{"title":"在28天和90天的Sprague-Dawley大鼠饮食毒性研究中证实了味精的安全性。","authors":"Shintaro Yoshida, Huichia Chao, Keigi Chin, Masanori Kohmura","doi":"10.1016/j.yrtph.2025.105897","DOIUrl":null,"url":null,"abstract":"<div><div>The commonly used flavor enhancer monosodium glutamate (MSG) has been part of the human diet for many years and has undergone safety evaluation by several international scientific committees and regulatory agencies. Numerous studies exist on MSG but many of these studies are not consistent or representative of how humans are exposed to MSG (<em>i.e.</em>, ingestion of food). Two GLP-compliant dietary rodent studies were summarized in evaluations performed by EFSA (2017) and JECFA (2022) but were never published. In the first study, groups of Sprague-Dawley rats (10 rats/sex/group) were fed diets containing 0 ppm (basal diet) or 50,000 ppm MSG for 29 days. In the second study, groups of Sprague-Dawley rats (20 rats/sex/group) were fed diets containing 0 (basal diet), 0.5, 1.5, or 5 % (w/w) MSG for 92–96 days. Animals in both studies underwent clinical examinations, hematology and biochemistry tests, full necropsies, and histopathological examination. No toxicologically significant findings were reported in either study. In the 28-day study, there were no adverse effects observed at 5100 mg/kg bw/day (males) and 4800 mg/kg bw/day (females). In the 90-day study, a no-observed-adverse-effect level (NOAEL) was identified as the highest dose tested of 3170 mg/kg bw/day (males) and 3620 mg/kg bw/day (females) or more.</div></div>","PeriodicalId":20852,"journal":{"name":"Regulatory Toxicology and Pharmacology","volume":"162 ","pages":"Article 105897"},"PeriodicalIF":3.5000,"publicationDate":"2025-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"The safety of monosodium glutamate demonstrated in 28-day and 90-day dietary toxicity studies with Sprague-Dawley rats\",\"authors\":\"Shintaro Yoshida, Huichia Chao, Keigi Chin, Masanori Kohmura\",\"doi\":\"10.1016/j.yrtph.2025.105897\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><div>The commonly used flavor enhancer monosodium glutamate (MSG) has been part of the human diet for many years and has undergone safety evaluation by several international scientific committees and regulatory agencies. Numerous studies exist on MSG but many of these studies are not consistent or representative of how humans are exposed to MSG (<em>i.e.</em>, ingestion of food). Two GLP-compliant dietary rodent studies were summarized in evaluations performed by EFSA (2017) and JECFA (2022) but were never published. In the first study, groups of Sprague-Dawley rats (10 rats/sex/group) were fed diets containing 0 ppm (basal diet) or 50,000 ppm MSG for 29 days. In the second study, groups of Sprague-Dawley rats (20 rats/sex/group) were fed diets containing 0 (basal diet), 0.5, 1.5, or 5 % (w/w) MSG for 92–96 days. Animals in both studies underwent clinical examinations, hematology and biochemistry tests, full necropsies, and histopathological examination. No toxicologically significant findings were reported in either study. In the 28-day study, there were no adverse effects observed at 5100 mg/kg bw/day (males) and 4800 mg/kg bw/day (females). In the 90-day study, a no-observed-adverse-effect level (NOAEL) was identified as the highest dose tested of 3170 mg/kg bw/day (males) and 3620 mg/kg bw/day (females) or more.</div></div>\",\"PeriodicalId\":20852,\"journal\":{\"name\":\"Regulatory Toxicology and Pharmacology\",\"volume\":\"162 \",\"pages\":\"Article 105897\"},\"PeriodicalIF\":3.5000,\"publicationDate\":\"2025-06-24\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Regulatory Toxicology and Pharmacology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0273230025001278\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICINE, LEGAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Regulatory Toxicology and Pharmacology","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0273230025001278","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, LEGAL","Score":null,"Total":0}
The safety of monosodium glutamate demonstrated in 28-day and 90-day dietary toxicity studies with Sprague-Dawley rats
The commonly used flavor enhancer monosodium glutamate (MSG) has been part of the human diet for many years and has undergone safety evaluation by several international scientific committees and regulatory agencies. Numerous studies exist on MSG but many of these studies are not consistent or representative of how humans are exposed to MSG (i.e., ingestion of food). Two GLP-compliant dietary rodent studies were summarized in evaluations performed by EFSA (2017) and JECFA (2022) but were never published. In the first study, groups of Sprague-Dawley rats (10 rats/sex/group) were fed diets containing 0 ppm (basal diet) or 50,000 ppm MSG for 29 days. In the second study, groups of Sprague-Dawley rats (20 rats/sex/group) were fed diets containing 0 (basal diet), 0.5, 1.5, or 5 % (w/w) MSG for 92–96 days. Animals in both studies underwent clinical examinations, hematology and biochemistry tests, full necropsies, and histopathological examination. No toxicologically significant findings were reported in either study. In the 28-day study, there were no adverse effects observed at 5100 mg/kg bw/day (males) and 4800 mg/kg bw/day (females). In the 90-day study, a no-observed-adverse-effect level (NOAEL) was identified as the highest dose tested of 3170 mg/kg bw/day (males) and 3620 mg/kg bw/day (females) or more.
期刊介绍:
Regulatory Toxicology and Pharmacology publishes peer reviewed articles that involve the generation, evaluation, and interpretation of experimental animal and human data that are of direct importance and relevance for regulatory authorities with respect to toxicological and pharmacological regulations in society. All peer-reviewed articles that are published should be devoted to improve the protection of human health and environment. Reviews and discussions are welcomed that address legal and/or regulatory decisions with respect to risk assessment and management of toxicological and pharmacological compounds on a scientific basis. It addresses an international readership of scientists, risk assessors and managers, and other professionals active in the field of human and environmental health.
Types of peer-reviewed articles published:
-Original research articles of relevance for regulatory aspects covering aspects including, but not limited to:
1.Factors influencing human sensitivity
2.Exposure science related to risk assessment
3.Alternative toxicological test methods
4.Frameworks for evaluation and integration of data in regulatory evaluations
5.Harmonization across regulatory agencies
6.Read-across methods and evaluations
-Contemporary Reviews on policy related Research issues
-Letters to the Editor
-Guest Editorials (by Invitation)