1. One-year oral toxicity study on a genetically modified maize MON810 variety in Wistar Han RCC rats (EU 7th Framework Programme project GRACE).
- Author
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Zeljenková D, Aláčová R, Ondrejková J, Ambrušová K, Bartušová M, Kebis A, Kovrižnych J, Rollerová E, Szabová E, Wimmerová S, Černák M, Krivošíková Z, Kuricová M, Líšková A, Spustová V, Tulinská J, Levkut M, Révajová V, Ševčíková Z, Schmidt K, Schmidtke J, Schmidt P, La Paz JL, Corujo M, Pla M, Kleter GA, Kok EJ, Sharbati J, Bohmer M, Bohmer N, Einspanier R, Adel-Patient K, Spök A, Pöting A, Kohl C, Wilhelm R, Schiemann J, and Steinberg P
- Subjects
- Animals, Female, Male, Rats, Inbred Strains, Risk Assessment, Toxicity Tests, Chronic, Animal Feed standards, Animal Feed toxicity, Food, Genetically Modified toxicity, Health Status, Plants, Genetically Modified toxicity, Zea mays genetics
- 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., Competing Interests: Compliance with ethical standardsConflict of interestKerstin Schmidt provides consulting services in the field of biostatistics and has advised National and European Authorities, biotech and pharmaceutical companies as well as research institutions, also in the context of GMO risk assessment. Pablo Steinberg is a member of the Scientific Board of the Institut Danone Ernährung für Gesundheit e.V. (Munich, Germany) and has co-authored three scientific papers sponsored by ILSI Europe.
- Published
- 2016
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