title: Safety evaluation of amino peptidase enzyme preparation derived from Aspergillus niger.
abstract: An amino peptidase enzyme preparation obtained from Aspergillus niger was subjected to a series of toxicological tests to document the safety for use as a processing aid for food. The enzyme preparation was examined for subacute and subchronic oral toxicity, and mutagenic potential. No evidence of oral toxicity or mutagenicity was found. Administration of the amino peptidase enzyme preparation at doses of 500, 1000 and 2000 mg/kg body weight/day for 90 days did not induce noticeable signs of toxicity. The no-observed-adverse-effect level (NOAEL) of the enzyme preparation in the subchronic toxicity study was 2000mg/kg body weight/day (equivalent to 1152 PHEA units/kg body weight/day). It can be concluded that no safety concerns were identified in the studies conducted with this amino peptidase enzyme preparation derived from Aspergillus niger and produced under controlled fermentation conditions.
authors.affiliation: Gist-Brocades B.V., Delft, The Netherlands.
authors.forename: T M
authors.initials: TM
authors.lastname: Coenen
authors.forename: P
authors.initials: P
authors.lastname: Aughton
mesh_terms: D000284:Administration, Oral; D000626:Aminopeptidases / Q000008:administration & dosage / Q000302:isolation & purification / Q000633:toxicity*; D000818:Animals; D001234:Aspergillus niger / Q000201:enzymology*; D001835:Body Weight / Q000187:drug effects; D002869:Chromosome Aberrations; D004305:Dose-Response Relationship, Drug; D004435:Eating / Q000187:drug effects; D005260:Female; D005285:Fermentation; D005511:Food Handling / Q000592:standards; D006801:Humans; D008297:Male; D009153:Mutagens / Q000633:toxicity*; D019055:No-Observed-Adverse-Effect Level; D011786:Quality Control; D051381:Rats; D017207:Rats, Sprague-Dawley; D012486:Salmonella typhimurium / Q000187:drug effects / Q000235:genetics; D013047:Specific Pathogen-Free Organisms; D013601:T-Lymphocytes / Q000187:drug effects* / Q000648:ultrastructure
chemical_list: D009153:Mutagens; D000626:Aminopeptidases