Preclinical safety evaluation of triacylglycerol lipase QLM from Burkholderia ubonensis

Abstract

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.