NDLI: Variability of control data and relevance of observed group differences in five oral toxicity studies with genetically modified maize MON810 in rats

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Variability of control data and relevance of observed group differences in five oral toxicity studies with genetically modified maize MON810 in rats

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Variability of control data and relevance of observed group differences in five oral toxicity studies with genetically modified maize MON810 in rats

Content Provider	Springer Nature Link
Author	Schmidt, Kerstin Schmidtke, Jörg Schmidt, Paul Kohl, Christian Wilhelm, Ralf Schiemann, Joachim Voet, Hilko Steinberg, Pablo
Copyright Year	2016
Abstract	The data of four 90-day feeding trials and a 1-year feeding trial with the genetically modified (GM) maize MON810 in Wistar Han RCC rats performed in the frame of EU–funded project GRACE were analysed. Firstly, the data obtained from the groups having been fed the non–GM maize diets were combined to establish a historical control data set for Wistar Han RCC rats at the animal housing facility (Slovak Medical University, Bratislava, Slovakia). The variability of all parameters is described, and the reference values and ranges have been derived. Secondly, the consistency of statistically significant differences found in the five studies was analysed. In order to do so, the body weight development, organ weight, haematology and clinical biochemistry data were compared between the studies. Based on the historical control data, equivalence ranges for these parameters were defined, and the values measured in the GM maize–fed groups were compared with these equivalence ranges. Thirdly, the (statistical) power of these feeding studies with whole food/feed was assessed and detectable toxicologically relevant group differences were derived. Linear mixed models (LMM) were applied, and standardized effect sizes (SES) were calculated in order to compare different parameters as well as to provide an overall picture of group and study differences at a glance. The comparison of the five feeding trials showed a clear study effect in the control data. It also showed inconsistency both in the frequency of statistically significant differences and in the difference values between control and test groups.
Starting Page	1977
Ending Page	2006
Page Count	30
File Format	PDF
ISSN	03405761
Journal	Archives of Toxicology
Volume Number	91
Issue Number	4
e-ISSN	14320738
Language	English
Publisher	Springer Berlin Heidelberg
Publisher Date	2016-10-11
Publisher Place	Berlin, Heidelberg
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	90-day toxicity study Genetically modified plants Maize Risk assessment Historical control data Linear mixed models Standardized effect sizes Statistical power Consistency Pharmacology/Toxicology Occupational Medicine/Industrial Medicine Environmental Health Biomedicine
Content Type	Text
Resource Type	Article
Subject	Health, Toxicology and Mutagenesis Medicine Toxicology

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