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

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

doi:10.1007/s00204-014-1374-8

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

Dagmar Zeljenková, Katarína Ambrušová, Mária Bartušová, Anton Kebis, Jevgenij Kovrižnych, Zora Krivošíková, Miroslava Kuricová, Aurélia Líšková, Eva Rollerová, Viera Spustová, Elena Szabová, Jana Tulinská, Soňa Wimmerová, Mikuláš Levkut, Viera Révajová, Zuzana Ševčíková, Kerstin Schmidt, Jörg Schmidtke, Jose Luis La Paz, Maria CorujoMaria Pla, Gijs A. Kleter, Esther J. Kok, Jutta Sharbati, Carlos Hanisch, Ralf Einspanier, Karine Adel-Patient, Jean Michel Wal, Armin Spök, Annette Pöting, Christian Kohl, Ralf Wilhelm, Joachim Schiemann, Pablo Steinberg^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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.

Original language	English
Pages (from-to)	2289-2314
Number of pages	26
Journal	Archives of Toxicology
Volume	88
Issue number	12
DOIs	https://doi.org/10.1007/s00204-014-1374-8
Publication status	Published - 29 Nov 2014

Keywords

Food/Feed Guidance Document of the EFSA Scientific Committee (2011)
Genetically modified maize MON810
GRACE
Rat feeding trial
Subchronic oral toxicity study

ASJC Scopus subject areas

Toxicology
Health, Toxicology and Mutagenesis

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Zeljenková, D., Ambrušová, K., Bartušová, M., Kebis, A., Kovrižnych, J., Krivošíková, Z., Kuricová, M., Líšková, A., Rollerová, E., Spustová, V., Szabová, E., Tulinská, J., Wimmerová, S., Levkut, M., Révajová, V., Ševčíková, Z., Schmidt, K., Schmidtke, J., La Paz, J. L., ... Steinberg, P. (2014). Ninety-day oral toxicity studies on two genetically modified maize MON810 varieties in Wistar Han RCC rats (EU 7th Framework Programme project GRACE). Archives of Toxicology, 88(12), 2289-2314. https://doi.org/10.1007/s00204-014-1374-8

Zeljenková, D, Ambrušová, K, Bartušová, M, Kebis, A, Kovrižnych, J, Krivošíková, Z, Kuricová, M, Líšková, A, Rollerová, E, Spustová, V, Szabová, E, Tulinská, J, Wimmerová, S, Levkut, M, Révajová, V, Ševčíková, Z, Schmidt, K, Schmidtke, J, La Paz, JL, Corujo, M, Pla, M, Kleter, GA, Kok, EJ, Sharbati, J, Hanisch, C, Einspanier, R, Adel-Patient, K, Wal, JM, Spök, A, Pöting, A, Kohl, C, Wilhelm, R, Schiemann, J & Steinberg, P 2014, 'Ninety-day oral toxicity studies on two genetically modified maize MON810 varieties in Wistar Han RCC rats (EU 7th Framework Programme project GRACE)', Archives of Toxicology, vol. 88, no. 12, pp. 2289-2314. https://doi.org/10.1007/s00204-014-1374-8

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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.",

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AU - Zeljenková, Dagmar

AU - Ambrušová, Katarína

AU - Bartušová, Mária

AU - Kebis, Anton

AU - Kovrižnych, Jevgenij

AU - Krivošíková, Zora

AU - Kuricová, Miroslava

AU - Líšková, Aurélia

AU - Rollerová, Eva

AU - Spustová, Viera

AU - Szabová, Elena

AU - Tulinská, Jana

AU - Wimmerová, Soňa

AU - Levkut, Mikuláš

AU - Révajová, Viera

AU - Ševčíková, Zuzana

AU - Schmidt, Kerstin

AU - Schmidtke, Jörg

AU - La Paz, Jose Luis

AU - Corujo, Maria

AU - Pla, Maria

AU - Kleter, Gijs A.

AU - Kok, Esther J.

AU - Sharbati, Jutta

AU - Hanisch, Carlos

AU - Einspanier, Ralf

AU - Adel-Patient, Karine

AU - Wal, Jean Michel

AU - Spök, Armin

AU - Pöting, Annette

AU - Kohl, Christian

AU - Wilhelm, Ralf

AU - Schiemann, Joachim

AU - Steinberg, Pablo

PY - 2014/11/29

Y1 - 2014/11/29

N2 - 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.

AB - 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.

KW - Food/Feed Guidance Document of the EFSA Scientific Committee (2011)

KW - Genetically modified maize MON810

KW - GRACE

KW - Rat feeding trial

KW - Subchronic oral toxicity study

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ER -

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

Abstract

Keywords

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