• The Korea Journal of Herbology
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• v.25 no.2
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• pp.137-144
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• 2010

Objectives : We investigated genetic toxicity of HMCO5 using the Micronucleus Test in bone marrow cells of mice and Bacterial Reverse Mutation Assay in plate incorporation method according to OECD Guidelines and KFDA Guidelines. Methods : 1. Micronucleus test: The male rats were divided into 5 groups, respectively; G(1), treated with distilled water: G(2), treated with 1250mg/kg HMC05: G(3), treated with 2500mg/kg HMC05, G(4), treated with 5,000mg/kg HMC05; G(5), treated with Cyclophosphamide $H_2O$. Sterilized distilled water and HMC05 were administered for two consecutive days. Cyclophosphamide $H_2O$ was administered once on the day of 2nd administration. 2. Bacterial Reverse Mutation Aassay: Experimental groups were divided into two groups: with S-9mix(+S) or without S-9mix(-S). Each group treated with sterilized distilled water only, HMCO5(62, 185, 556, 1,667, $5,000{\mu}g$/plate) and, positive vehicles(Sodium azide, 2-Aminoanthracene, 4-Nitroquinoline N-oxide, ICR 191), respectively. Results : HMC05 did not show any changes in the number of micronucleated polychromatic erythrocytes(MNPCE) among 200 polychromatic erythrocytes compare to negative control. However, there were significant (p<0.01) increase with CPA in MNPCE. In Bacterial Reverse Mutation Aassay, no significant increases in the number of revertant colonies compared to (삭제) negative control were detected in all concentrations of HMC05. Conclusions : These results indicate that HMC05 did not show any genotoxicity against in Micronucleus test and Bacterial Reverse Mutation Aassay.

• The Journal of Korean Medicine
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• v.29 no.3
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• pp.1-10
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• 2008

Objectives: This study was to assess the toxicity of Sipjeondaebo-tang by bacterial reverse mutation test. Methods: In this study, to evaluate the bacterial reverse mutation of Sipjeondaebo-tang water-extract, the in vitro Ames test using Salmonella typhimurium (TA98, TA100, TA1,535, TA1,537) and Escherichia coli(WP2uvrA) were performed with Sipjeondaebo-tang water extract at the concentrations 0, 312, 625, 1250, 2500 and 5000 ${\mu}g/plate$. Results: Sipjeondaebo-tang water extract was negative in Ames test with both Salmonella typhimurium or Escherichia coli with and without rat liver microsomal enzyme (S9- fraction and S+ fraction). Conclusions: According to these results, we concluded that a Sipjeondaebo-tang water extract did not cause bacterial reverse mutation.

• Journal of Ginseng Research
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• v.41 no.4
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• pp.595-601
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• 2017

Background: Red ginseng oil (RGO) is produced by supercritical $CO_2$ extraction of secondary products derived from Korean Red Ginseng extract. As the use of RGO has increased, product safety concerns have become more important. Methods: In the present study, the subacute oral toxicity and bacterial reverse mutagenicity of RGO were evaluated. Sprague-Dawley rats were orally administered with RGO for 28 d by gavage. Daily RGO dose concentrations were 0 mg/kg body weight (bw), 500 mg/kg bw, 1,000 mg/kg bw, or 2,000 mg/kg bw per day. Bacterial reverse mutation tests included five bacterial strains (Escherichia coli WP2 and Salmonella typhimurium TA98, TA100, TA1535, and TA1537), which were used in the presence or absence of metabolic activation. The plated incorporation method for mutation test was used with RGO concentrations ranging from $312.5{\mu}g$ to $5,000{\mu}g$ per plate. Results: The subacute oral toxicity test results did not reveal any marked changes in clinical characteristics. There were no toxicological changes related to RGO administration in hematological and serum biochemical characteristics in either control or treatment animals. Furthermore, no gross or histopathological changes related to RGO treatment were observed. The bacterial reverse mutation test results did not reveal, at any RGO concentration level and in all bacterial strains, any increase in the number of revertant colonies in the RGO treatment group compared to that in the negative control group. Conclusion: The no-observed-adverse-effect level of RGO is greater than 2,000 mg/kg bw and RGO did not induce genotoxicity related to bacterial reverse mutations.

