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
Voet, Hilto van der
Goedhart, Paul W.
Kleter, Gijs A.
Kok, Esther J.
Zeljenková, Dagmar
Aláčová, Radka
Babincová, Júlia
Rollerová, Eva
Jaďuďová, Soňa
Kebis, Anton
Szabová, Elena
Tulinská, Jana
Líšková, Aurélia
Takácsová, Melinda
Krivošíková, Zora
Spök, Armin
Racovita, Monica
Vriend, Huib de
Alison, Roger
Alison, Clare
Baumgärtner, Wolfgang
Becker, Kathrin
Lempp, Charlotte
Schmicke, Marion
Schrenk, Dieter
Pöting, Annette
Schiemann, Joachim
Wilhelm, Ralf
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 ​
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