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.