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

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