Verenium Corporation, 3550 John Hopkins Ct. San Diego, CA 92121, USA.
Regul Toxicol Pharmacol. 2012 Oct;64(1):87-94. doi: 10.1016/j.yrtph.2012.06.006. Epub 2012 Jun 15.
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.
脂肪酶 BD29241 棕榈酶可用作加工助剂，用于从油脂精炼生产过程中的三酰基甘油中去除棕榈酸。这种酶由荧光假单胞菌（P. fluorescens）生产菌株生产，并在急性、吸入和亚慢性毒性研究中进行了测试。此外，还测试了这种酶是否具有遗传毒性。测试制剂的剂量范围从体外毒性研究的 5000μg/平板到体内毒性研究的 2000mg/kg/天。体内测试的最高口服剂量（2000mg/kg/天的无观察到不良作用水平）基于对 BD29241 棕榈酶总人体摄入量的保守估计（0.819mg/kg/天），安全性余量为 2.442×10(3)。这些研究，包括额外的安全性研究，均未报告任何毒性。文献综述表明，荧光假单胞菌符合与用于食品酶制剂生产的微生物生产菌株相关的公认安全性标准。本文所述毒性研究的结果证明了 BD29241 棕榈酶在上述预期用途下的安全性。
