One-year oral toxicity study on a genetically modified maize MON810 variety in Wistar Han RCC rats (EU 7th Framework Programme project GRACE)

Dagmar Zeljenková, Radka Aláčová, Júlia Ondrejková, Katarína Ambrušová, Mária Bartušová, Anton Kebis, Jevgenij Kovrižnych, Eva Rollerová, Elena Szabová, Soňa Wimmerová, Martin Černák, Zora Krivošíková, Miroslava Kuricová, Aurélia Líšková, Viera Spustová, Jana Tulinská, Mikuláš Levkut, Viera Révajová, Zuzana Ševčíková, Kerstin Schmidt, Jörg Schmidtke, Paul Schmidt, Jose Luis La Paz, Maria Corujo, Maria Pla, Gijs A. Kleter, Esther J. Kok, Jutta Sharbati, Marc Bohmer, Nils Bohmer, Ralf Einspanier, Karine Adel-Patient, Armin Spök, Annette Pöting, Christian Kohl, Ralf Wilhelm, Joachim Schiemann, Pablo Steinberg

The GRACE (GMO Risk Assessment and Communication of Evidence; www.grace-fp7.eu ) project was funded by the European Commission within the 7th Framework Programme. A key objective of GRACE was 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 a 1-year feeding trial with a GM maize MON810 variety, its near-isogenic non-GM comparator and an additional conventional maize variety 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 452. 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 a chronic exposure.