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

D Zeljenková; R Aláčová; J Ondrejková; K Ambrušová; M Bartušová; A Kebis; J Kovrižnych; E Rollerová; E Szabová; S Wimmerová; M Černák; Z Krivošíková; M Kuricová; A Líšková; V Spustová; J Tulinská; M Levkut; V Révajová; Z Ševčíková; Kerstin Schmidt; Jörg Schmidtke; Paul Schmidt; Jose Luis La Paz; Maria Corujo; Maria Pla; Gijs A. Kleter; Esther J Kok; Jutta Sharbati; Marc Bohmer; Nils Bohmer; Ralf Einspanier; Karine Adel-Patient; Armin Spoek; Annette Pöting; Christian Kohl; Ralf Wilhelm; Joachim Schiemann; Pablo Steinberg

doi:10.1007/s00204-016-1798-4

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

D Zeljenková, R Aláčová, J Ondrejková, K Ambrušová, M Bartušová, A Kebis, J Kovrižnych, E Rollerová, E Szabová, S Wimmerová, M Černák, Z Krivošíková, M Kuricová, A Líšková, V Spustová, J Tulinská, M Levkut, V Révajová, Z Ševčíková, Kerstin SchmidtJörg Schmidtke, Paul Schmidt, Jose Luis La Paz, Maria Corujo, Maria Pla, Gijs A. Kleter, Esther J Kok, Jutta Sharbati, Marc Bohmer, Nils Bohmer, Ralf Einspanier, Karine Adel-Patient, Armin Spoek, Annette Pöting, Christian Kohl, Ralf Wilhelm, Joachim Schiemann, Pablo Steinberg

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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.

Original language	English
Pages (from-to)	2531-2562
Journal	Archives of Toxicology
Volume	90
DOIs	https://doi.org/10.1007/s00204-016-1798-4
Publication status	Published - Oct 2016

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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., ... Steinberg, P. (2016). One-year oral toxicity study on a genetically modified maize MON810 variety in Wistar Han RCC rats (EU 7th Framework Programme project GRACE). Archives of Toxicology, 90, 2531-2562. https://doi.org/10.1007/s00204-016-1798-4

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, Spoek, A, Pöting, A, Kohl, C, Wilhelm, R, Schiemann, J & Steinberg, P 2016, 'One-year oral toxicity study on a genetically modified maize MON810 variety in Wistar Han RCC rats (EU 7th Framework Programme project GRACE).', Archives of Toxicology, vol. 90, pp. 2531-2562. https://doi.org/10.1007/s00204-016-1798-4

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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.",

author = "D Zeljenkov{\'a} and R Al{\'a}{\v c}ov{\'a} and J Ondrejkov{\'a} and K Ambru{\v s}ov{\'a} and M Bartu{\v s}ov{\'a} and A Kebis and J Kovri{\v z}nych and E Rollerov{\'a} and E Szabov{\'a} and S Wimmerov{\'a} and M {\v C}ern{\'a}k and Z Krivo{\v s}{\'i}kov{\'a} and M Kuricov{\'a} and A L{\'i}{\v s}kov{\'a} and V Spustov{\'a} and J Tulinsk{\'a} and M Levkut and V R{\'e}vajov{\'a} and Z {\v S}ev{\v c}{\'i}kov{\'a} and Kerstin Schmidt and J{\"o}rg Schmidtke and Paul Schmidt and {La Paz}, {Jose Luis} and Maria Corujo and Maria Pla and Kleter, {Gijs A.} and Kok, {Esther J} and Jutta Sharbati and Marc Bohmer and Nils Bohmer and Ralf Einspanier and Karine Adel-Patient and Armin Spoek and Annette P{\"o}ting and Christian Kohl and Ralf Wilhelm and Joachim Schiemann and Pablo Steinberg",

year = "2016",

month = oct,

doi = "10.1007/s00204-016-1798-4",

language = "English",

volume = "90",

pages = "2531--2562",

journal = "Archives of Toxicology",

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T1 - One-year oral toxicity study on a genetically modified maize MON810 variety in Wistar Han RCC rats (EU 7th Framework Programme project GRACE).

AU - Zeljenková, D

AU - Aláčová, R

AU - Ondrejková, J

AU - Ambrušová, K

AU - Bartušová, M

AU - Kebis, A

AU - Kovrižnych, J

AU - Rollerová, E

AU - Szabová, E

AU - Wimmerová, S

AU - Černák, M

AU - Krivošíková, Z

AU - Kuricová, M

AU - Líšková, A

AU - Spustová, V

AU - Tulinská, J

AU - Levkut, M

AU - Révajová, V

AU - Ševčíková, Z

AU - Schmidt, Kerstin

AU - Schmidtke, Jörg

AU - Schmidt, Paul

AU - La Paz, Jose Luis

AU - Corujo, Maria

AU - Pla, Maria

AU - Kleter, Gijs A.

AU - Kok, Esther J

AU - Sharbati, Jutta

AU - Bohmer, Marc

AU - Bohmer, Nils

AU - Einspanier, Ralf

AU - Adel-Patient, Karine

AU - Spoek, Armin

AU - Pöting, Annette

AU - Kohl, Christian

AU - Wilhelm, Ralf

AU - Schiemann, Joachim

AU - Steinberg, Pablo

PY - 2016/10

Y1 - 2016/10

N2 - 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.

AB - 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.

UR - http://europepmc.org/abstract/med/27439414

U2 - 10.1007/s00204-016-1798-4

DO - 10.1007/s00204-016-1798-4

M3 - Article

C2 - 27439414

SN - 0340-5761

VL - 90

SP - 2531

EP - 2562

JO - Archives of Toxicology

JF - Archives of Toxicology

ER -

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

Abstract

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