Safety evaluation of a lipase enzyme (BD29241 Palmitase) preparation, expressed in Pseudomonas fluorescens, intended for removing palmitic acid from triacylglycerol.
The lipase enzyme, BD29241 Palmitase, can be used as a processing aid for removing palmitic acid from triacylglycerol in the production of refined oil. This enzyme was produced from a Pseudomonas fluorescens (P. fluorescens) production strain and was tested in acute, inhalation, and subchronic toxicity studies. In addition, this enzyme was also tested for its potential to induce genotoxicity. 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 2.442×10(3) based on a conservative estimate of the total human consumption of BD29241 Palmitase of 0.819mg/kg/day. There was no toxicity reported for any of these studies including additional safety studies. A review of the literature indicates that P. fluorescens fulfills recognized safety criteria pertinent to microbial production strains used in the manufacture of food enzyme preparations. The results of the toxicity studies presented herein attest to the safety of BD29241 Palmitase for its above-stated intended use.
Verenium Corporation, 3550 John Hopkins Ct. San Diego, CA 92121, USA. roxanna.halich@verenium.com
Roxanna
R
Halich
Katie
K
Kline
Diane
D
Shanahan
Vince
V
Ciofalo
D000818:Animals; D002265:Carboxylic Ester Hydrolases / Q000378:metabolism / Q000633:toxicity*; D002869:Chromosome Aberrations / Q000139:chemically induced; D017449:Dermatitis, Allergic Contact / Q000209:etiology / Q000276:immunology / Q000473:pathology; D004305:Dose-Response Relationship, Drug; D005128:Eye Diseases / Q000139:chemically induced / Q000473:pathology; D006168:Guinea Pigs; D006801:Humans; D019570:Inhalation Exposure; D007928:Lethal Dose 50; D008214:Lymphocytes / Q000187:drug effects / Q000473:pathology; D051379:Mice; D048629:Micronuclei, Chromosome-Defective / Q000139:chemically induced; D009153:Mutagens / Q000378:metabolism / Q000633:toxicity; D019055:No-Observed-Adverse-Effect Level; D010938:Plant Oils / Q000378:metabolism / Q000633:toxicity*; D011551:Pseudomonas fluorescens / Q000201:enzymology*; D011817:Rabbits; D051381:Rats; D017207:Rats, Sprague-Dawley; D018570:Risk Assessment; D012449:Safety; D012486:Salmonella typhimurium / Q000187:drug effects / Q000235:genetics; D018675:Toxicity Tests; D014280:Triglycerides / Q000378:metabolism*
D009153:Mutagens; D010938:Plant Oils; D014280:Triglycerides; D002265:Carboxylic Ester Hydrolases; C063418:long-chain carboxylesterase