Lack of adverse effects in subchronic and chronic toxicity/carcinogenicity studies on the glyphosate-resistant genetically modified maize NK603 in Wistar Han RCC rats

Pablo Steinberg, Hilko van der Voet, Paul W Goedhart, Gijs Kleter, Esther J Kok, Maria Pla, Anna Nadal, Dagmar Zeljenková, Radka Aláčová, Júlia Babincová, Eva Rollerová, Soňa Jaďuďová, Anton Kebis, Elena Szabova, Jana Tulinská, Aurélia Líšková, Melinda Takácsová, Miroslava Lehotská Mikušová, Zora Krivošíková, Armin Spök & 12 others Monica Racovita, Huib de Vriend, Roger Alison, Clare Alison, Wolfgang Baumgärtner, Kathrin Becker, Charlotte Lempp, Marion Schmicke, Dieter Schrenk, Annette Pöting, Joachim Schiemann, Ralf Wilhelm

Research output: Contribution to journalArticleResearchpeer-review

Abstract

In 2012, a controversial study on the long-term toxicity of a Roundup herbicide and the glyphosate-tolerant genetically modified (GM) maize NK603 was published. The EC-funded G-TwYST research consortium tested the potential subchronic and chronic toxicity as well as the carcinogenicity of the glyphosate-resistant genetically modified maize NK603 by performing two 90-day feeding trials, one with GM maize inclusion rates of 11 and 33% and one with inclusion rates of up to 50%, as well as a 2-year feeding trial with inclusion rates of 11 and 33% in male and female Wistar Han RCC rats by taking into account OECD Guidelines for the testing of chemicals and EFSA recommendations on the safety testing of whole-food/feed in laboratory animals. In all three trials, the NK603 maize, untreated and treated once with Roundup during its cultivation, and the conventional counterpart were tested. Differences between each test group and the control group were evaluated. Equivalence was assessed by comparing the observed difference to differences between non-GM reference groups in previous studies. In case of significant differences, whether the effects were dose-related and/or accompanied by changes in related parameters including histopathological findings was evaluated. It is concluded that no adverse effects related to the feeding of the NK603 maize cultivated with or without Roundup for up to 2 years were observed. Based on the outcome of the subchronic and combined chronic toxicity/carcinogenicity studies, recommendations on the scientific justification and added value of long-term feeding trials in the GM plant risk assessment process are presented.

Original languageEnglish
Pages (from-to)1095-1139
Number of pages45
JournalArchives of Toxicology
Volume93
Issue number4
Early online date12 Feb 2019
DOIs
Publication statusPublished - 1 Apr 2019

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glyphosate
Zea mays
Toxicity
Rats
Genetically modified plants
Safety testing
Genetically Modified Plants
Laboratory Animals
Herbicides
Risk assessment
Animals
Guidelines
Safety
Food
Control Groups

Keywords

  • Biosafety
  • Combined chronic toxicity/carcinogenicity study
  • G-TwYST
  • Genetically modified maize NK603
  • GMO risk assessment
  • OECD Test Guideline No. 408
  • OECD Test Guideline No. 453
  • Rat feeding trial
  • Subchronic oral toxicity study

ASJC Scopus subject areas

  • Health, Toxicology and Mutagenesis
  • Toxicology

Fields of Expertise

  • Human- & Biotechnology

Cite this

Lack of adverse effects in subchronic and chronic toxicity/carcinogenicity studies on the glyphosate-resistant genetically modified maize NK603 in Wistar Han RCC rats. / Steinberg, Pablo; van der Voet, Hilko; Goedhart, Paul W; Kleter, Gijs; Kok, Esther J; Pla, Maria; Nadal, Anna; Zeljenková, Dagmar; Aláčová, Radka; Babincová, Júlia; Rollerová, Eva; Jaďuďová, Soňa; Kebis, Anton; Szabova, Elena; Tulinská, Jana; Líšková, Aurélia; Takácsová, Melinda; Mikušová, Miroslava Lehotská; Krivošíková, Zora; Spök, Armin; Racovita, Monica; de Vriend, Huib; Alison, Roger; Alison, Clare; Baumgärtner, Wolfgang; Becker, Kathrin; Lempp, Charlotte; Schmicke, Marion; Schrenk, Dieter; Pöting, Annette; Schiemann, Joachim; Wilhelm, Ralf.

In: Archives of Toxicology, Vol. 93, No. 4, 01.04.2019, p. 1095-1139.

Research output: Contribution to journalArticleResearchpeer-review

Steinberg, P, van der Voet, H, Goedhart, PW, Kleter, G, Kok, EJ, Pla, M, Nadal, A, Zeljenková, D, Aláčová, R, Babincová, J, Rollerová, E, Jaďuďová, S, Kebis, A, Szabova, E, Tulinská, J, Líšková, A, Takácsová, M, Mikušová, ML, Krivošíková, Z, Spök, A, Racovita, M, de Vriend, H, Alison, R, Alison, C, Baumgärtner, W, Becker, K, Lempp, C, Schmicke, M, Schrenk, D, Pöting, A, Schiemann, J & Wilhelm, R 2019, 'Lack of adverse effects in subchronic and chronic toxicity/carcinogenicity studies on the glyphosate-resistant genetically modified maize NK603 in Wistar Han RCC rats' Archives of Toxicology, vol. 93, no. 4, pp. 1095-1139. https://doi.org/10.1007/s00204-019-02400-1
Steinberg, Pablo ; van der Voet, Hilko ; Goedhart, Paul W ; Kleter, Gijs ; Kok, Esther J ; Pla, Maria ; Nadal, Anna ; Zeljenková, Dagmar ; Aláčová, Radka ; Babincová, Júlia ; Rollerová, Eva ; Jaďuďová, Soňa ; Kebis, Anton ; Szabova, Elena ; Tulinská, Jana ; Líšková, Aurélia ; Takácsová, Melinda ; Mikušová, Miroslava Lehotská ; Krivošíková, Zora ; Spök, Armin ; Racovita, Monica ; de Vriend, Huib ; Alison, Roger ; Alison, Clare ; Baumgärtner, Wolfgang ; Becker, Kathrin ; Lempp, Charlotte ; Schmicke, Marion ; Schrenk, Dieter ; Pöting, Annette ; Schiemann, Joachim ; Wilhelm, Ralf. / Lack of adverse effects in subchronic and chronic toxicity/carcinogenicity studies on the glyphosate-resistant genetically modified maize NK603 in Wistar Han RCC rats. In: Archives of Toxicology. 2019 ; Vol. 93, No. 4. pp. 1095-1139.
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AU - Goedhart, Paul W

AU - Kleter, Gijs

AU - Kok, Esther J

AU - Pla, Maria

AU - Nadal, Anna

AU - Zeljenková, Dagmar

AU - Aláčová, Radka

AU - Babincová, Júlia

AU - Rollerová, Eva

AU - Jaďuďová, Soňa

AU - Kebis, Anton

AU - Szabova, Elena

AU - Tulinská, Jana

AU - Líšková, Aurélia

AU - Takácsová, Melinda

AU - Mikušová, Miroslava Lehotská

AU - Krivošíková, Zora

AU - Spök, Armin

AU - Racovita, Monica

AU - de Vriend, Huib

AU - Alison, Roger

AU - Alison, Clare

AU - Baumgärtner, Wolfgang

AU - Becker, Kathrin

AU - Lempp, Charlotte

AU - Schmicke, Marion

AU - Schrenk, Dieter

AU - Pöting, Annette

AU - Schiemann, Joachim

AU - Wilhelm, Ralf

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KW - OECD Test Guideline No. 408

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