title: One-year oral toxicity study on a genetically modified maize MON810 variety in Wistar Han RCC rats (EU 7th Framework Programme project GRACE).
abstract: 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.
authors.affiliation: Faculty of Public Health, Slovak Medical University in Bratislava, Limbová 12, 83303, Bratislava, Slovakia.
authors.forename: Dagmar
authors.initials: D
authors.lastname: Zeljenková
authors.affiliation: Faculty of Public Health, Slovak Medical University in Bratislava, Limbová 12, 83303, Bratislava, Slovakia.
authors.forename: Radka
authors.initials: R
authors.lastname: Aláčová
authors.affiliation: Faculty of Public Health, Slovak Medical University in Bratislava, Limbová 12, 83303, Bratislava, Slovakia.
authors.forename: Júlia
authors.initials: J
authors.lastname: Ondrejková
authors.affiliation: Faculty of Public Health, Slovak Medical University in Bratislava, Limbová 12, 83303, Bratislava, Slovakia.
authors.forename: Katarína
authors.initials: K
authors.lastname: Ambrušová
authors.affiliation: Faculty of Public Health, Slovak Medical University in Bratislava, Limbová 12, 83303, Bratislava, Slovakia.
authors.forename: Mária
authors.initials: M
authors.lastname: Bartušová
authors.affiliation: Faculty of Public Health, Slovak Medical University in Bratislava, Limbová 12, 83303, Bratislava, Slovakia.
authors.forename: Anton
authors.initials: A
authors.lastname: Kebis
authors.affiliation: Faculty of Public Health, Slovak Medical University in Bratislava, Limbová 12, 83303, Bratislava, Slovakia.
authors.forename: Jevgenij
authors.initials: J
authors.lastname: Kovrižnych
authors.affiliation: Faculty of Public Health, Slovak Medical University in Bratislava, Limbová 12, 83303, Bratislava, Slovakia.
authors.forename: Eva
authors.initials: E
authors.lastname: Rollerová
authors.affiliation: Faculty of Public Health, Slovak Medical University in Bratislava, Limbová 12, 83303, Bratislava, Slovakia.
authors.forename: Elena
authors.initials: E
authors.lastname: Szabová
authors.affiliation: Faculty of Public Health, Slovak Medical University in Bratislava, Limbová 12, 83303, Bratislava, Slovakia.
authors.forename: Soňa
authors.initials: S
authors.lastname: Wimmerová
authors.affiliation: Faculty of Medicine, Slovak Medical University in Bratislava, Limbová 12, 83303, Bratislava, Slovakia.
authors.forename: Martin
authors.initials: M
authors.lastname: Černák
authors.affiliation: Faculty of Medicine, Slovak Medical University in Bratislava, Limbová 12, 83303, Bratislava, Slovakia.
authors.forename: Zora
authors.initials: Z
authors.lastname: Krivošíková
authors.affiliation: Faculty of Medicine, Slovak Medical University in Bratislava, Limbová 12, 83303, Bratislava, Slovakia.
authors.forename: Miroslava
authors.initials: M
authors.lastname: Kuricová
authors.affiliation: Faculty of Medicine, Slovak Medical University in Bratislava, Limbová 12, 83303, Bratislava, Slovakia.
authors.forename: Aurélia
authors.initials: A
authors.lastname: Líšková
authors.affiliation: Faculty of Medicine, Slovak Medical University in Bratislava, Limbová 12, 83303, Bratislava, Slovakia.
authors.forename: Viera
authors.initials: V
authors.lastname: Spustová
authors.affiliation: Faculty of Medicine, Slovak Medical University in Bratislava, Limbová 12, 83303, Bratislava, Slovakia.
authors.forename: Jana
authors.initials: J
authors.lastname: Tulinská
authors.affiliation: University of Veterinary Medicine and Pharmacy in Košice and TOPALAB, Kamenicna 7, 01015, Košice, Slovakia.
authors.forename: Mikuláš
authors.initials: M
authors.lastname: Levkut
authors.affiliation: University of Veterinary Medicine and Pharmacy in Košice and TOPALAB, Kamenicna 7, 01015, Košice, Slovakia.
authors.forename: Viera
authors.initials: V
authors.lastname: Révajová
authors.affiliation: University of Veterinary Medicine and Pharmacy in Košice and TOPALAB, Kamenicna 7, 01015, Košice, Slovakia.
authors.forename: Zuzana
authors.initials: Z
authors.lastname: Ševčíková
authors.affiliation: BioMath GmbH, Schnickmannstr. 4, 18055, Rostock, Germany.
authors.forename: Kerstin
authors.initials: K
authors.lastname: Schmidt
authors.affiliation: BioMath GmbH, Schnickmannstr. 4, 18055, Rostock, Germany.
authors.forename: Jörg
authors.initials: J
authors.lastname: Schmidtke
authors.affiliation: BioMath GmbH, Schnickmannstr. 4, 18055, Rostock, Germany.
