SAFETY EVALUATION OF LIPASE DERIVED FROM RHIZOPUS-ORYZAE - SUMMARY OFTOXICOLOGICAL DATA

A lipase enzyme, obtained from Rhizopus oryzae produced by a fermentat ion process was subjected to a series of toxicological tests to docume nt the safety for use as a food additive. The enzyme product was exami ned for acute, subacute and subchronic oral toxicity, and mutagenic po tential. An extensive literature search on the production organism has also been conducted. No evidence of(sub)acute oral toxicity or mutage nic potential was found. Administration of the lipase at dosages of 50 , 200 and 1000 mg/kg body weight/day for 90 days did not induce notice able signs of toxicity. A few minor changes in the chemical compositio n of the blood in the highest dose group were of no toxicological sign ificance. The no-observed-adverse-effect level of the tox-batch in the subchronic toxicity study was 1000 mg/kg body weight/day. It can be c oncluded that no safety concerns were identified in the studies conduc ted with this lipase preparation derived from R. oryzae and produced u nder controlled fermentation conditions. (C) 1997 Elsevier Science Ltd .