Safety evaluation of genetically modified DAS-40278-9 maize in a subchronic rodent feeding study

Regul Toxicol Pharmacol. 2018 Jul:96:146-152. doi: 10.1016/j.yrtph.2018.05.010. Epub 2018 May 17.

Abstract

Genetically modified (GM) maize, DAS-40278-9, expresses the aryloxyalkanoate dioxygenase-1 (AAD-1) protein, which confers tolerance to 2,4-dichlorophenoxyacetic acid (2,4-D) and aryloxyphenoxypropionate (AOPP) herbicides. The aad-1 gene, which expresses the AAD-1 protein, was derived from Gram-negative soil bacterium, Sphingobium herbicidovorans. A 90-day sub-chronic toxicity study was conducted on rats as a component of the safety evaluation of DAS-40278-9 maize. Rats were given formulated diets containing maize grain from DAS-40278-9 or a non-GM near isogenic control comparator at an incorporation rate of 12.5%, 25%, or 50% (w/w), respectively for 90 days. In addition, another group of rats was fed a basic rodent diet. Animals were evaluated by cage-side and hand-held detailed clinical observations, ophthalmic examinations, body weights/body weight gains, feed consumption, hematology, serum chemistry, selected organ weights, and gross and histopathological examinations. Under the condition of this study, DAS-40278-9 maize did not cause any treatment-related effects in rats compared with rats fed diets containing non-GM maize.

Keywords: 90-Day feeding study; Genetically modified; Herbicide tolerance; Maize; Safety assessment.

MeSH terms

  • Animal Feed / analysis*
  • Animals
  • Female
  • Male
  • Plants, Genetically Modified / adverse effects*
  • Plants, Genetically Modified / chemistry
  • Plants, Genetically Modified / genetics*
  • Rats
  • Rats, Sprague-Dawley
  • Zea mays / chemistry
  • Zea mays / genetics*