TY - JOUR
T1 - Lack of adverse effects in subchronic and chronic toxicity/carcinogenicity studies on the glyphosate-resistant genetically modified maize NK603 in Wistar Han RCC rats
AU - Steinberg, Pablo
AU - van der Voet, Hilko
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
PY - 2019/4/1
Y1 - 2019/4/1
N2 - 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.
AB - 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.
KW - Biosafety
KW - Combined chronic toxicity/carcinogenicity study
KW - G-TwYST
KW - Genetically modified maize NK603
KW - GMO risk assessment
KW - OECD Test Guideline No. 408
KW - OECD Test Guideline No. 453
KW - Rat feeding trial
KW - Subchronic oral toxicity study
UR - http://www.scopus.com/inward/record.url?scp=85061445008&partnerID=8YFLogxK
UR - https://graz.pure.elsevier.com/en/publications/lack-of-adverse-effects-in-subchronic-and-chronic-toxicitycarcinogenicity-studies-on-the-glyphosateresistant-genetically-modified-maize-nk603-in-wistar-han-rcc-rats(7c645123-f50f-4b77-ab2a-103e7941fe12).html
U2 - 10.1007/s00204-019-02400-1
DO - 10.1007/s00204-019-02400-1
M3 - Article
C2 - 30756133
SN - 0340-5761
VL - 93
SP - 1095
EP - 1139
JO - Archives of Toxicology
JF - Archives of Toxicology
IS - 4
ER -