Safety evaluation of lipase derived from Rhizopus oryzae: Summary of toxicological data

• Published in: Food and chemical toxicology Vol. 35; no. 3; pp. 315 - 322
• Main Authors: Coenen, T.M.M., Aughton, P., Verhagen, H.
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier Ltd 01.03.1997; New York, NY Elsevier Science
• Subjects: acute toxicity; Administration, Oral; Animals; Biological and medical sciences; blood chemistry; Chemistry, Clinical; Drug Evaluation; enzyme preparations; Female; Food toxicology; Hematologic Tests; hematology; Lethal Dose 50; Lipase - isolation & purification; Lipase - toxicity; Male; Medical sciences; Mice; Micronucleus Tests; mutagenicity; Mutagenicity Tests; No-Observed-Adverse-Effect Level; oral administration; Rats; Rhizopus - enzymology; Rhizopus oryzae; Safety; Salmonella typhimurium; subacute toxicity; subchronic toxicity; testing; toxicity; Toxicity Tests; Toxicology; triacylglycerol lipase; AST; OECD; TCA; DMSO; NOAEL; SPF; ALT; TOS; PLi; Rat; Enzyme; Mutagenicity testing; Toxicity; Phycomycetes; Rodentia; Oral administration; Triacylglycerol lipase; Esterases; Food additive; Harmlessness; Fermentation; Fermented product; Carboxylic ester hydrolases; Fungi; Vertebrata; Mammalia; Rhizopus oryzae; Hydrolases; Thallophyta
• ISSN: 0278-6915; 1873-6351
• DOI: 10.1016/S0278-6915(97)00006-9

A lipase enzyme, obtained from Rhizopus oryzae produced by a fermentation process was subjected to a series of toxicological tests to document the safety for use as a food additive. The enzyme product was examined for acute, subacute and subchronic oral toxicity, and mutagenic potential. An extensive literature search on the production organism has also been conducted. No evidence of (sub)acute oral toxicity or mutagenic 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 noticeable signs of toxicity. A few minor changes in the chemical composition of the blood in the highest dose group were of no toxicological significance. 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 concluded that no safety concerns were identified in the studies conducted with this lipase preparation derived from R. oryzae and produced under controlled fermentation conditions.