• The Korea Journal of Herbology
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• v.22 no.4
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• pp.287-300
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• 2007

Objectives : The genotoxicity of extract of "Hyeonggaeyeongyotang", a polyherbal formula has been used as a tonic agents in oriental medicine was tested. Methods : Extract of "Hyeonggaeyeongyotang" was tested by In Vitro Chromosome Aberration Test, Bacterial Reverse Mutation Assay and Micronucleus test according to OECD Guidelines and KFDA Guidelines [2005-60]. Results : The obtained results were as follows: 1. Chromosome Aberration Test: No significant changes in the number of aberrant metaphases having structural and number of aberrations were detected in all concentrations of "Hyeonggaeyeongyotang" extracts treated in this study. 2. Bacterial Reverse Mutation Assay: No significant increases in the number of revertant colonies compared to its negative control were detected in all concentrations of "Hyeonggaeyeongyotang" extracts treated in this study against all 5 strains except for $50{\mu}g/ml$ treated group where significantly decreases in colony numbers were detected agains all five strains used in this study as pharmacological effects not genotoxicity. 3. Micronucleus test: No significant changes in the number of micronucleated polychromatic erythrocytes among 2000 polychromatic erythrocytes compared to negative control were detected in all "Hyeonggaeyeongyotang" extracts-dosing groups tested. Conclusions : From above-mentioned results, it is concluded that "Hyeonggaeyeongyotang" extracts have not any genotoxicity against In Vitro Chromosome Aberration Test, Bacterial Reverse Mutation Assay and Micronucleus test.

• Journal of Food Hygiene and Safety
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• v.20 no.3
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• pp.175-178
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• 2005

Clean Natural is a new disinfectant of which main components are propolis and wood vinegar from Quercus mongolica. To evauate the bacterial reverse mutation of Clean Watural, the in vitro Ames test using Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 were performed with clean natural at the concentrations 0, 5, 2.5, and 1.25 mg/ml/plate. Clean Natural was negative in Ames test with Salmonella typhymuyium with and without rat liver microsomal enzyme (S-9 fraction). These results indicate that Clean Watural does not cause bacterial reverse mutation.

• Journal of Food Hygiene and Safety
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• v.19 no.4
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• pp.193-197
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• 2004

To evaluate the bacterial reverse mutation of wild ginseng culture extract, the in vitro Ames test using Salmonella typhimurium (TA100, TA1,535, TA98, TA1,537) and Escherichia coli (WP2 uvrA) were performed with wild ginseng extract at the concentrations 0, 1.6, 8, 40, 200, 1,000, 2,500 and $5,000{\mu}g/ml/plate$. Wild ginseng culture extract was negative in Ames test with both Salmonella typhimurium or Escherichia coli with and without rat liver microsomal enzyme (S-9 fraction). According to these results, we concluded that wild ginseng culture extract did not cause bacterial reverse mutation.

• Journal of Dairy Science and Biotechnology
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• v.34 no.2
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• pp.137-144
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• 2016

The ultimate research goal of the current study was a development of hydrolyzed whey protein powder (7%-GNANA) manufactured with normal content of sialic acid, a marker compound, that is naturally occurring at 7% concentration in GMP obtained from the milk protein. GMP is a safe food, used worldwide in infant and baby foods, etc. The test substance was prepared using (7% sialic acid containing) GMP as a raw material, and then using alcalase, an enzyme approved as a food additive, after separation of sialic acid with 100% efficiency and 7%-GNANA (containing 7% sialic acid and protein; product name: HELICOBACTROL-7) provided by MEDINUTROL Inc. (Korea). Bacterial reverse mutation (Ames) test was conducted in accordance with GLP Guideline using the test substance specified above. To identify its mutagenic potential against microorganisms, histidine auxotrophic strains of Salmonella Typhimurium, TA98, TA100, TA1535, and TA1537, and tryptophan auxotrophic strain of Escherichia coli, WP2uvrA, were used. The bacterial reverse mutation (Ames) test was performed by dividing the test substances into five different concentration groups (0, 61.7, 185, 556, 1,670, $5,000{\mu}g/plate$). Results of this experiment did not reveal repetitive increase of colony generating values or positive criteria for reverse mutagenicity for any concentration of test substances in any of the five strains, regardless of the presence of a metabolic activation system, and no dose-dependency was identified. In conclusion, the safety of 7%-GNANA test substance was verified by bacterial reverse mutation test conducted before registration of 7%-GNANA as a food additive.

• Journal of Dairy Science and Biotechnology
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• v.34 no.2
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• pp.91-98
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• 2016

The goal of this study was to develop hydrolyzed whey protein powder (23%-GNANA) manufactured with high content of sialic acid, a marker compound that is usually present at 7% concentration in GMP obtained from the milk protein. It is a safe food, used worldwide in infant and baby foods, etc. The test substance was prepared using (7% sialic acid containing) GMP as a raw material. Alcalase, an enzyme approved as a food additive, was used after separating sialic acid, with 100% efficiency, and 23%-GNANA (composed of 23% sialic acid and protein; product name: HELICOBACTROL-23), provided by MEDINUTROL Inc. (Korea), manufactured to have high (23%) content through ethanol soaking and enrichment. Bacterial reverse mutation (Ames) test was conducted in accordance with the GLP Guideline using the test substance specified above. To detect its mutagenicity potential in microorganisms, histidine auxotrophic strains of Salmonella typhimurium, TA98, TA100, TA1535, and TA1537, and tryptophan auxotrophic Escherichia coli strain, WP2uvrA, were used. The bacterial reverse mutation (Ames) test was performed using five concentrations of the test substances (0, 61.7, 185, 556, 1,670, $5,000{\mu}g/plate$). The evaluation did not reveal repetitive increase of colony generating values and positive criteria for reverse mutagenicity for any tested concentration in the five strains regardless of the presence of metabolic activation system, and no dose-dependency. In conclusion, the safety of 23%-GNANA test substance was verified by the bacterial reverse mutation test conducted before registration of 23%-GNANA as a food additive.

