Preclinical safety evaluation of Lipase OF from Candida cylindracea.

Triacylglycerol lipases are enzymes commonly used to process foods and beverages such as oils, wines, and cheeses through catalyzation of long-chain triglyceride hydrolysis. Lipase OF derived from Candida cylindracea (strain MS-5-OF) is only intended for use as a processing aid in food production applications; however, it may be present at trace levels in some products. As such, the safety of Lipase OF was evaluated in this study that included a bacterial reverse mutation assay, an in vitro chromosome aberration test, and a 90-day subchronic toxicity study in rats. In the in vitro bacterial reverse mutation and chromosome aberration assays, Lipase OF was not observed to be mutagenic at concentrations up to 5000 µg/plate and 50 µg/ml, respectively, in the presence or absence of metabolic activation. Results from the 90-day subchronic toxicity study indicated only minimal adverse effects (i.e., increased platelet count and prothrombin time) in male rats from the high-dose group following administration of Lipase OF via the diet at levels of 0, 1.0, 2.5, and 5.0 w/w%. The no-observed-adverse-effect level (NOAEL) for Lipase OF was therefore considered 2.5 w/w% (1597.6 mg/kg body weight/day [1027.3 mg TOS/kg body weight/day]) in males and 5.0 w/w% (3700.4 mg/kg body weight/day [2379.4 mg TOS/kg body weight/day]) in females under the test conditions. Thus, the evidence presented within this study supports the safe use of Lipase OF as a processing aid in various food production applications for human consumption.

Toxicological evaluation of Phospholipase D from Kitasatospora paracochleata.

Phospholipases are used extensively in the production of food ingredients, typically as processing aids, to enzymatically convert glycerophospholipids and provide functional properties in meat products or baking confections. The current study examined the safety of Phospholipase D derived from Kitasatospora paracochleata (strain No. 362-PLD) for use as a processing aid in various food applications, where it may be present in the finished products at trace levels. The safety assessment of Phospholipase D included two in vitro genotoxicity studies and a 90-day subchronic toxicity study in rats. No evidence of genotoxicity was observed in a bacterial reverse mutation test or in a chromosome aberration test. In the subchronic toxicity study, no test article-related adverse effects were observed upon Phospholipase D administration to rats at doses levels of 0, 750, 1500, and 3000 mg/kg body weight/day throughout a 90-day study period. Thus, the no-observed-adverse-effect level (NOAEL) was considered to be 3000 mg/kg body weight/day. This safety assessment supports the safe use of Phospholipase D as a processing aid in food production and the presence of trace levels in finished products.