title: Safety evaluation of AMP deaminase from Aspergillus oryzae.
abstract: Adenosine-5'-monophosphate (AMP) deaminase is an enzyme used to increase concentrations of 5'-inosine monophosphate in certain foods and beverages for flavoring purposes. One commercial source of this enzyme is Aspergillus oryzae, a filamentous fungus with a history of safe use in Asia as a fermentation organism used in the production of miso sauce and sake liquors. Noting the use of the enzyme in food intended for human consumption and potential presence at trace levels in finished goods, a series of safety studies including an in vitro Ames test and chromosome aberration assay with Chinese hamster lung fibroblasts were conducted along with a 90-day oral toxicity study in rats. AMP deaminase showed no evidence of genotoxicity in the in vitro tests. Following gavage administration of Sprague-Dawley rats at dosages of 19.8, 198.4, or 1984 mg total organic solids (TOS)/kg body weight (bw)/day for 90 days, no adverse effects on body weight gain, food consumption, hematology, clinical chemistry, urinalysis, ophthalmological and histopathological examinations were observed. The no-observed-adverse-effect level was considered to be 1984 mg TOS/kg bw/day, the highest dose tested. Results of the genotoxicity studies and subchronic rat study support the safe use of AMP deaminase produced from A. oryzae in food production.
authors.affiliation: Shin Nihon Chemical Co., Ltd., 19-10 Showa-cho, Anjyo, Aichi 446-0063, Japan. Electronic address: nokado@snc-enzymes.co.jp.
authors.forename: Nobuo
authors.initials: N
authors.lastname: Okado
authors.affiliation: Biosafety Research Center, Foods, Drugs, and Pesticides, 582-2, Shioshinden, Iwata, Shizuoka 437-1213, Japan.
authors.forename: Mai
authors.initials: M
authors.lastname: Sugi
authors.affiliation: Biosafety Research Center, Foods, Drugs, and Pesticides, 582-2, Shioshinden, Iwata, Shizuoka 437-1213, Japan.
authors.forename: Maya
authors.initials: M
authors.lastname: Ueda
authors.affiliation: Biosafety Research Center, Foods, Drugs, and Pesticides, 582-2, Shioshinden, Iwata, Shizuoka 437-1213, Japan.
authors.forename: Fukutaro
authors.initials: F
authors.lastname: Mizuhashi
authors.affiliation: Intertek Scientific and Regulatory Consultancy, 2233 Argentia Road, Suite 201, Mississauga, Ontario L5N 2X7, Canada.
authors.forename: Barry S
authors.initials: BS
authors.lastname: Lynch
authors.affiliation: Intertek Scientific and Regulatory Consultancy, 2233 Argentia Road, Suite 201, Mississauga, Ontario L5N 2X7, Canada.
authors.forename: Trung D
authors.initials: TD
authors.lastname: Vo
authors.affiliation: Intertek Scientific and Regulatory Consultancy, 2233 Argentia Road, Suite 201, Mississauga, Ontario L5N 2X7, Canada.
authors.forename: Ashley S
authors.initials: AS
authors.lastname: Roberts
mesh_terms: D000659:AMP Deaminase / Q000633:toxicity*; D000284:Administration, Oral; D000818:Animals; D001236:Aspergillus oryzae / Q000201:enzymology*; D000070585:Cadherin Related Proteins; D015820:Cadherins; D002478:Cells, Cultured; D006224:Cricetinae; D005260:Female; D005347:Fibroblasts / Q000187:drug effects; D008297:Male; D009152:Mutagenicity Tests; D011498:Protein Precursors; D051381:Rats; D012486:Salmonella typhimurium / Q000235:genetics
chemical_list: C418976:CDHR15 protein, mouse; D000070585:Cadherin Related Proteins; D015820:Cadherins; D011498:Protein Precursors; D000659:AMP Deaminase
keywords: Adenosine-5’-monophosphate deaminase; Food; Genotoxicity; Rat; Safety; Subchronic toxicity