Ninety-day oral toxicity studies on two genetically modified maize MON810 varieties in Wistar Han RCC rats (EU 7th Framework Programme project GRACE)

Dagmar Zeljenková, Katarína Ambrušová, Mária Bartušová, Anton Kebis, Jevgenij Kovrižnych, Zora Krivošíková, Miroslava Kuricová, Aurélia Líšková, Eva Rollerová, Viera Spustová, Elena Szabová, Jana Tulinská, Soňa Wimmerová, Mikuláš Levkut, Viera Révajová, Zuzana Ševčíková, Kerstin Schmidt, Jörg Schmidtke, Jose Luis La Paz, Maria Corujo & 14 others Maria Pla, Gijs A. Kleter, Esther J. Kok, Jutta Sharbati, Carlos Hanisch, Ralf Einspanier, Karine Adel-Patient, Jean Michel Wal, Armin Spök, Annette Pöting, Christian Kohl, Ralf Wilhelm, Joachim Schiemann, Pablo Steinberg

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    Abstract

    The GMO Risk Assessment and Communication of Evidence (GRACE; www.grace-fp7.eu) project is funded by the European Commission within the 7th Framework Programme. A key objective of GRACE is to conduct 90-day animal feeding trials, animal studies with an extended time frame as well as analytical, in vitro and in silico studies on genetically modified (GM) maize in order to comparatively evaluate their use in GM plant risk assessment. In the present study, the results of two 90-day feeding trials with two different GM maize MON810 varieties, their near-isogenic non-GM varieties and four additional conventional maize varieties are presented. The feeding trials were performed by taking into account the guidance for such studies published by the EFSA Scientific Committee in 2011 and the OECD Test Guideline 408. The results obtained show that the MON810 maize at a level of up to 33 % in the diet did not induce adverse effects in male and female Wistar Han RCC rats after subchronic exposure, independently of the two different genetic backgrounds of the event.

    Original languageEnglish
    Pages (from-to)2289-2314
    Number of pages26
    JournalArchives of Toxicology
    Volume88
    Issue number12
    DOIs
    Publication statusPublished - 29 Nov 2014

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    Keywords

    • Food/Feed Guidance Document of the EFSA Scientific Committee (2011)
    • Genetically modified maize MON810
    • GRACE
    • Rat feeding trial
    • Subchronic oral toxicity study

    ASJC Scopus subject areas

    • Toxicology
    • Health, Toxicology and Mutagenesis

    Cite this

    Zeljenková, D., Ambrušová, K., Bartušová, M., Kebis, A., Kovrižnych, J., Krivošíková, Z., ... Steinberg, P. (2014). Ninety-day oral toxicity studies on two genetically modified maize MON810 varieties in Wistar Han RCC rats (EU 7th Framework Programme project GRACE). Archives of Toxicology, 88(12), 2289-2314. https://doi.org/10.1007/s00204-014-1374-8