title: Ninety-day oral toxicity studies on two genetically modified maize MON810 varieties in Wistar Han RCC rats (EU 7th Framework Programme project GRACE).
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.
authors.affiliation: Slovak Medical University, Limbová 12, 83303, Bratislava, Slovakia.
authors.forename: Dagmar
authors.initials: D
authors.lastname: Zeljenková
authors.forename: Katarína
authors.initials: K
authors.lastname: Ambrušová
authors.forename: Mária
authors.initials: M
authors.lastname: Bartušová
authors.forename: Anton
authors.initials: A
authors.lastname: Kebis
authors.forename: Jevgenij
authors.initials: J
authors.lastname: Kovrižnych
authors.forename: Zora
authors.initials: Z
authors.lastname: Krivošíková
authors.forename: Miroslava
authors.initials: M
authors.lastname: Kuricová
authors.forename: Aurélia
authors.initials: A
authors.lastname: Líšková
authors.forename: Eva
authors.initials: E
authors.lastname: Rollerová
authors.forename: Viera
authors.initials: V
authors.lastname: Spustová
authors.forename: Elena
authors.initials: E
authors.lastname: Szabová
authors.forename: Jana
authors.initials: J
authors.lastname: Tulinská
authors.forename: Soňa
authors.initials: S
authors.lastname: Wimmerová
authors.forename: Mikuláš
authors.initials: M
authors.lastname: Levkut
authors.forename: Viera
authors.initials: V
authors.lastname: Révajová
authors.forename: Zuzana
authors.initials: Z
authors.lastname: Ševčíková
authors.forename: Kerstin
authors.initials: K
authors.lastname: Schmidt
authors.forename: Jörg
authors.initials: J
authors.lastname: Schmidtke
authors.forename: Jose Luis
authors.initials: JL
authors.lastname: La Paz
authors.forename: Maria
authors.initials: M
authors.lastname: Corujo
authors.forename: Maria
authors.initials: M
authors.lastname: Pla
authors.forename: Gijs A
authors.initials: GA
authors.lastname: Kleter
authors.forename: Esther J
authors.initials: EJ
authors.lastname: Kok
authors.forename: Jutta
authors.initials: J
authors.lastname: Sharbati
authors.forename: Carlos
authors.initials: C
authors.lastname: Hanisch
authors.forename: Ralf
authors.initials: R
authors.lastname: Einspanier
authors.forename: Karine
authors.initials: K
authors.lastname: Adel-Patient
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Wal
authors.forename: Armin
authors.initials: A
authors.lastname: Spök
authors.forename: Annette
authors.initials: A
authors.lastname: Pöting
authors.forename: Christian
authors.initials: C
authors.lastname: Kohl
authors.forename: Ralf
authors.initials: R
authors.lastname: Wilhelm
authors.forename: Joachim
authors.initials: J
authors.lastname: Schiemann
authors.forename: Pablo
authors.initials: P
authors.lastname: Steinberg
mesh_terms: D000284:Administration, Oral; D000821:Animal Feed / Q000592:standards / Q000633:toxicity; D000818:Animals; D001835:Body Weight; D003257:Consumer Product Safety; D004032:Diet; D005260:Female; D030841:Food, Genetically Modified / Q000633:toxicity*; D008297:Male; D009929:Organ Size; D030821:Plants, Genetically Modified / Q000633:toxicity*; D011919:Rats, Inbred Strains; D012107:Research Design; D018570:Risk Assessment; D059550:Toxicity Tests, Subchronic; D003313:Zea mays / Q000235:genetics*