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30% DAS-444Ø6-6 大豆粕在亚慢性大鼠毒性研究中的评价。

Evaluation of 30% DAS-444Ø6-6 soybean meal in a subchronic rat toxicity study.

机构信息

Dow AgroSciences LLC, Indianapolis, IN, 46268, USA.

Toxicology and Environmental Research and Consulting, The Dow Chemical Company, Midland, MI, 48674, USA.

出版信息

Regul Toxicol Pharmacol. 2018 Apr;94:57-69. doi: 10.1016/j.yrtph.2018.01.005. Epub 2018 Jan 6.

DOI:10.1016/j.yrtph.2018.01.005
PMID:29317244
Abstract

Event DAS-444Ø6-6 soybean is genetically modified (GM) to provide tolerance to 2,4-diclorophenoxyacetic acid (2,4-D), glyphosate, and glufosinate herbicides through expression of the AAD-12, 2mEPSPS, and PAT proteins, respectively. DAS-444Ø6-6 soybeans were evaluated for safety in subchronic rat feeding studies. The results from two previous subchronic rat feeding studies evaluating diets formulated with 20% inclusion of DAS-444Ø6-6 soybean meal (the latter also containing DAS-444Ø6-6 derived hulls and oil) did not show any treatment-related adverse effects. In 2017, to comply with recent guidance from EFSA, a third 90-day rat feeding study was conducted with Sprague-Dawley rats (16/sex/group) with diets formulated either with 15% or 30% w/w of toasted DAS-444Ø6-6 soybean meal. DAS-444Ø6-6 soybean hulls and oil were also added to the transgenic test diets at 1% or 2% w/w and 1.35% or 2.7%, respectively, for the low- and high-dose groups. No toxicologically significant effects were observed under the conditions of this study.

摘要

事件 DAS-444Ø6-6 大豆经过基因改良(GM),通过表达 AAD-12、2mEPSPS 和 PAT 蛋白,分别对 2,4-二氯苯氧乙酸(2,4-D)、草甘膦和草铵膦除草剂具有耐受性。DAS-444Ø6-6 大豆在亚慢性大鼠喂养研究中进行了安全性评估。之前两项评估含有 20% DAS-444Ø6-6 大豆粉的饲料配方的亚慢性大鼠喂养研究的结果[后者还含有 DAS-444Ø6-6 衍生的豆壳和油]没有显示出任何与处理相关的不良影响。2017 年,为了遵守 EFSA 的最新指南,用 Sprague-Dawley 大鼠(每组 16 只/性别)进行了第三次 90 天大鼠喂养研究,用 15%或 30% w/w 烤制的 DAS-444Ø6-6 大豆粉配制饲料。DAS-444Ø6-6 豆壳和油也分别以 1%或 2% w/w 和 1.35%或 2.7%的剂量添加到转基因测试饲料中,用于低剂量和高剂量组。在本研究条件下,未观察到具有毒理学意义的影响。

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