title: Safety evaluation of phytase 50104 enzyme preparation (also known as VR003), expressed in Pseudomonas fluorescens, intended for increasing digestibility of phytate in monogastrics.
abstract: Phytase 50104 enzyme (also known as VR003) can be added to swine and poultry diets to catalyze the hydrolysis of phosphate from phytic acid, thereby increasing phosphorus bioavailability in these animals. This enzyme was produced from a Pseudomonas fluorescens (P. fluorescens) production strain and was tested in acute, subchronic and genotoxicity studies. Dosages of the test article preparation ranged from 5000μg/plate for in vitro toxicity studies to 2000mg/kg/day for in vivo toxicity studies. The highest oral dose tested in vivo (NOAEL of 2000mg/kg/day) resulted in a safety margin of 5870 based on TOS and a conservative estimate of total poultry consumption at the highest inclusion rate. There was no toxicity reported for any of these studies or in the following additional safety studies: eye irritation, dermal irritation, and delayed hypersensitivity studies. A review of the public literature indicated that P. fluorescens fulfilled the recognized safety criteria pertinent to microbial production strains used in the manufacture of food/feed enzyme preparations. The results of the toxicity studies presented herein attest to the safety of phytase 50104 enzyme for its intended use.
authors.affiliation: Verenium Corporation, 3550 John Hopkins Ct, San Diego, CA 92121, USA.
authors.forename: Scott
authors.initials: S
authors.lastname: Krygier
authors.affiliation: Verenium Corporation, 3550 John Hopkins Ct, San Diego, CA 92121, USA.
authors.forename: Arne
authors.initials: A
authors.lastname: Solbak
authors.affiliation: Verenium Corporation, 3550 John Hopkins Ct, San Diego, CA 92121, USA. Electronic address: diane.shanahan@basf.com.
authors.forename: Diane
authors.initials: D
authors.lastname: Shanahan
authors.affiliation: Shoreline Toxicology, LLC, 53 River Walk, Branford, CT 06405, USA. Electronic address: vbc6@juno.com.
authors.forename: Vince
authors.initials: V
authors.lastname: Ciofalo
mesh_terms: D010832:6-Phytase / Q000009:adverse effects*; D000328:Adult; D000821:Animal Feed / Q000009:adverse effects; D000818:Animals; D002478:Cells, Cultured; D019587:Dietary Supplements / Q000009:adverse effects; D004063:Digestion / Q000187:drug effects*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D051379:Mice; D008813:Mice, Inbred ICR; D010833:Phytic Acid / Q000009:adverse effects; D011551:Pseudomonas fluorescens / Q000378:metabolism*; D051381:Rats; D017207:Rats, Sprague-Dawley; D012449:Safety
chemical_list: D010833:Phytic Acid; D010832:6-Phytase
keywords: Enzyme; Phosphorus; Phytase; Poultry; Pseudomonas fluorescens; Safety; Swine; Toxicology