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一水合 L-谷氨酸单钠盐的体外和体内遗传毒性研究。

In vitro and in vivo genotoxicity studies on monosodium L-glutamate monohydrate.

机构信息

Product Evaluation Group, Evaluation & Analysis Section, Research Institute for Bioscience Products & Fine Chemicals, Ajinomoto Co., Inc., 1-1, Suzuki-cho, Kawasaki-shi, Kanagawa, 210-8681, Japan.

Product Evaluation Group, Evaluation & Analysis Section, Research Institute for Bioscience Products & Fine Chemicals, Ajinomoto Co., Inc., 1-1, Suzuki-cho, Kawasaki-shi, Kanagawa, 210-8681, Japan.

出版信息

Regul Toxicol Pharmacol. 2019 Oct;107:104399. doi: 10.1016/j.yrtph.2019.05.024. Epub 2019 May 29.

Abstract

In response to the lack of authenticated mutagenicity/genotoxicity studies on MSG monohydrate, a series of genotoxicity studies conducted under GLP and according to globally accepted test guidelines (e.g., OECD) was performed. A bacterial reverse mutation test using Salmonella typhimurium (TA100, TA1535, TA98 and TA1537) and Escherichia coli (WP2 uvrA) at concentrations up to 5000 μg/plate, an in vitro chromosomal aberration test in CHL/IU cells at concentrations up to 10 mmol/L (1.9 mg/mL), a mouse lymphoma tk assay at concentrations up to 10 mmol/L (1.9 mg/mL), an in vitro micronucleus test in human peripheral blood lymphocytes at concentrations up to 10 mmol/L (1871 μg/mL), and an in vivo micronucleus test in bone marrow of rats that were gavaged with up to 2000 mg/kg bw were investigated. MSG monohydrate did not cause mutagenicity in any bacterial strain, did not induce chromosomal aberrations in CHL/IU cells or gene mutation in mouse lymphoma cells, was not clastogenic or aneugenic to human lymphocytes, and did not induce micronuclei in erythrocytes of rats when compared with vehicle controls. These results show that MSG is not mutagenic or genotoxic under the study conditions.

摘要

针对 MSG 一水合物缺乏经过验证的致突变性/遗传毒性研究,我们按照 GLP 进行了一系列遗传毒性研究,并遵循全球公认的测试指南(例如 OECD)。我们使用沙门氏菌(TA100、TA1535、TA98 和 TA1537)和大肠杆菌(WP2 uvrA)进行了细菌回复突变试验,浓度高达 5000μg/平板;在 CHL/IU 细胞中进行了体外染色体畸变试验,浓度高达 10mmol/L(1.9mg/mL);在浓度高达 10mmol/L(1.9mg/mL)的小鼠淋巴瘤 tk 试验中进行了试验;在人外周血淋巴细胞中进行了浓度高达 10mmol/L(1871μg/mL)的体外微核试验;在大鼠骨髓中进行了浓度高达 2000mg/kg bw 的体内微核试验。MSG 一水合物在任何细菌菌株中均未引起致突变性,在 CHL/IU 细胞中未引起染色体畸变或在小鼠淋巴瘤细胞中未引起基因突变,对人淋巴细胞无断裂作用或非整倍体作用,与载体对照相比,也未诱导大鼠红细胞微核形成。这些结果表明,在研究条件下,MSG 不具有致突变性或遗传毒性。

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