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 (University of Veterinary Medicine Hannover, Institute for Food Toxicology (Germany))
van der Voet, Hilko (Wageningen University and Research. Biometris (The Netherlands))
Goedhart, Paul W. (Wageningen University and Research. Biometris (The Netherlands))
Kleter, Gijs (RIKILT Wageningen University & Research (The Netherlands))
Kok, Esther J. (RIKILT Wageningen University & Research (The Netherlands))
Pla, Maria (Centre de Recerca en Agrigenòmica)
Nadal, Anna (Universitat de Girona. Institut de Tecnologia Agroalimentària)
Zeljenková, Dagmar. (Slovak Medical University (Slovakia))
Aláčová, Radka (Slovak Medical University (Slovakia))
Babincová, Júlia (Slovak Medical University (Slovakia))
Rollerová, Eva (Slovak Medical University (Slovakia))
Jaďuďová, Soňa (Slovak Medical University (Slovakia))
Kebis, Anton (Slovak Medical University (Slovakia))
Szabová, Elena (Slovak Medical University (Slovakia))
Tulinská, Jana (Slovak Medical University (Slovakia))
Líšková, Aurélia (Slovak Medical University (Slovakia))
Takácsová, Melinda (Slovak Medical University (Slovakia))
Mikušová, Miroslava Lehotská (Slovak Medical University (Slovakia))
Krivošíková, Zora (Slovak Medical University (Slovakia))
Spök, Armin (Alpen-Adria Universität Klagenfurt (Austria))
Racovita, Monica (Alpen-Adria Universität Klagenfurt (Austria))
de Vriend, Huib (LIS Consult (The Netherlands))
Alison, Roger (Roger Alison Ltd. (UK))
Alison, Clare (Roger Alison Ltd. (UK))
Baumgärtner, Wolfgang (University of Veterinary Medicine Hannover. Department of Pathology (Germany))
Becker, Kathrin (University of Veterinary Medicine Hannover. Department of Pathology (Germany))
Lempp, Charlotte (University of Veterinary Medicine Hannover. Department of Pathology (Germany))
Schmicke, Marion (University of Veterinary Medicine Hannover. Clinic for Cattle (Germany))
Schrenk, Dieter (University of Kaiserslautern. Food Chemistry and Toxicology (Germany))
Pöting, Annette (Federal Institute for Risk Assessment (Germany))
Schiemann, Joachim (Julius Kühn-Institut. Institute for Biosafety in Plant Biotechnology. Federal Research Centre for Cultivated Plants (Germany))
Wilhelm, Ralf (Julius Kühn-Institut. Institute for Biosafety in Plant Biotechnology. Federal Research Centre for Cultivated Plants (Germany))

Data:	2019
Resum:	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.
Ajuts:	European Commission 632165
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Genetically modified maize NK603 ; GMO risk assessment ; Biosafety ; G-TwYST ; OECD Test Guideline No. 408 ; OECD Test Guideline No. 453 ; Rat feeding trial ; Subchronic oral toxicity study ; Combined chronic toxicity/carcinogenicity study
Publicat a:	Archives of Toxicology, Vol. 93 (February 2019) , p. 1095-1139, ISSN 1432-0738

DOI: 10.1007/s00204-019-02400-1
PMID: 30756133

45 p, 10.5 MB

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