Safety Evaluation of Amino Peptidase Enzyme Preparation derived from Aspergillus niger
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 o...
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| Veröffentlicht in: | Food and chemical toxicology 1998-09, Vol.36 (9), p.781-789 |
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| creator | Coenen, T.M.M Aughton, P |
| description | 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 2000
mg/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. |
| doi_str_mv | 10.1016/S0278-6915(98)00041-6 |
| format | Article |
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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 2000
mg/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.</description><identifier>ISSN: 0278-6915</identifier><identifier>EISSN: 1873-6351</identifier><identifier>DOI: 10.1016/S0278-6915(98)00041-6</identifier><identifier>PMID: 9737425</identifier><identifier>CODEN: FCTOD7</identifier><language>eng</language><publisher>Oxford: Elsevier Ltd</publisher><subject>Administration, Oral ; Ames test ; amino peptidase ; aminopeptidases ; Aminopeptidases - administration & dosage ; Aminopeptidases - isolation & purification ; Aminopeptidases - toxicity ; Animals ; Aspergillus niger ; Aspergillus niger - enzymology ; Biological and medical sciences ; Body Weight - drug effects ; Chromosome Aberrations ; Dose-Response Relationship, Drug ; Eating - drug effects ; enzyme preparations ; Female ; Fermentation ; Food Handling - standards ; Food toxicology ; genotoxicity ; Humans ; lymphocytes ; Male ; Medical sciences ; mutagenicity ; Mutagens - toxicity ; No-Observed-Adverse-Effect Level ; oral administration ; Quality Control ; Rats ; Rats, Sprague-Dawley ; safety ; Salmonella typhimurium ; Salmonella typhimurium - drug effects ; Salmonella typhimurium - genetics ; Specific Pathogen-Free Organisms ; T-Lymphocytes - drug effects ; T-Lymphocytes - ultrastructure ; testing ; toxicity ; Toxicology</subject><ispartof>Food and chemical toxicology, 1998-09, Vol.36 (9), p.781-789</ispartof><rights>1998 Elsevier Science Ltd</rights><rights>1998 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c444t-f2f9f516f9c4636a221d73ebbbb1ac39d331ce9a24a8ac827b731ae51cbe61a83</citedby><cites>FETCH-LOGICAL-c444t-f2f9f516f9c4636a221d73ebbbb1ac39d331ce9a24a8ac827b731ae51cbe61a83</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0278691598000416$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=2384886$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/9737425$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Coenen, T.M.M</creatorcontrib><creatorcontrib>Aughton, P</creatorcontrib><title>Safety Evaluation of Amino Peptidase Enzyme Preparation derived from Aspergillus niger</title><title>Food and chemical toxicology</title><addtitle>Food Chem Toxicol</addtitle><description>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 2000
mg/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.</description><subject>Administration, Oral</subject><subject>Ames test</subject><subject>amino peptidase</subject><subject>aminopeptidases</subject><subject>Aminopeptidases - administration & dosage</subject><subject>Aminopeptidases - isolation & purification</subject><subject>Aminopeptidases - toxicity</subject><subject>Animals</subject><subject>Aspergillus niger</subject><subject>Aspergillus niger - enzymology</subject><subject>Biological and medical sciences</subject><subject>Body Weight - drug effects</subject><subject>Chromosome Aberrations</subject><subject>Dose-Response Relationship, Drug</subject><subject>Eating - drug effects</subject><subject>enzyme preparations</subject><subject>Female</subject><subject>Fermentation</subject><subject>Food Handling - standards</subject><subject>Food toxicology</subject><subject>genotoxicity</subject><subject>Humans</subject><subject>lymphocytes</subject><subject>Male</subject><subject>Medical sciences</subject><subject>mutagenicity</subject><subject>Mutagens - toxicity</subject><subject>No-Observed-Adverse-Effect Level</subject><subject>oral administration</subject><subject>Quality Control</subject><subject>Rats</subject><subject>Rats, Sprague-Dawley</subject><subject>safety</subject><subject>Salmonella typhimurium</subject><subject>Salmonella typhimurium - drug effects</subject><subject>Salmonella typhimurium - genetics</subject><subject>Specific Pathogen-Free Organisms</subject><subject>T-Lymphocytes - drug effects</subject><subject>T-Lymphocytes - ultrastructure</subject><subject>testing</subject><subject>toxicity</subject><subject>Toxicology</subject><issn>0278-6915</issn><issn>1873-6351</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1998</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkE2L1EAQhoMo67j6ExZzENFDtKs76Y_TMizjByy4MK7XpqZTPbTky-5kYPz1ZjbDXK1LHep5q4ony26AfQIG8vOWcaULaaD6YPRHxlgJhXyWrUArUUhRwfNsdUFeZq9S-j1DCpS8yq6MEqrk1Sr7tUVP4zHfHLCZcAx9l_c-X7eh6_MHGsZQY6J80_09tpQ_RBowLlRNMRyozn3s23ydBor70DRTyruwp_g6e-GxSfTm3K-zxy-bn3ffivsfX7_fre8LV5blWHjuja9AeuNKKSRyDrUStJsL0AlTCwGODPISNTrN1U4JQKrA7UgCanGdvV_2DrH_M1EabRuSo6bBjvopWVAAUjAzg9UCutinFMnbIYYW49ECsyef9smnPcmyRtsnn1bOuZvzgWnXUn1JnQXO83fnOSaHjY_YuZAuGBe61Pq05u2Ceewt7uOMPG45A8G4Ngx0ORO3C0GzrkOgaJML1DmqQyQ32roP_3n1H79Nm9Q</recordid><startdate>19980901</startdate><enddate>19980901</enddate><creator>Coenen, T.M.M</creator><creator>Aughton, P</creator><general>Elsevier Ltd</general><general>Elsevier Science</general><scope>FBQ</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T2</scope><scope>7U2</scope><scope>7U7</scope><scope>C1K</scope><scope>M7N</scope></search><sort><creationdate>19980901</creationdate><title>Safety Evaluation of Amino Peptidase Enzyme Preparation derived from Aspergillus niger</title><author>Coenen, T.M.M ; Aughton, P</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c444t-f2f9f516f9c4636a221d73ebbbb1ac39d331ce9a24a8ac827b731ae51cbe61a83</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1998</creationdate><topic>Administration, Oral</topic><topic>Ames test</topic><topic>amino peptidase</topic><topic>aminopeptidases</topic><topic>Aminopeptidases - administration & dosage</topic><topic>Aminopeptidases - isolation & purification</topic><topic>Aminopeptidases - toxicity</topic><topic>Animals</topic><topic>Aspergillus niger</topic><topic>Aspergillus niger - enzymology</topic><topic>Biological and medical sciences</topic><topic>Body Weight - drug effects</topic><topic>Chromosome Aberrations</topic><topic>Dose-Response Relationship, Drug</topic><topic>Eating - drug effects</topic><topic>enzyme preparations</topic><topic>Female</topic><topic>Fermentation</topic><topic>Food Handling - standards</topic><topic>Food toxicology</topic><topic>genotoxicity</topic><topic>Humans</topic><topic>lymphocytes</topic><topic>Male</topic><topic>Medical sciences</topic><topic>mutagenicity</topic><topic>Mutagens - toxicity</topic><topic>No-Observed-Adverse-Effect Level</topic><topic>oral administration</topic><topic>Quality Control</topic><topic>Rats</topic><topic>Rats, Sprague-Dawley</topic><topic>safety</topic><topic>Salmonella typhimurium</topic><topic>Salmonella typhimurium - drug effects</topic><topic>Salmonella typhimurium - genetics</topic><topic>Specific Pathogen-Free Organisms</topic><topic>T-Lymphocytes - drug effects</topic><topic>T-Lymphocytes - ultrastructure</topic><topic>testing</topic><topic>toxicity</topic><topic>Toxicology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Coenen, T.M.M</creatorcontrib><creatorcontrib>Aughton, P</creatorcontrib><collection>AGRIS</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Safety Science and Risk</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><jtitle>Food and chemical toxicology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Coenen, T.M.M</au><au>Aughton, P</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety Evaluation of Amino Peptidase Enzyme Preparation derived from Aspergillus niger</atitle><jtitle>Food and chemical toxicology</jtitle><addtitle>Food Chem Toxicol</addtitle><date>1998-09-01</date><risdate>1998</risdate><volume>36</volume><issue>9</issue><spage>781</spage><epage>789</epage><pages>781-789</pages><issn>0278-6915</issn><eissn>1873-6351</eissn><coden>FCTOD7</coden><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 2000
mg/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.</abstract><cop>Oxford</cop><cop>New York, NY</cop><pub>Elsevier Ltd</pub><pmid>9737425</pmid><doi>10.1016/S0278-6915(98)00041-6</doi><tpages>9</tpages></addata></record> |
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| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Administration, Oral Ames test amino peptidase aminopeptidases Aminopeptidases - administration & dosage Aminopeptidases - isolation & purification Aminopeptidases - toxicity Animals Aspergillus niger Aspergillus niger - enzymology Biological and medical sciences Body Weight - drug effects Chromosome Aberrations Dose-Response Relationship, Drug Eating - drug effects enzyme preparations Female Fermentation Food Handling - standards Food toxicology genotoxicity Humans lymphocytes Male Medical sciences mutagenicity Mutagens - toxicity No-Observed-Adverse-Effect Level oral administration Quality Control Rats Rats, Sprague-Dawley safety Salmonella typhimurium Salmonella typhimurium - drug effects Salmonella typhimurium - genetics Specific Pathogen-Free Organisms T-Lymphocytes - drug effects T-Lymphocytes - ultrastructure testing toxicity Toxicology |
| title | Safety Evaluation of Amino Peptidase Enzyme Preparation derived from Aspergillus niger |
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