Tmm. Coenen et al., SAFETY EVALUATION OF LIPASE DERIVED FROM RHIZOPUS-ORYZAE - SUMMARY OFTOXICOLOGICAL DATA, Food and chemical toxicology, 35(3-4), 1997, pp. 315-322
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
.