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 SpökMonica 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 journalArticlepeer-review


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
Issue number4
Early online date12 Feb 2019
Publication statusPublished - 1 Apr 2019


  • 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


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