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

Author

Nils Bohmer, Zora Krivošíková, Esther J. Kok, Christian Kohl, Miroslava Kuricova, Maria Pla, Pablo Steinberg, Viera Spustova, Dagmar Zeljenková, Gijs Kleter, Zuzana Ševčíková, Elena Szabova, A. Pöting, Marc Bohmer, Anton Kebis, Armin Spök, Ralf Einspanier, Júlia Ondrejková, Maria Corujo, Soňa Wimmerová, Radka Aláčová, Martin Cernak, Ralf Wilhelm, Karine Adel-Patient, Mikuláš Levkut, Jana Tulinska, Joachim Schiemann, Kerstin Schmidt, Eva Rollerova, Katarína Ambrušová, Paul Schmidt, Jevgenij Kovrižnych, Jörg Schmidtke, Maria Bartusova, Jutta Sharbati, Jose Luis La Paz, Aurelia Liskova, Viera Revajová, Faculty of Public Health, Slovak Medical University of Bratislava (SMU), University of Veterinary Medicine and Pharmacy [Košice, Slovakia], GmbH, Center for Research in Agricultural Genomics, Universitat de Girona (UdG), Wageningen University and Research Centre (WUR), Free University of Berlin (FU), Service de Pharmacologie et d'Immunoanalyse (SPI), Institut National de la Recherche Agronomique (INRA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Université Paris-Saclay, Inter-University Research Centre on Technology, Work and Culture, Partenaires INRAE, Bundesinstitut für Risikobewertung - Federal Institute for Risk Assessment (BfR), Julius Kühn-Institut (JKI), University of Veterinary Medicine Hannover, Department of Animal Nutrition, EU, Service de Pharmacologie et Immunoanalyse (SPI), Médicaments et Technologies pour la Santé (MTS), Université Paris-Saclay-Direction de Recherche Fondamentale (CEA) (DRF (CEA)), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Paris-Saclay-Direction de Recherche Fondamentale (CEA) (DRF (CEA)), and Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)

Subjects
Male, 0301 basic medicine, Novel Foods & Agrochains, Health Status, Health, Toxicology and Mutagenesis, [SDV]Life Sciences [q-bio], Food, Genetically Modified, Genetically modified crops, Toxicology, Novel Foods & Agroketens, GRACE, Rat feeding trial, BU Toxicology, Novel Foods & Agrochains, Toxicity Tests, Chronic, Blat de moro -- Genètica, 2. Zero hunger, BU Toxicology, 04 agricultural and veterinary sciences, General Medicine, Plants, Genetically Modified, 040401 food science, Genetically modified organism, OECD Test Guideline No. 452-Chronic toxicity studies (2009), Enginyeria genètica vegetal, Food/Feed Guidance Document of the EFSA Scientific Committee (2011), BU Toxicologie, Novel Foods & Agroketens, Genetically modified maize MON810, OECD Test Guideline No. 452– Chronic toxicity studies (2009), Chronic oral toxicity study, Female, Risk assessment, Plant genetic engineering, Wistar Han, Animal feed, BU Toxicologie, Biologics, Biology, Risk Assessment, Zea mays, 03 medical and health sciences, Corn -- Genetics, 0404 agricultural biotechnology, OECD Test Guideline No. 452–Chronic toxicity studies (2009), Animals, Adverse effect, Genetically modified maize, Plantes transgèniques, business.industry, Transgenic plants, Rats, Inbred Strains, Guideline, Animal Feed, Biotechnology, 030104 developmental biology, business
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. Electronic supplementary material The online version of this article (doi:10.1007/s00204-016-1798-4) contains supplementary material, which is available to authorized users.

Published
2016
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4. Ninety-day oral toxicity studies on two genetically modified maize MON810 varieties in Wistar Han RCC rats (EU 7th Framework Programme project GRACE)

Author

Jutta Sharbati, Maria Corujo, Ralf Wilhelm, Katarína Ambrušová, Joachim Schiemann, Viera Spustova, Soňa Wimmerová, Eva Rollerova, Elena Szabova, Gijs Kleter, Anton Kebis, Viera Revajová, Aurelia Liskova, Jörg Schmidtke, Ralf Einspanier, Carlos Hanisch, Armin Spök, Jose Luis La Paz, A. Pöting, Jana Tulinska, Zora Krivošíková, Christian Kohl, Maria Pla, Maria Bartusova, Kerstin Schmidt, Jevgenij Kovrižnych, Zuzana Ševčíková, Esther J. Kok, Miroslava Kuricova, Pablo Steinberg, Karine Adel-Patient, Dagmar Zeljenková, Mikuláš Levkut, Jean-Michel Wal, European Commission, Ministry of Economic Affairs (The Netherlands), Slovak Medical University of Bratislava (SMU), GmbH, Universitat Autònoma de Barcelona (UAB), Universitat de Girona (UdG), RIKILT, Wageningen University and Research [Wageningen] (WUR), Free University of Berlin (FU), Unité de Recherche Immuno-Allergie Alimentaire, Institut National de la Recherche Agronomique (INRA), Alpen-Adria-Universität Klagenfurt [Klagenfurt, Austria], Bundesinstitut für Risikobewertung - Federal Institute for Risk Assessment (BfR), Julius Kühn-Institut (JKI), University of Veterinary Medicine Hannover, Department of Animal Nutrition, European Community [311957], and Dutch Ministry of Economic Affairs

Subjects
Male, genetically modified maize MON810, Health, Toxicology and Mutagenesis, [SDV]Life Sciences [q-bio], Food, Genetically Modified, Administration, Oral, Food/Feed Guidance Document of the EFSA Scientific Committee (2011), Genetically modified maize MON810, GRACE, Rat feeding trial, Subchronic oral toxicity study, Genetically modified crops, Toxicology, rat feeding trial, soybean trypsin-inhibitors, rat, Corn, Organ Size, General Medicine, Plants, Genetically Modified, Genetically modified organism, Research Design, Female, Risk assessment, maïs bt mon810, Wistar Han, Biology, Biologics, Risk Assessment, Zea mays, BU Authenticity & Bioassays, Animals, Oral toxicity, Adverse effect, Genetically modified maize, Plantes transgèniques, business.industry, Body Weight, Toxicity Tests, Subchronic, Transgenic plants, Rats, Inbred Strains, Animal Feed, proteins, quantification, Diet, Biotechnology, Blat de moro, bacillus-thuringiensis, BU Authenticiteit & Bioassays, Consumer Product Safety, Extended time, business, subchronic oral toxicity study
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., This study was carried out as part of the GRACE project (“GMO Risk Assessment and Communication of Evidence”), financially supported by the 7th Framework Programme of the European Community for Research, Technological Development and Demonstration Activities (FP7), Grant Agreement No. 311957, as well as the Dutch Ministry of Economic Affairs and various other co-sponsors.

Published
2014
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5. One‑year oral toxicity study on a genetically modified maize MON810 variety in Wistar Han RCC rats (EU 7th Framework Programme project GRACE)

Author

Kleter, G.A., Kok, E.J., Kleter, G.A., and Kok, E.J.

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.

Published
2016

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