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 Spök & 12 Sonstige Monica Racovita, Huib de Vriend, Roger Alison, Clare Alison, Wolfgang Baumgärtner, Kathrin Becker, Charlotte Lempp, Marion Schmicke, Dieter Schrenk, Annette Pöting, Joachim Schiemann, Ralf Wilhelm

Publikation: Beitrag in einer FachzeitschriftArtikelForschungBegutachtung

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.

Spracheenglisch
Seiten1095-1139
Seitenumfang45
FachzeitschriftArchives of Toxicology
Jahrgang93
Ausgabennummer4
Frühes Online-Datum12 Feb 2019
DOIs
StatusVeröffentlicht - 1 Apr 2019

Fingerprint

glyphosate
Zea mays
Toxicity
Rats
Genetically modified plants
Safety testing
Genetically Modified Plants
Laboratory Animals
Herbicides
Risk assessment
Animals
Guidelines
Safety
Food
Control Groups

Schlagwörter

    ASJC Scopus subject areas

    • !!Health, Toxicology and Mutagenesis
    • Toxikologie

    Fields of Expertise

    • Human- & Biotechnology

    Dies zitieren

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

    in: Archives of Toxicology, Jahrgang 93, Nr. 4, 01.04.2019, S. 1095-1139.

    Publikation: Beitrag in einer FachzeitschriftArtikelForschungBegutachtung

    Steinberg, P, van der Voet, H, Goedhart, PW, Kleter, G, Kok, EJ, Pla, M, Nadal, A, Zeljenková, D, Aláčová, R, Babincová, J, Rollerová, E, Jaďuďová, S, Kebis, A, Szabova, E, Tulinská, J, Líšková, A, Takácsová, M, Mikušová, ML, Krivošíková, Z, Spök, A, Racovita, M, de Vriend, H, Alison, R, Alison, C, Baumgärtner, W, Becker, K, Lempp, C, Schmicke, M, Schrenk, D, Pöting, A, Schiemann, J & Wilhelm, R 2019, 'Lack of adverse effects in subchronic and chronic toxicity/carcinogenicity studies on the glyphosate-resistant genetically modified maize NK603 in Wistar Han RCC rats', Archives of Toxicology, Jg. 93, Nr. 4, S. 1095-1139. https://doi.org/10.1007/s00204-019-02400-1
    Steinberg, Pablo ; van der Voet, Hilko ; Goedhart, Paul W ; Kleter, Gijs ; Kok, Esther J ; Pla, Maria ; Nadal, Anna ; Zeljenková, Dagmar ; Aláčová, Radka ; Babincová, Júlia ; Rollerová, Eva ; Jaďuďová, Soňa ; Kebis, Anton ; Szabova, Elena ; Tulinská, Jana ; Líšková, Aurélia ; Takácsová, Melinda ; Mikušová, Miroslava Lehotská ; Krivošíková, Zora ; Spök, Armin ; Racovita, Monica ; de Vriend, Huib ; Alison, Roger ; Alison, Clare ; Baumgärtner, Wolfgang ; Becker, Kathrin ; Lempp, Charlotte ; Schmicke, Marion ; Schrenk, Dieter ; Pöting, Annette ; Schiemann, Joachim ; Wilhelm, Ralf. / Lack of adverse effects in subchronic and chronic toxicity/carcinogenicity studies on the glyphosate-resistant genetically modified maize NK603 in Wistar Han RCC rats. in: Archives of Toxicology. 2019 ; Jahrgang 93, Nr. 4. S. 1095-1139.
    @article{7c645123f50f4b77ab2a103e7941fe12,
    title = "Lack of adverse effects in subchronic and chronic toxicity/carcinogenicity studies on the glyphosate-resistant genetically modified maize NK603 in Wistar Han RCC rats",
    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.",
    keywords = "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",
    author = "Pablo Steinberg and {van der Voet}, Hilko and Goedhart, {Paul W} and Gijs Kleter and Kok, {Esther J} and Maria Pla and Anna Nadal and Dagmar Zeljenkov{\'a} and Radka Al{\'a}čov{\'a} and J{\'u}lia Babincov{\'a} and Eva Rollerov{\'a} and Soňa Jaďuďov{\'a} and Anton Kebis and Elena Szabova and Jana Tulinsk{\'a} and Aur{\'e}lia L{\'i}škov{\'a} and Melinda Tak{\'a}csov{\'a} and Mikušov{\'a}, {Miroslava Lehotsk{\'a}} and Zora Krivoš{\'i}kov{\'a} and Armin Sp{\"o}k and Monica Racovita and {de Vriend}, Huib and Roger Alison and Clare Alison and Wolfgang Baumg{\"a}rtner and Kathrin Becker and Charlotte Lempp and Marion Schmicke and Dieter Schrenk and Annette P{\"o}ting and Joachim Schiemann and Ralf Wilhelm",
    year = "2019",
    month = "4",
    day = "1",
    doi = "10.1007/s00204-019-02400-1",
    language = "English",
    volume = "93",
    pages = "1095--1139",
    journal = "Archives of Toxicology",
    issn = "0340-5761",
    publisher = "Springer",
    number = "4",

    }

    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

    VL - 93

    SP - 1095

    EP - 1139

    JO - Archives of Toxicology

    T2 - Archives of Toxicology

    JF - Archives of Toxicology

    SN - 0340-5761

    IS - 4

    ER -