1. Lack of adverse effects in subchronic and chronic toxicity/ carcinogenicity studies on the glyphosate-resistant genetically modified maize NK603 in Wistar Han RCC rats
- Author
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Júlia Babincová, Soňa Jaďuďová, Gijs Kleter, Wolfgang Baumgärtner, Dagmar Zeljenková, Hilko van der Voet, Anton Kebis, Roger Alison, Dieter Schrenk, Zora Krivošíková, Armin Spök, Jana Tulinska, Ralf Wilhelm, Monica Racovita, Paul W. Goedhart, Aurelia Liskova, Elena Szabova, Esther J. Kok, Huib de Vriend, Eva Rollerova, Radka Aláčová, Miroslava Lehotska Mikusova, Charlotte Lempp, Kathrin Becker, Pablo Steinberg, Anna Nadal, Melinda Takácsová, Maria Pla, Marion Schmicke, Joachim Schiemann, Clare Alison, A. Pöting, and European Commission
- Subjects
0301 basic medicine ,Male ,Health, Toxicology and Mutagenesis ,G-TwYST ,Food, Genetically Modified ,Drug Resistance ,Physiology ,Genetically modified crops ,OECD Test Guideline No. 453 ,010501 environmental sciences ,Toxicology ,01 natural sciences ,chemistry.chemical_compound ,Rat feeding trial ,Medicine ,Biosafety ,Toxicity Tests, Chronic ,Chronic toxicity ,Blat de moro -- Genètica ,2. Zero hunger ,OECD Test Guideline No. 408 ,BU Toxicology ,General Medicine ,Plants, Genetically Modified ,3. Good health ,Genetically modified organism ,Enginyeria genètica vegetal ,Biometris ,Glyphosate ,Genetically modified maize NK603 ,Toxicity ,Female ,BU Toxicology, Novel Foods & Agro chains Sub A ,Novel Foods & Agro chains Sub A ,Plant genetic engineering ,Drug-Related Side Effects and Adverse Reactions ,Carcinogenicity Tests ,Glycine ,GMO risk assessment ,Subchronic oral toxicity study ,Zea mays ,03 medical and health sciences ,Corn -- Genetics ,Animals ,Rats, Wistar ,Adverse effect ,Carcinogen ,0105 earth and related environmental sciences ,Genetically modified maize ,Combined chronic toxicity/carcinogenicity study ,Plantes transgèniques ,business.industry ,Herbicides ,Toxicity Tests, Subchronic ,Transgenic plants ,Correction ,Animal Feed ,030104 developmental biology ,chemistry ,business - 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., This study was carried out as part of the G-TwYST project (“GM Plant Two Year Safety Testing”), financially supported by the Seventh Framework Programme of the European Community for Research, Technological Development and Demonstration Activities (FP7), Grant Agreement No. 632165.
- Published
- 2019