Vo Trung Duc, Sulaiman Christina, Tafazoli Shahrzad, Lynch Barry, Roberts Ashley, Chikamatsu Go
Intertek Health Sciences Inc. Mississauga ON Canada.
AR Toxicology Inc. Oakville ON Canada.
Food Sci Nutr. 2020 Feb 18;8(3):1433-1450. doi: 10.1002/fsn3.1426. eCollection 2020 Mar.
Glutaminase (glutamine aminohydrolase EC 3.5.1.2) is used in the production of food ingredients rich in l-glutamic acid that are added to finished foods for the purpose of enhancing or improving the savory flavor profile of food. The glutaminase enzyme preparation evaluated in these studies, designated as Sumizyme GT hereafter, is obtained by fermentation of strain GT147. The safety of Sumizyme GT was evaluated in a series of standard toxicological studies, including a 90-day oral toxicity study in rats, an in vitro bacterial reverse mutation assay, an in vitro mammalian chromosome aberration test, and an in vivo alkaline Comet assay. Sumizyme GT was not mutagenic or genotoxic, and administration of the enzyme by gavage at doses up to 2,570 mg total organic solids (TOS)/kg body weight (bw) per day for 90 days was without any systemic toxicity. The no-observed-adverse-effect level was concluded to be 2,570 mg TOS/kg bw per day, the highest dose tested. Considering that has an established history of safe use in the food industry and its safety in the production of food ingredients and food enzymes is well documented, the results of these studies provide further support of the safety of glutaminase from when used in food production.
谷氨酰胺酶（谷氨酰胺氨基水解酶，EC 3.5.1.2）用于生产富含L-谷氨酸的食品配料，这些配料被添加到成品食品中，以增强或改善食品的风味。在这些研究中评估的谷氨酰胺酶制剂，以下简称Sumizyme GT，是通过GT147菌株发酵获得的。Sumizyme GT的安全性在一系列标准毒理学研究中进行了评估，包括大鼠90天口服毒性研究、体外细菌回复突变试验、体外哺乳动物染色体畸变试验和体内碱性彗星试验。Sumizyme GT没有致突变性或基因毒性，每天以高达2570毫克总有机固体（TOS）/千克体重（bw）的剂量通过灌胃给药90天，没有任何全身毒性。未观察到不良反应水平被确定为每天2570毫克TOS/千克bw，这是测试的最高剂量。鉴于其在食品工业中有安全使用的既定历史，并且其在食品配料和食品酶生产中的安全性有充分记录，这些研究结果进一步支持了谷氨酰胺酶在食品生产中使用时的安全性。
