Document Detail


14-day repeat-dose oral toxicity evaluation of oxazyme in rats and dogs.
MedLine Citation:
PMID:  19996128     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Oxazyme (OC4) is an orally administered formulation that has as an active component a recombinant mutant form of Bacillus subtilis oxalate decarboxylase (OxDC) enzyme C383S, designed to degrade dietary oxalate in the stomach. Fourteen-day repeat-dose studies were conducted in rats and dogs to evaluate toxicity and determine a no observed adverse effect level (NOAEL). Animals were administered OC4 by oral gavage twice daily for 14 consecutive days. Reversibility, progression, and delayed appearance of any observed changes were evaluated in a subset of animals that underwent a recovery of 7 days following 14 days of control or test-article. There were no test-article-related adverse effects or deaths in either species. Results indicate that the NOAEL under the conditions used in the studies was 720.8 mg/kg/d in rats and 187.2 mg/kg/d in dogs, the high dose tested in each species.
Authors:
Aaron B Cowley; Duane W Poage; Robin R Dean; Carol L Meschter; Majid Ghoddusi; Qing-Shan Li; Harmeet Sidhu
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Publication Detail:
Type:  Journal Article     Date:  2009-12-07
Journal Detail:
Title:  International journal of toxicology     Volume:  29     ISSN:  1092-874X     ISO Abbreviation:  Int. J. Toxicol.     Publication Date:    2010 Jan-Feb
Date Detail:
Created Date:  2010-01-15     Completed Date:  2010-03-23     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9708436     Medline TA:  Int J Toxicol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  20-31     Citation Subset:  IM    
Affiliation:
Captozyme LLC, Gainesville, FL, USA.
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Animals
Blood Chemical Analysis
Carboxy-Lyases / administration & dosage,  toxicity*
Dogs
Female
Hematologic Tests
Male
No-Observed-Adverse-Effect Level
Rats
Recombinant Proteins / administration & dosage,  toxicity*
Toxicity Tests
Urinalysis
Chemical
Reg. No./Substance:
0/Recombinant Proteins; EC 4.1.1.-/Carboxy-Lyases; EC 4.1.1.2/oxalate decarboxylase

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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