Dataset Information

Humoral and cellular immune response in Wistar Han RCC rats fed two genetically modified maize MON810 varieties for 90 days (EU 7th Framework Programme project GRACE).

ABSTRACT: The genetically modified maize event MON810 expresses a Bacillus thuringiensis-derived gene, which encodes the insecticidal protein Cry1Ab to control some lepidopteran insect pests such as the European corn borer. It has been claimed that the immune system may be affected following the oral/intragastric administration of the MON810 maize in various different animal species. In the frame of the EU-funded project GRACE, two 90-day feeding trials, the so-called studies D and E, were performed to analyze the humoral and cellular immune responses of male and female Wistar Han RCC rats fed the MON810 maize. A MON810 maize variety of Monsanto was used in the study D and a MON810 maize variety of Pioneer Hi-Bred was used in the study E. The total as well as the maize protein- and Cry1Ab-serum-specific IgG, IgM, IgA and IgE levels, the proliferative activity of the lymphocytes, the phagocytic activity of the granulocytes and monocytes, the respiratory burst of the phagocytes, a phenotypic analysis of spleen, thymus and lymph node cells as well as the in vitro production of cytokines by spleen cells were analyzed. No specific Cry1Ab immune response was observed in MON810 rats, and anti-maize protein antibody responses were similar in MON810 and control rats. Single parameters were sporadically altered in rats fed the MON810 maize when compared to control rats, but these alterations are considered to be of no immunotoxicological significance.

SUBMITTER: Tulinska J

PROVIDER: S-EPMC6015625 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Humoral and cellular immune response in Wistar Han RCC rats fed two genetically modified maize MON810 varieties for 90 days (EU 7th Framework Programme project GRACE).

Tulinská Jana J Adel-Patient Karine K Bernard Hervé H Líšková Aurélia A Kuricová Miroslava M Ilavská Silvia S Horváthová Mira M Kebis Anton A Rollerová Eva E Babincová Júlia J Aláčová Radka R Wal Jean-Michel JM Schmidt Kerstin K Schmidtke Jörg J Schmidt Paul P Kohl Christian C Wilhelm Ralf R Schiemann Joachim J Steinberg Pablo P

Archives of toxicology 20180531 7

The genetically modified maize event MON810 expresses a Bacillus thuringiensis-derived gene, which encodes the insecticidal protein Cry1Ab to control some lepidopteran insect pests such as the European corn borer. It has been claimed that the immune system may be affected following the oral/intragastric administration of the MON810 maize in various different animal species. In the frame of the EU-funded project GRACE, two 90-day feeding trials, the so-called studies D and E, were performed to an ...[more]

PMID: 29855658

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Project description:Background: Global as well as specific expression profiles of selected rat tissues were characterized to assess the safety of genetically modified (GM) maize MON810 containing the insecticidal protein Cry1Ab. Gene expression was evaluated by use of Next Generation Sequencing (NGS) as well as RT-qPCR within rat intestinal tissues based on mandatory 90-day rodent feeding studies. In parallel to two 90-day feeding studies, the transcriptional response of rat tissues was assessed as another endpoint to enhance the mechanistic interpretation of GM feeding studies and/or to facilitate the generation of a targeted hypothesis. Rats received diets containing 33% GM maize (MON810) or near-isogenic control maize. As a site of massive exposure to ingested feed the transcriptomic response of ileal and colonic tissue was profiled via RT-qPCR arrays targeting apoptosis, DNA-damage/repair, unfolded protein response (UPR). For global RNA profiling of rat ileal tissue, we applied NGS. Results: No biological response to the GM-diet was observed in male and in female rat tissues. Transcriptome wide analysis of gene expression by RNA-seq confirmed these findings. Nevertheless, gene ontology (GO) analysis clearly associated a set of distinctly regulated transcripts with circadian rhythms. We confirmed differential expression of circadian clock genes using RT-qPCR and immunoassays for selected factors, thereby indicating physiological effects caused by the time point of sampling. Conclusion: Prediction of potential unintended effects of GM-food/feed by transcriptome based profiling of intestinal tissue presents a novel approach to complement classical toxicological testing procedures. Including the detection of alterations in signaling pathways in toxicity testing procedures may enhance the confidence in outcomes of toxicological trials. In this study, no significant GM-related changes in intestinal expression profiles were found in rats fed GM-maize MON810. Relevant alterations of selected cellular pathways (apoptosis, DNA damage and repair, UPR) pointing toward intestinal toxicity of the diets were not observed. Transcriptomic profiles did not reveal perturbations of pathways associated with toxicity, underlining the study results revealed by classical OECD endpoints.