authors.forename: Paul
authors.initials: P
authors.lastname: Schmidt
authors.affiliation: Centre for Research in Agricultural Genomics (CRAG), Edifici CRAG, Campus UAB, 08193, Cerdanyola, Barcelona, Spain.
authors.forename: Jose Luis
authors.initials: JL
authors.lastname: La Paz
authors.affiliation: Centre for Research in Agricultural Genomics (CRAG), Edifici CRAG, Campus UAB, 08193, Cerdanyola, Barcelona, Spain.
authors.forename: Maria
authors.initials: M
authors.lastname: Corujo
authors.affiliation: Universitat de Girona (UDG), Edifici EPS1, Campus Montilivi, 17071, Girona, Spain.
authors.forename: Maria
authors.initials: M
authors.lastname: Pla
authors.affiliation: RIKILT Wageningen UR, Wageningen University and Research Centre, Akkermaalsbos 2, 6708WB, Wageningen, The Netherlands.
authors.forename: Gijs A
authors.initials: GA
authors.lastname: Kleter
authors.affiliation: RIKILT Wageningen UR, Wageningen University and Research Centre, Akkermaalsbos 2, 6708WB, Wageningen, The Netherlands.
authors.forename: Esther J
authors.initials: EJ
authors.lastname: Kok
authors.affiliation: Institute of Veterinary Biochemistry, Freie Universität Berlin, Oertzenweg 19b, 14163, Berlin, Germany.
authors.forename: Jutta
authors.initials: J
authors.lastname: Sharbati
authors.affiliation: Institute of Veterinary Biochemistry, Freie Universität Berlin, Oertzenweg 19b, 14163, Berlin, Germany.
authors.forename: Marc
authors.initials: M
authors.lastname: Bohmer
authors.affiliation: Institute of Veterinary Biochemistry, Freie Universität Berlin, Oertzenweg 19b, 14163, Berlin, Germany.
authors.forename: Nils
authors.initials: N
authors.lastname: Bohmer
authors.affiliation: Institute of Veterinary Biochemistry, Freie Universität Berlin, Oertzenweg 19b, 14163, Berlin, Germany.
authors.forename: Ralf
authors.initials: R
authors.lastname: Einspanier
authors.affiliation: INRA, UR496 Immuno-Allergie Alimentaire, CEA/IBiTeC-S/SPI, CEA de Saclay, 91191, Gif Sur Yvette Cedex, France.
authors.forename: Karine
authors.initials: K
authors.lastname: Adel-Patient
authors.affiliation: IFZ-Inter-University Research Centre for Technology, Work and Culture (IFZ), Schlögelgasse 2, 8010, Graz, Austria.
authors.forename: Armin
authors.initials: A
authors.lastname: Spök
authors.affiliation: Federal Institute for Risk Assessment, Max-Dohrn-Straße 8-10, 10589, Berlin, Germany.
authors.forename: Annette
authors.initials: A
authors.lastname: Pöting
authors.affiliation: Institute for Biosafety in Plant Biotechnology, Julius Kühn-Institut, Federal Research Centre for Cultivated Plants, Erwin-Baur-Str. 27, 06484, Quedlinburg, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Kohl
authors.affiliation: Institute for Biosafety in Plant Biotechnology, Julius Kühn-Institut, Federal Research Centre for Cultivated Plants, Erwin-Baur-Str. 27, 06484, Quedlinburg, Germany.
authors.forename: Ralf
authors.initials: R
authors.lastname: Wilhelm
authors.affiliation: Institute for Biosafety in Plant Biotechnology, Julius Kühn-Institut, Federal Research Centre for Cultivated Plants, Erwin-Baur-Str. 27, 06484, Quedlinburg, Germany.
authors.forename: Joachim
authors.initials: J
authors.lastname: Schiemann
authors.affiliation: Institute for Food Toxicology and Analytical Chemistry, University of Veterinary Medicine Hannover, Bischofsholer Damm 15, 30173, Hannover, Germany. pablo.steinberg@tiho-hannover.de.
authors.forename: Pablo
authors.initials: P
authors.lastname: Steinberg
mesh_terms: D000821:Animal Feed / Q000592:standards / Q000633:toxicity; D000818:Animals; D005260:Female; D030841:Food, Genetically Modified / Q000633:toxicity*; D006304:Health Status; D008297:Male; D030821:Plants, Genetically Modified / Q000633:toxicity*; D011919:Rats, Inbred Strains; D018570:Risk Assessment; D036401:Toxicity Tests, Chronic; D003313:Zea mays / Q000235:genetics*
keywords: Chronic oral toxicity study; Food/Feed Guidance Document of the EFSA Scientific Committee (2011); GRACE; Genetically modified maize MON810; OECD Test Guideline No. 452–Chronic toxicity studies (2009); Rat feeding trial