Safety evaluation of lipase derived from Rhizopus oryzae: Summary of toxicological data
| Autor: | T.M.M. Coenen, P Aughton, Hans Verhagen |
|---|---|
| Rok vydání: | 1997 |
| Předmět: |
Male
Salmonella typhimurium No-observed-adverse-effect level Rhizopus oryzae Triacylglycerol lipase Administration Oral Toxicology Median lethal dose Lethal Dose 50 Mice Toxicity Tests Animals Food science Lipase No-Observed-Adverse-Effect Level Hematologic Tests Micronucleus Tests biology Mutagenicity Tests Chemistry food and beverages General Medicine biology.organism_classification Acute toxicity Rats Blood chemistry Chemistry Clinical Toxicity biology.protein Drug Evaluation Female Safety Rhizopus Food Science |
| Zdroj: | Food and Chemical Toxicology. 35:315-322 |
| ISSN: | 0278-6915 |
| DOI: | 10.1016/s0278-6915(97)00006-9 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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