 DP915635、非转基因对照或非转基因参考杂交种(P1197、6158 和 6365)的玉米粉。罗斯 708 肉鸡接受了含有高达 67%来自每种来源的玉米粉的阶段饮食,为期 42 天。比较了喂食 DP915635 和对照饮食的动物之间的生长性能;对大鼠进行了临床和神经行为测量、眼科、临床病理学、器官重量以及大体和显微镜病理学的进一步评估,而肉鸡则确定了尸体部位和选定器官的产量。参考组的纳入有助于确定自然变异对 DP915635 和对照组之间观察到的显著差异的影响。在这两项喂养研究中,DP915635 玉米粉饮食的消耗都没有影响任何评估的指标。结果表明,在营养充足的饮食中食用 DP-915635-4 玉米籽粒是安全和营养等效的,这增加了现有文献,证实了食用转基因植物的谷物没有显著影响。