Triacylglycerol lipases are well characterized enzymes that catalyze the hydrolysis of fats. They are biotechnologically relevant enzymes and are used in a wide range of practical applications in industry. Lipase produced from Burkholderia ubonensis (strain PL266-QLM) (Lipase QLM) is being investigated for use as a processing aid in multiple food applications and may therefore be present at trace levels in finished food products. A battery of toxicological studies was therefore conducted on Lipase QLM to support its safe use in food. Lipase QLM was not genotoxic or mutagenic in an in vitro bacterial reverse mutation test and chromosome aberration test. Additionally, no test article-related adverse effects were observed in clinical observations, body weight, food consumption, ophthalmology, hematology, blood chemistry, urinalysis, and macroscopic and microscopic findings in a subchronic toxicity study in rats administered Lipase QLM in the diet at levels of 0%, 0.8%, 2%, and 5% Lipase QLM. The no-observed-adverse-effect level was therefore considered to be 5% Lipase QLM in both sexes [3357.2 and 3777.6 mg/kg body weight/day (2756.3 and 3101.4 mg total organic solids/kg body weight/day) in males and females, respectively] under the test conditions, which supports the safety of this ingredient for use in food for human consumption.

中文翻译：

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乌骨伯克霍尔德菌中三酰基甘油脂酶QLM的临床前安全性评估。

三酰基甘油脂肪酶是催化脂肪水解的特征明确的酶。它们是与生物技术相关的酶，在工业中广泛用于实际应用中。目前正在研究从乌节伯克霍尔德氏菌（PL266-QLM菌株）生产的脂肪酶（脂肪酶QLM）在多种食品中用作加工助剂，因此在成品食品中可能以痕量含量存在。因此，对Lipase QLM进行了一系列毒理学研究，以支持其在食品中的安全使用。在体外细菌反向突变试验和染色体畸变试验中，脂肪酶QLM没有遗传毒性或致突变性。此外，在临床观察，体重，食物消耗，眼科，血液学，血液化学，尿液分析，以及在饮食中施用脂肪酶QLM含量为0％，0.8％，2％和5％脂肪酶QLM的大鼠的亚慢性毒性研究中的宏观和微观发现。因此，在男性和女性中，未观察到的不良反应水平为男女的5％脂肪酶QLM [3357.2和3777.6 mg / kg体重/天（总有机固体2756.3和3101.4 mg / kg体重/天）。雌性]在测试条件下，这支持了该成分在人类食用食品中使用的安全性。