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Toxicological Study and Oxidative Stress Evaluation for Safety Assessment of Xylanase Preparations in Wistar Rats
Authors:Dorra Driss  Najla Soudani  Tahia Boudawara  Najiba Zeghal  Semia Ellouze Chaabouni
Institution:1. Unité Enzymes et Bioconversions, Ecole Nationale d’Ingénieurs de Sfax, University of Sfax, Sfax, Tunisia;2. Animal Physiology Laboratory, Life Sciences Department, Sfax Faculty of Sciences, University of Sfax, Sfax, Tunisia;3. Histopathology Laboratory, University of Sfax, Sfax, Tunisia;4. Unité de service Bioreacteur couplé à un Ultrafiltre, Ecole Nationale d’Ingénieurs de Sfax, University of Sfax, Sfax, Tunisia
Abstract:Acute and 90‐day subchronic oral toxicity studies were conducted to establish the safety evaluation of xylanases preparations. A potential oxidative stress evaluation was also performed through testing the generation of oxidative radicals, depletion of antioxidants via oxidative modification of lipids, proteins and DNA of organ cells. During the subchronic oral toxicity study, no mortality was observed, obvious treatment‐related clinical signs and urinalysis parameters were in normal range. Differences in some hematological parameters, biochemistry, relative organ weight, and histopathology examinations between the treated group and the control group were not judged to be adverse. Our results indicated that the no‐observed‐adverse‐effect level for xylanases was 1,500 TXU/kg/day and the plasma antioxidant assays showed that these xylanases did not produce free‐radicals nor oxidative injuries. On the basis of the bacterial reverse mutation assay data, it is concluded that the expressed xylanase in Pichia pastoris do not present any mutagenic potential when tested in relevant genotoxicological assays.
Keywords:Xylanase Preparations  Toxicological Assays  Antioxidant Enzyme Profiles  DNA Fragmentation  Histological Study  Bacterial Reverse Mutation
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