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Safety Evaluation of Lipase Derived From Rhizopus Oryzae: Summary of Toxicological Data

Safety Evaluation of Lipase Derived From Rhizopus Oryzae: Summary of Toxicological Data

T M Coenen, P Aughton, H Verhagen

Food Chem Toxicol. Mar-Apr 1997;35(3-4):315-22.

PMID: 9207893

Abstract:

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.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP9016186-F	Esterase from Rhizopus oryzae		9016-18-6	Price

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