G-TwYST study A combined chronic toxicity and carcinogenicity study in rats fed GM maize NK603 : statistical report, 3 months data

Goedhart, P.W.; Voet, Hilko van der

doi:10.18174/455206

Cited by 4 publications

(1 citation statement)

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“…Statistical analysis of the G-TwYST studies was reported in Study A: Goedhart & van der Voet (2018a, 2018b2018c, 2018d Study B: Goedhart & van der Voet (2017) Study C: Goedhart & van der Voet (2018f) Note that for Study A there are separate reports for data acquired after 3, 6, 12 and 24 months as well as a main report. Study B and C were 3 months studies only.…”

Section: Introductionmentioning

confidence: 99%

Statistical analysis of differential white blood cell counts for G-TwYST studies A and C

Goedhart

Voet

2018

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Section: Introductionmentioning

confidence: 99%

Statistical analysis of differential white blood cell counts for G-TwYST studies A and C

Goedhart

Voet

2018

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Lack of adverse effects in subchronic and chronic toxicity/carcinogenicity studies on the glyphosate-resistant genetically modified maize NK603 in Wistar Han RCC rats

et al. 2019

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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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G-TwYST study A combined chronic toxicity and carcinogenicity study in rats fed GM maize NK603 : statistical report, 3 months data

Abstract: Male 247 102 1 Female 251 99-uBil Missing 0 Male 251 99 Female 251 99 P-values smaller than 0.01/0.05 have a gold/yellow background.

Cited by 4 publications

References 2 publications

Statistical analysis of differential white blood cell counts for G-TwYST studies A and C

Statistical analysis of differential white blood cell counts for G-TwYST studies A and C

Lack of adverse effects in subchronic and chronic toxicity/carcinogenicity studies on the glyphosate-resistant genetically modified maize NK603 in Wistar Han RCC rats

G-TwYST harmonisation of statistical methods for use of omics data in food safety assessment

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