• Herbal Formula Science
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• v.14 no.1
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• pp.141-167
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• 2006

The genotoxicity of water extract of Bojungikkeehapdaechilki-tang was tested by In Vitro Chromosome Aberration Test. Bacterial Reverse Mutation Assay and Micronucleus test according to OECD Guidelines and KFDA Guidelines. The obtained results were as follows : 1. Chromosome Aberration Test: In Vitro Chromosome Aberration Test of Bojungikkeehapdaechilki-tang extracts was carried out using cultured Chinese hamster lung cells in the presence and absence of metabolic activation system(S-9 mix). No significant changes in the number of aberrant metaphases having structural and number of aberrations were detected in Bojungikkeehapdaechilki-tang extracts treated groups. 2. Bacterial Reveres Mutation Assay: Bojungikkeehapdaechilki-tang extracts was evaluated for its potential to induce reverse mutation in the histidine auxotroph strains of Salmonella typhimurium such as TA100, TA1535, TA98 and TAl537 and the tryptophan auxotroph strain of Escherichia coli WP2 uvrA. No significant changes in the number of revertant colonies compared to its negative control were detected in Bojungikkeehapdaechilki-tang extracts treated groups against all 5 strains. 3. Micronucleus test: Micronucleus test of Bojungikkeehapdaechilki-tang extracts were performed using specific pathogen free 7-week old male ICR mouse. No significant changes in the number of micronucleated polychromatic erythrocytes among 2000 polychromatic erythrocytes compared to negative control were detected in all Bojungikkeehapdaechilki-tang extracts treated groups. In summarized above-mentioned results, it is concluded that Bojungikkeehapdaechilki-tang extracts have not genotoxicity against In Vitro Chromosome Aberration Test, Bacterial Reverse Mutation Assay and Micronucleus test.

• 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.

• 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 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.35 no.3
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• pp.215-224
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• 2019

As various populations are rapidly becoming an aging society worldwide and interest in health issues has increased, demand for functional foods including herbal products has increased markedly to maintain a healthy state which has led to safety issues about their intake as an inevitable result. The objective of this study was to identify the safety profile of a Korean red ginseng and Salvia plebeia R. Br. extract mixture (KGC-03-PS) which is a valuable ingredient that can be used as a functional food. In the present study, the subacute oral toxicity and bacterial reverse mutagenicity of KGC-03-PS were evaluated. Sprague Dawley rats were administered KGC-03-PS orally for 28 days by gavage. Daily KGC-03-PS dose concentrations were 0, 500, 1,000, or 2,000 mg/kg body weight (bw) per day. Bacterial reverse mutation test with KGC-03-PS dose levels ranging from 312.5 to $5,000{\mu}g/plate$ was carried out by OECD test guideline No. 471. Five bacterial strains (Salmonella typhimurium TA98, TA100, TA1535, TA1537, and Escherichia coli WP2) were tested in the presence or absence of metabolic activation by plate incorporation method. There were no toxicological effects related with test substance in the clinical evaluation of subacute oral toxicity test including clinical signs, body weight, and food consumption. Moreover, no toxicological changes related to KGC-03-PS were observed in the hematological and serum biochemical characteristics as well as in the pathological examinations, which included organ weight measurements and in the gross- or histopathological findings. KGC-03-PS did not induce an increase in the number of revertant colonies in all bacterial strains of the bacterial reverse mutation test. The no-observed-adverse-effect level of KGC-03-PS is greater than 2,000 mg/kg bw/day, and KGC-03-PS did not induce genotoxicity related to bacterial reverse mutations under the conditions used in this 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.