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Genotoxicity,acute and subchronic toxicity evaluation of savory food ingredients
Institution:1. Intertek Scientific and Regulatory Consultancy, 2233 Argentia Road, Suite 201, Mississauga L5N 2X7, ON, Canada;2. Nestlé Product Technology Centre Lebensmittelforschung GmbH, Lange Str.21, 78224 Singen, Germany;3. Nestec Ltd., P.O. Box 44, CH-1000 Lausanne 26, Switzerland;4. Nestlé Institute of Health Sciences SA, EPFL Innovation Park, Building H, CH-1015 Lausanne, Switzerland;5. Aurigon GmbH, Machtlfinger Straße 13, 81379 München, Germany;6. Intertek Scientific & Regulatory Consultancy, Room 1036, Building A8, Cody Technology Park, Ively Road, Farnborough, Hampshire, GU14 0LX, UK;1. School of Medicine and Institute for Nuclear Science and Technology, Jeju National University, Jeju 690-756, Republic of Korea;2. Department of Mechanical Engineering & Graduate School of Medical Science and Engineering, KAIST, Daejeon 305-701, Republic of Korea;3. National Fusion Research Institute, Plasma Technology Research Center, Gunsan 573-540, Republic of Korea;1. Unit for the Clinical Management of Digestive Diseases, Valme University Hospital & CIBERehd, Sevilla, Spain;2. Digestive Department, Puerta de Hierro Hospital, Madrid, Spain;3. Digestive Department, Hospital Marqués de Valdecilla, Santander, Spain;4. Hepatology Unit, Hospital Clinic and IDIBAPS & CIBERehd, Barcelona, Spain;5. Digestive Unit, Hospital Virgen de la Victoria & CIBERehd, Málaga, Spain;6. Hepatology Unit, Hospital Vall d’Hebron & CIBERehd, Barcelona, Spain;7. Hepatology Unit, Hospital 12 de Octubre, Madrid, Spain;1. c/o Julius Kuehn Institute, Federal Research Center for Cultivated Plants, Institute for Epidemiology and Pathogen Diagnostics, Messeweg 11, D38104 Braunschweig, Germany;2. Julius Kuehn Institute, Federal Research Center for Cultivated Plants, Institute for Plant Protection in Field Crops and Grassland, Messeweg 11, D38104 Braunschweig, Germany;1. Fuda Cancer Hospital, Jinan University School of Medicine, No. 2 Tangdexi Road, Tianhe District, Guangzhou 510665, China;2. Fuda Institute of Cryosurgery for Cancer, No. 2 Tangdexi Road, Tianhe District, Guangzhou 510665, China;1. Institute of Agricultural Engineering, The Faculty of Life Sciences and Technology, Wroclaw University of Environmental and Life Sciences, pl. Grunwaldzki 24A, 50-363 Wroc?aw, Poland;2. Institute of Machine Design and Operation, Wroclaw University of Technology, ?ukasiewicza 7/9, 50-371 Wroc?aw, Poland
Abstract:The potential toxicity of two savory food ingredients produced by fermentation of enzymatically hydrolyzed corn starch (Savory Base 100 and Savory Base 200) was evaluated individually in a bacterial reverse mutation assay, an in vitro mammalian cell gene mutation assay, an acute oral study and as a mixture in a 90-day dietary study. In the bacterial reverse mutation and in vitro mammalian cell gene mutation assays, neither ingredient was mutagenic at concentrations up to 5000 μg/plate and 5000 μg/mL, respectively in the presence and absence of metabolic activation. In the acute study, the no-observed-adverse-effect level (NOAEL) for each Savory Base 100 and Savory Base 200 in male and female rats was 2000 mg/kg body weight. In the 90-day study, the hematology and clinical chemistry findings and histopathological changes noted in the liver, heart and kidneys were deemed to be of no toxicological significance, as the mean values were within the historical control range, were not dose-dependent, occurred at a similar frequency in control groups, or only occurred in the control group. Considering these findings, the NOAEL for Savory Base 100 and Savory Base 200 was 2333 and 1167 mg/kg body weight, respectively, the highest dose tested in each case.
Keywords:L-alanine  Formic acid  Succinic acid  Glutamic acid  glycine  Inosine 5′-monophosphate  Rat  Genotoxicity  Subchronic toxicity  Safety  2-AA"}  {"#name":"keyword"  "$":{"id":"kwrd0065"}  "$$":[{"#name":"text"  "_":"2-aminoanthracene  9-AA"}  {"#name":"keyword"  "$":{"id":"kwrd0075"}  "$$":[{"#name":"text"  "_":"9-aminoacridine  A/G"}  {"#name":"keyword"  "$":{"id":"kwrd0085"}  "$$":[{"#name":"text"  "_":"albumin/globulin  APTT"}  {"#name":"keyword"  "$":{"id":"kwrd0095"}  "$$":[{"#name":"text"  "_":"activated partial thromboplastin time  bw"}  {"#name":"keyword"  "$":{"id":"kwrd0105"}  "$$":[{"#name":"text"  "_":"body weight  DMBA"}  {"#name":"keyword"  "$":{"id":"kwrd0115"}  "$$":[{"#name":"text"  "_":"7  12-dimethyl benzanthracene  DMEM"}  {"#name":"keyword"  "$":{"id":"kwrd0125"}  "$$":[{"#name":"text"  "_":"Dulbecco's Modified Eagle's medium  DMSO"}  {"#name":"keyword"  "$":{"id":"kwrd0135"}  "$$":[{"#name":"text"  "_":"dimethyl sulfoxide  EFSA"}  {"#name":"keyword"  "$":{"id":"kwrd0145"}  "$$":[{"#name":"text"  "_":"European Food Safety Authority  EMS"}  {"#name":"keyword"  "$":{"id":"kwrd0155"}  "$$":[{"#name":"text"  "_":"ethylmethane sulphonate  GLP"}  {"#name":"keyword"  "$":{"id":"kwrd0165"}  "$$":[{"#name":"text"  "_":"good laboratory practice  IMP"}  {"#name":"keyword"  "$":{"id":"kwrd0175"}  "$$":[{"#name":"text"  "_":"inosine-5’-monophosphate  MMS"}  {"#name":"keyword"  "$":{"id":"kwrd0185"}  "$$":[{"#name":"text"  "_":"methylmethanesulfonate  MSG"}  {"#name":"keyword"  "$":{"id":"kwrd0195"}  "$$":[{"#name":"text"  "_":"monosodium glutamate  sodium azide  NOAEL"}  {"#name":"keyword"  "$":{"id":"kwrd0215"}  "$$":[{"#name":"text"  "_":"no-observed-adverse-effect level  NPD"}  {"#name":"keyword"  "$":{"id":"kwrd0225"}  "$$":[{"#name":"text"  "_":"4-nitro-1  2-phenylene-diamine  OECD"}  {"#name":"keyword"  "$":{"id":"kwrd0235"}  "$$":[{"#name":"text"  "_":"Organisation for the Economic and Cooperative Development  QPS"}  {"#name":"keyword"  "$":{"id":"kwrd0245"}  "$$":[{"#name":"text"  "_":"qualified presumption of safety  RBC"}  {"#name":"keyword"  "$":{"id":"kwrd0255"}  "$$":[{"#name":"text"  "_":"red blood cells  RCDW"}  {"#name":"keyword"  "$":{"id":"kwrd0265"}  "$$":[{"#name":"text"  "_":"red cell distribution width
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