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Genetic and rat toxicity studies of cyclodextrin glucanotransferase

INTRODUCTION: Microbiologically derived cyclodextrin glucanotransferase (CGTase) is used commercially as a processing agent in manufacture of food, pharmaceuticals, and cosmetics. Its toxic potential was evaluated in anticipation of use in the production of alpha-glycosyl isoquercitrin, a water-solu...

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Autores principales: Maronpot, Robert R., Hobbs, Cheryl A., Davis, Jeffrey, Swartz, Carol, Boyle, Molly, Koyanagi, Mihoko, Hayashi, Shim-mo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5615836/
https://www.ncbi.nlm.nih.gov/pubmed/28959560
http://dx.doi.org/10.1016/j.toxrep.2016.03.002
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author Maronpot, Robert R.
Hobbs, Cheryl A.
Davis, Jeffrey
Swartz, Carol
Boyle, Molly
Koyanagi, Mihoko
Hayashi, Shim-mo
author_facet Maronpot, Robert R.
Hobbs, Cheryl A.
Davis, Jeffrey
Swartz, Carol
Boyle, Molly
Koyanagi, Mihoko
Hayashi, Shim-mo
author_sort Maronpot, Robert R.
collection PubMed
description INTRODUCTION: Microbiologically derived cyclodextrin glucanotransferase (CGTase) is used commercially as a processing agent in manufacture of food, pharmaceuticals, and cosmetics. Its toxic potential was evaluated in anticipation of use in the production of alpha-glycosyl isoquercitrin, a water-soluble form of quercetin. METHODS: Following OECD guidelines, CGTase, produced by Bacillus pseudalcaliphilus DK-1139, was evaluated in a genotoxicity battery consisting of a bacterial reverse mutation assay, an in vitro micronucleus (MN) assay and MN and comet assays using B6C3F1 male and female mice. These same genotoxicity assays were also conducted for sodium sulfate, a contaminant of CGTase preparation. In a 90-day Sprague Dawley rat toxicity study, CGTase was administered by gavage in water at daily doses of 0, 250, 500, and 1000 mg/kg/day. RESULTS: CGTase did not induce mutations with or without metabolic activation in the bacterial reverse mutation assay. Formation of micronuclei was not induced in either in vitro or in vivo MN assays with or without metabolic activation. No induction of DNA damage was detected in male or female mouse liver, stomach, or duodenum in the comet assay. Sodium sulfate also tested negative in these same genotoxicity assays. In the 90-day repeated dose rat study there were no treatment-related adverse clinical or pathological findings. CONCLUSION: The genotoxicity assays and repeated dose toxicity study support the safe use of CGTase in production of alpha-glycosyl isoquercitrin.
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spelling pubmed-56158362017-09-28 Genetic and rat toxicity studies of cyclodextrin glucanotransferase Maronpot, Robert R. Hobbs, Cheryl A. Davis, Jeffrey Swartz, Carol Boyle, Molly Koyanagi, Mihoko Hayashi, Shim-mo Toxicol Rep Article INTRODUCTION: Microbiologically derived cyclodextrin glucanotransferase (CGTase) is used commercially as a processing agent in manufacture of food, pharmaceuticals, and cosmetics. Its toxic potential was evaluated in anticipation of use in the production of alpha-glycosyl isoquercitrin, a water-soluble form of quercetin. METHODS: Following OECD guidelines, CGTase, produced by Bacillus pseudalcaliphilus DK-1139, was evaluated in a genotoxicity battery consisting of a bacterial reverse mutation assay, an in vitro micronucleus (MN) assay and MN and comet assays using B6C3F1 male and female mice. These same genotoxicity assays were also conducted for sodium sulfate, a contaminant of CGTase preparation. In a 90-day Sprague Dawley rat toxicity study, CGTase was administered by gavage in water at daily doses of 0, 250, 500, and 1000 mg/kg/day. RESULTS: CGTase did not induce mutations with or without metabolic activation in the bacterial reverse mutation assay. Formation of micronuclei was not induced in either in vitro or in vivo MN assays with or without metabolic activation. No induction of DNA damage was detected in male or female mouse liver, stomach, or duodenum in the comet assay. Sodium sulfate also tested negative in these same genotoxicity assays. In the 90-day repeated dose rat study there were no treatment-related adverse clinical or pathological findings. CONCLUSION: The genotoxicity assays and repeated dose toxicity study support the safe use of CGTase in production of alpha-glycosyl isoquercitrin. Elsevier 2016-03-07 /pmc/articles/PMC5615836/ /pubmed/28959560 http://dx.doi.org/10.1016/j.toxrep.2016.03.002 Text en © 2016 The Authors http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Article
Maronpot, Robert R.
Hobbs, Cheryl A.
Davis, Jeffrey
Swartz, Carol
Boyle, Molly
Koyanagi, Mihoko
Hayashi, Shim-mo
Genetic and rat toxicity studies of cyclodextrin glucanotransferase
title Genetic and rat toxicity studies of cyclodextrin glucanotransferase
title_full Genetic and rat toxicity studies of cyclodextrin glucanotransferase
title_fullStr Genetic and rat toxicity studies of cyclodextrin glucanotransferase
title_full_unstemmed Genetic and rat toxicity studies of cyclodextrin glucanotransferase
title_short Genetic and rat toxicity studies of cyclodextrin glucanotransferase
title_sort genetic and rat toxicity studies of cyclodextrin glucanotransferase
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5615836/
https://www.ncbi.nlm.nih.gov/pubmed/28959560
http://dx.doi.org/10.1016/j.toxrep.2016.03.002
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