About: In vitro and in vivo safety evaluation of Nephure™

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An Entity of Type : schema:ScholarlyArticle, within Data Space : wasabi.inria.fr associated with source document(s)

Attributes	Values
type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	In vitro and in vivo safety evaluation of Nephure™
Creator	Cowley, Helena Dolan, Laurie Koetzner, Lee Nordwald, Erik Yan, Qin Cowley, Aaron
Source	Elsevier; Medline; PMC
abstract	Abstract Nephure™ is a proprietary oxalate decarboxylase (OxDC) enzyme being developed as a food ingredient. In this study, the safety of Nephure™ was evaluated in a bacterial mutagenicity assay and in a sub-chronic (13-week) oral toxicity study in rats. Nephure™ did not show any mutagenic properties in the mutagenicity assay. In the 13-week sub-chronic oral toxicity study in which 10 Sprague Dawley rats per sex were administered 0, 118, 235 and 475 mg/kg bw/day (8260, 16450 and 33,250 Units/kg bw/day, respectively) of Nephure™ by gavage, male and female rats did not show any test article-related clinical observations or effects on body weight, body weight gain, food consumption, food efficiency, ophthalmology, functional observational battery parameters or motor activity. Furthermore, there were no changes in coagulation, clinical chemistry, urinalysis or hematology parameters, macroscopic/microscopic findings or organ weights that could be attributed to the test article. Based on these results, Nephure™ was not mutagenic and the no-adverse-effect level (NOAEL) in the 13-week study was determined to be 475 mg/kg bw/day (33,250 Units/kg bw/day). Evaluation of the estimated consumption of Nephure™, generation of the metabolite formate, and the current safety studies resulted in a conclusion of a tolerable upper limit of 3450 Units of OxDC activity/day (57.5 Units activity/kg bw/day), when Nephure™ is added to food to decrease dietary oxalate.
has issue date	2017-06-30(xsd:dateTime)
bibo:doi	10.1016/j.yrtph.2017.03.016
bibo:pmid	28322893
has license	els-covid
sha1sum (hex)	98051953b3bd0b24f84d4ccbfa579130eacfe1d0
schema:url	https://doi.org/10.1016/j.yrtph.2017.03.016
resource representing a document's title	In vitro and in vivo safety evaluation of Nephure™
has PubMed Central identifier	PMC5500298
has PubMed identifier	28322893
schema:publication	Regulatory Toxicology and Pharmacology
resource representing a document's body	covid:98051953b3bd0b24f84d4ccbfa579130eacfe1d0#body_text
is schema:about of	named entity '475' named entity 'OBSERVATIONS' named entity 'ADMINISTERED' named entity 'CURRENT' named entity 'RATS' named entity '118' named entity 'SAFETY' named entity 'FOOD CONSUMPTION' named entity 'PARAMETERS' named entity 'URINALYSIS' named entity 'ORGAN WEIGHTS' named entity 'FOOD INGREDIENT' named entity 'RELATED' named entity 'RESULTS' named entity 'TO DECREASE' named entity 'SAFETY STUDIES' named entity 'TOLERABLE' named entity 'ARTICLE' named entity '2857' named entity 'SPRAGUE DAWLEY RATS' named entity 'MUTAGENIC' named entity 'BODY WEIGHT GAIN' named entity 'OBSERVATIONAL' named entity 'DIETARY' named entity 'CLINICAL CHEMISTRY' named entity 'ESTIMATED' named entity 'BODY WEIGHT' named entity 'COAGULATION' named entity 'STUDY' named entity 'PROPRIETARY' named entity 'EFFECTS' named entity 'CONSUMPTION' named entity 'ENZYME' named entity 'SUBCHRONIC' named entity 'OXALATE' named entity 'BACTERIAL' named entity 'FUNCTIONAL' named entity 'UNITS' named entity 'OPHTHALMOLOGY' named entity 'THESE' named entity 'BASED' named entity 'PROPERTIES' named entity 'HEMATOLOGY' named entity 'FORMATE' named entity 'ORAL TOXICITY' named entity 'EVALUATION' named entity 'SUB-' named entity 'DID' named entity 'EVALUATED' named entity 'EFFECT' named entity 'GENERATION' named entity 'ACTIVITY' named entity 'FINDINGS' named entity 'BEING' named entity 'CHRONIC' named entity 'MUTAGENICITY' named entity 'BATTERY' named entity 'MACROSCOPIC' named entity 'EFFICIENCY' named entity 'LEVEL' named entity 'TEST' named entity 'MALE AND FEMALE' named entity 'CONCLUSION' named entity 'OXALATE DECARBOXYLASE' named entity 'DETERMINED' named entity 'METABOLITE' named entity 'SEX' named entity 'LIMIT' named entity 'MOTOR ACTIVITY' named entity 'COULD BE' named entity 'GAVAGE' named entity 'CLINICAL' named entity 'FOOD' named entity 'UPPER' named entity 'ADDED' named entity 'IS A'

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