Project description:BackgroundTotal ankle replacement (TAR) utilization in the United States has steeply increased in recent decades. Emergency department (ED) visits following TAR impacts patient satisfaction and health care costs and warrant exploration.MethodsThis retrospective cohort study utilized the 2010 to 2019 M91Ortho PearlDiver data set to identify TAR patients with at least 90 days of follow-up. PearlDiver contains billing claims data across all sites of care throughout the United States for all indications for care. Patient factors extracted included age, sex, Elixhauser Comorbidity Index (ECI), region of the country in which surgery was performed, insurance plan, and postoperative hospital length of stay. Ninety-day postoperative ED visit incidence, timing, frequency, and primary diagnoses were identified and compared to 1-year postoperative ED visit baseline data. Univariate and multivariate logistic regression analyses were used to determine risk factors for ED visits.ResultsOf 5930 TAR patients identified, ED visits within 90 days were noted for 497 (8.4%) patients. Of all ED visits, 32.0% occurred within 2 weeks following surgery. Multivariate analysis revealed several predictors of ED utilization: younger age (odds ratio [OR] 1.35 per decade decrease), female sex (OR 1.20), higher ECI (OR 1.32 per 2-point increase), TAR performed in the western US (OR 1.34), and Medicaid coverage (OR 2.70; 1.71-4.22 relative to Medicare) (P < .05 each). Surgical site issues comprised 78.0% of ED visits, with surgical site pain (57.0%) as the most common problem.ConclusionOf 5930 TAR patients, 8.4% returned to the ED within 90 days of surgery, with predisposing demographic factors identified. The highest incidence of ED visits was in the first 2 postoperative weeks, and surgical site pain was the most common reason. Pain management pathways following TAR should be able to be adjusted to minimize the occurrence of postoperative ED visits, thereby improving patient experiences and decreasing health care utilization/costs.Level of evidenceLevel III, retrospective cohort study.

Project description:A genetically modified (GM) commercial corn variety, MON810, resistant to European corn borer, has been shown to be non-toxic to mammals in a number of rodent feeding studies carried out in accordance with OECD Guidelines. Insect resistance results from expression of the Cry1Ab gene encoding an insecticidal Bt protein that causes lysis and cell death in susceptible insect larvae by binding to midgut epithelial cells, which is a key determinant of Cry toxin species specificity. Whilst whole animal studies are still recognised as the 'gold standard' for safety assessment, they only provide indirect evidence for changes at the cellular/organ/tissue level. In contrast, omics-based technologies enable mechanistic understanding of toxicological or nutritional events at the cellular/receptor level. To address this important knowledge-gap and to gain insights into the underlying molecular responses in rat to MON810, differential gene expression in the epithelial cells of the small intestine of rats fed formulated diets containing MON810, its near isogenic line, two conventional corn varieties, and a commercial (Purina™) corn-based control diet were investigated using comparative proteomic profiling. Pairwise and five-way comparisons showed that the majority of proteins that were differentially expressed in the small intestine epithelial cells in response to consumption of the different diets in both 7-day and 28-day studies were related to lipid and carbohydrate metabolism and protein biosynthesis. Irrespective of the diet, a limited number of stress-related proteins were shown to be differentially expressed. However these stress-related proteins differed between diets. No adverse clinical or behavioural effects, or biomarkers of adverse health, were observed in rats fed GM corn compared to the other corn diets. These findings suggest that MON810 has negligible effects on the small intestine of rats at the cellular level compared with the well-documented toxicity observed in susceptible insects.

Dataset Information

Humoral and cellular immune response in Wistar Han RCC rats fed two genetically modified maize MON810 varieties for 90 days (EU 7th Framework Programme project GRACE).

Publications

Humoral and cellular immune response in Wistar Han RCC rats fed two genetically modified maize MON810 varieties for 90 days (EU 7th Framework Programme project GRACE).

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