• Toxicological Research
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• v.29 no.3
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• pp.217-219
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• 2013

Hypertension is a serious health problem due to high frequency and concomitant other diseases including cardiovascular and renal dysfunction. Olmesartan cilexetil is a new antihypertensive drug associated with angiotensin II receptor antagonist. This study was conducted to evaluate the mutagenicity of olmesartan cilexetil by bacterial reverse mutation test using Salmonella typhimurium (TA100, TA1535, TA98, and TA1537) and Escherichia coli (WP2 uvrA). At the concentrations of 0, 62, 185, 556, 1667, and 5000 ${\mu}g$/plate, olmesartan cilexetil was negative in both Salmonella typhimurium and Escherichia coli regardless of presence or absence of metabolic activation system (S9 mix). These results demonstrate that olmesartan cilexetil does not induce bacterial reverse mutation.

• Toxicological Research
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• v.22 no.2
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• pp.145-151
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• 2006

We have investigated the genotoxicity of STB-HO-BM using in vitro and in vivo system such as Ames reverse mutation test, chromosomal aberration test and micronucleus test. in Ames reverse mutation test, STB-HO-BM treatment at the dose range up to 5,000 ug/plate did not induce mutagenicity in Salmonella typhimurium TA98, TA100, TA102, TA1535, TA 1537 and in Escherichia coli WP2 uvrA with and without metabolic activation. Any significant aberration wasn't observed in chinese hamster lung (CHL) fibroblast cells treated with STB-HO-BM at the concentration of 12.5, 2.5, 5 mg/ml both in the absense and presence of metabolic activation system. In mouse micrnucleus test, no significant increase in the occurrence of micronucleated polychromatic erythrocytes was observed in ICR male mice orally administered with STB-HO-BM at the doses of 0.5, 1.0, 2.0 g/kg. These results indicate that STB-HO-BM has no mutagenic potential under the condition in this study.

• Journal of Food Hygiene and Safety
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• v.27 no.2
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• pp.141-145
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• 2012

Zizyphi spinosi semen (Z. spinosi) has been used in traditional Chinese medicine for the treatment of rheumatoid arthritis and wounds. However, toxicity in high doses was often observed due to the presence of alkaloids. This study was conducted to investigate the potential genotoxicity of Z. spinosi in vitro and in vivo. This was examined by the Bacterial reverse mutation (Ames) test using Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Escherichia coli WP2uvrA, Chromosomal aberration was investigated using Chinese hamster lung cells and the micronucleus test using mice. Z. Spinosi did not induce mutagenicity in the Ames test, and it did not produce chromosomal aberration in Chinese hamster lung cells with and without metabolic activation, nor in the micronucleated polychromatic erythrocytes in the bone marrow cells in mice. Based on these results, it is concluded that Z. spinosi does not have mutagenic potential under the conditions examined in each study.

• The Journal of Korean Medicine
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• v.41 no.3
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• pp.55-65
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• 2020

Objectives: This study aimed to evaluate the toxicity of CP pharmacopunture using bacterial reverse mutation test. Methods: To determine the mutagenic potential of CP pharmacopunture, histidine requiring Salmonella typhimurium (TA98, TA100, TA1535, and TA1537) and tryptophan requiring Escherichia coli (WP2uvrA, pKM101) strains were used. The negative (normal saline solution) and positive (Sodium azide, 2-Nitrofluorene, 2-Aminoanthracene, 9-Aminoacridine, and 4-Nitroquinoline N-oxide) control groups were used. To determine the dose levels of the main study, a dose range-finding study was conducted. Results: As a results of the dose range-finding study, the growth inhibition by CP pharmacopunture was not evident at any dose levels in the absence and presence of metabolic activation. As a results of the main study, the mean number of revertant colonies was less than twice when compared to the negative control values at all dose levels of the CP pharmacopuncture in the presence and absence of metabolic activation, showing no dose-related increase. In the positive control group, the number of revertant colonies was markedly increased by more than twice when compared to the negative control group. Conclusion: According to the results of this study, CP pharmacopunture did not show any signs of mutagenic potential.

• Toxicological Research
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• v.18 no.4
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• pp.349-354
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• 2002

Inflammatory bowel disease (IBD) is a multifactorial disorder with unknown etiology and pathogenesis. Eupatilin, a kind of flavonoids, has been known to be effective for chronic diarrhea in Korea. In this study, we have investigated the genotoxicity of DA-6034, a new synthetic derivative of Eupatilin, wing in vitro and in viuo system such as Ames reverse mutation test, chromosomal aberration test and micronucleus test. in Ames reverse mutation test, DA-6034 treatment at the dose range up to 5,000 $\mu\textrm{g}$/ plate did not induced mutagenicity in Salmonella typhimurium TA98, TA100, TA102, TA1535, TA1537 with and without metabolic activation. Any significant aberration wasn't observed in chinese hamster lung(CHL) fibroblast cells treated with DA-6034 at the concentration of 5, 2.5, 1.25 mg/ml both in the absence and presence of metabolic activation system. In mouse micronucleus test, no significant increase in the occurrence of micronucleated polychromatic erythrocytes was observed in ICR male mice orally administered with DA-6034 of the doses of 2.0, 1.0, 0.5 g/kg. These results indicate that DA-6034 has no mutagenic potential under the condition in this study.