Safety evaluation of a β-mannanase enzyme preparation produced with Thermothelomyces thermophilus expressing a protein-engineered β-mannanase gene

Autor: Diane Shanahan, Andreas Kern, Roland Buesen, Dominik Geiger
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Male
Physiology
Sordariales
Protozoology
Micronuclei
Toxicology
Pathology and Laboratory Medicine
Protein Engineering
White Blood Cells
Animal Cells
Oral administration
Medicine and Health Sciences
Oral Administration
Lymphocytes
Food science
Routes of Administration
chemistry.chemical_classification
Multidisciplinary
biology
Chemistry
Respiration
Thermus thermophilus
Inhalation
Toxicity
Micronucleus test
Medicine
Female
Cellular Types
Anatomy
Research Article
No-observed-adverse-effect level
Dose
Immune Cells
Science
Immunology
Microbiology
Industrial Microbiology
Bacterial Proteins
Ocular System
Animals
Humans
Thermus
Rats
Wistar
Pharmacology
No-Observed-Adverse-Effect Level
Blood Cells
Bacteria
Organisms
beta-Mannosidase
Biology and Life Sciences
Cell Biology
biology.organism_classification
Animal Feed
In vitro
Thermus Thermophilus
Enzyme
Eyes
Physiological Processes
Head
Zdroj: PLoS ONE, Vol 15, Iss 12, p e0243647 (2020)
PLoS ONE
ISSN: 1932-6203
Popis: Mannanase 19287 enzyme is an engineered β-mannanase that can be added to diets for animals raised for human consumption to hydrolyze β-mannans. Established toxicological analyses were conducted with the enzyme preparation to ensure the safety of this product for the intended use. The mannanase 19287 preparation was produced with Thermothelomyces thermophilus strain DSM 33149. In vitro toxicity studies presented here used dosages of the mannanase 19287 test articles up to 5000 μg/plate. For in vivo toxicity studies in Wistar rats, test articles were administered at 5.1 mg/L for inhalation toxicity and up to 15,000 mg/kg rat feed for oral toxicity, based on the Total Organic Solids (TOS) content in each test article. No treatment related adverse effects were reported in any study. The No Observed Adverse Effect Levels in the high dose group of the subchronic oral toxicity study were calculated as 1117–1298 mg TOS/kg bw/day in rats. Comparing these values to an Estimated Daily Intake for poultry demonstrated safety factors larger than 5000. Our results confirm that T. thermophilus fulfills the recognized safety criteria for the manufacture of food enzyme preparations and represent the first peer-reviewed safety evaluation of an enzyme preparation by T. thermophilus. The results of the toxicity studies presented herein attest to the safety of the mannanase 19287 enzyme for its intended use.
Databáze: OpenAIRE
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje