• The Journal of Internal Korean Medicine
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• v.27 no.1
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• pp.102-113
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• 2006

Objectives & Methods : To obtain the 50% lethal dose(LD50), approximated lethal dose(ALD) and approximated target organs of 'Mahwangyounpae-tang' for further study into such things as repeated dose toxicity, genotoxicity and reproductive toxicity, single dose toxicity was tested in male SD rats according to KFDA Guideline 1999-61[KFDA, 1999] at dosage levels of 2,000, 1,000, 500, 250 and 125 mg/kg/$10m{\ell}$. In this study, mortalities, clinical signs, body weight changes and body weight gains, gross findings and weight of principal organs were detected during and/or after 14 days of single dosing. Results & Conclusions : After 2 or 3 days of dosing, 1 or 2 animals in 2,000 mg/kg-dosing groups died. Excitation and leaping response were observed as test article-treatment related clinical signs. These abnormal signs were restricted to 2,000 and 1,000 mg/kg-dosing groups and survivors recovered to normal within 3 or 4 days after dosing. Significant decrease in body weight were observed in some periods of observation in 2,000 and 1,000 mg/kg-dosing group, from 1 days after dosing compared to those of vehicle control group. Significantly diminished body weight gains were observed in observation periods in 2,000 and 1,000 mg/kg-dosing group compared to those of vehicle control group. Hypertrophy and hemorrhage of heart and decoloration of kidney were observed as test article-treatment related gross findings. These abnormal findings were restricted to 2,000 and 1,000 mg/kg-dosing groups. A significant increase of absolute and relative heart and kidney weight were demonstrated in 2,000 mg/kg-dosing groups. The value for LD50 found in this study was 2,218.57 mg/kg. ALD in this study was 2,000 mg/kg, and the target organs are considered to be the heart and the kidney.

• Journal of Physiology & Pathology in Korean Medicine
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• v.20 no.2
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• pp.442-448
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• 2006

To obtain the 50% lethal dose (LD50), approximated lethal dose (ALD) and approximated target organs of 'Mahwangyounpae-tang' for further study like repeat dose toxicity, genotoxicity and reproductive toxicity, single dose toxicity was tested in male ICR mouse according to KFDA Guideline 1999-61 [KFDA, 1999] at a dosage level of 2,000, 1,000, 500, 250 and $125\;mg/kg/10m{\ell}$. In this study, mortalities, clinical signs, body weight changes and body weight gains, gross findings and weight of principal organs were detected during and/or after 14 days of single dosing. After 2 or 3 days of dosing, 1 or 2 animals in 2,000 and 1,000 mg/kg-dosing groups were died. Excitation and leaping response were observed as test article-treatment related clinical signs. These abnormal signs were restricted to 2,000 and 1,000 mg/kg-dosing groups and they were recovered to normal within 4 days after dosing in case of survivors. A significant decrease of body weight were observed in some periods of observation in 2,000 and 1,000 mg/kg-dosing group from 1 days after dosing compared to those of vehicle control group. A significant decrease of body weight gains were observed in observation periods in 2,000 and 1,000 mg/kg-dosing group compared to those of vehicle control group. Hypertrophy of heart and decoloration of kidney were observed as test article-treatment related gross findings. These abnormal findings were restricted to 2,000 and 1,000 mg/kg-dosing groups. A significant increase of absolute and relative heart and kidney weight were demonstrated in 2,000 mg/kg-dosing groups. LD50 in this study was detected as 2,242.42 mg/kg. ALD in this study was detected as 1,000 mg/kg and the target organ was considered as the heart and kidney.

• The Korean Journal of Food And Nutrition
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• v.26 no.3
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• pp.383-390
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• 2013

Mistlero C was shown to be non-genotoxic in a series of genotoxicity tests, including a bacterial reverse mutation test and a combined in vivo mammalian erythrocyte micronucleus test. In a bacterial reverse mutation assay, no significant increases in the number of revertant colonies, compared to the negative control, was detected in $5,000{\mu}g/plate$ of Mistlero C. In addition, with Mistlero C, no changes were shown in the number of micronucleated polychromatic erythrocytes (MNPCE) among 2,000 polychromatic erythrocytes compared to the negative control. Mistlero C was administered orally in rats to investigate acute toxicity. The $LD_{50}$ values in rats were above 2,000 mg/kg. In a repeated dose, 13-week, oral toxicity study conducted in rats, no compound-related adverse effects were shown at doses of Mistlero C of up to 1,000 mg/kg body weight/day. The results of these studies support the safe use of Mistlero C in food for human consumption.

• Food Science of Animal Resources
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• v.30 no.1
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• pp.141-147
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• 2010

This study evaluated the antimicrobial effects of retort process and gamma irradiation on reduction of total bacterial populations in spicy chicken sauce, which is served on top of the steamed rice. Commercial spicy chicken sauce was treated with retort and gamma ray at 0, 1, 3, 5, and 10 kGy. Total aerobic bacterial populations were then enumerated on plate count agar and isolated bacteria from the test samples were identified using PCR analysis. Moreover, gamma ray sensitivity of identified bacteria was evaluated by $D_{10}$ values, and genotoxicity of gamma-irradiated samples was examined. Gamma irradiation at 3 kGy reduced total aerobic bacterial cell counts in spicy chicken sauce below detection limit, but total aerobic bacterial cell counts in test samples treated with retort were 2.1 log CFU/g. Identified bacteria from the samples were Bacillus subtilis, B. amyloiquefaciense, and B. pumils, and the $D_{10}$ values for B. subtilis and B. cereus were 0.39 ($R^2\;=\;0.921$) and 0.28 log CFU/g ($R^2\;=\;0.904$), respectively. The SOS chromotest showed that the gamma-irradiated spicy chicken sauce did not cause mutagenicity. These results indicate that gamma irradiation of spicy chicken sauce could be useful in ensuring microbial safety.

• Journal of the Korean Society of Food Science and Nutrition
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• v.37 no.7
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• pp.853-857
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• 2008

To assess the clastogenic effects of the diglyceride preparation containing conjugated linoleic acid (DG+CLA) in vivo micronucleus test was performed using ICR mice. Each of the groups consisted of three doses of DG+CLA (500, 1,000 and 2,000 mg/kg, p.o.), Mitomycin C (positive control, 2 mg/kg, i.p.) and negative control (olive oil, 10 mL/kg, p.o.). A slide preparation was made at 24 hours after 1st treatment with DG+CLA. As a result of counting the icronucleated polychromatic erythrocyte (MNPCE) of 2,000 polychromatic erythrocyte (PCE), the number of aberrant cells was not increased in any of the three doses of DG+CLA orally administered. There was no clinical sign connected with administration of DG+CLA. These results indicate that DG+CLA is not capable of inducing micronuclei in vivo mice cells and thus has no genotoxicity in micronucleus.

• Toxicological Research
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• v.24 no.1
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• pp.37-44
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• 2008

The in vitro cell transformation assays (CTA) were performed using BALB/3T3 murine fibroblasts and HaCaT human keratinocytes in order to evaluate concordance between both in vitro CTAs and carcinogenicity with compounds differing in their genotoxic and carcinogenic potential. Six test articles were evaluated, two each from three classes of compounds: genotoxic carcinogens (2-amino-5-nitrophenol and 4-nitroquinoline-N-oxide), genotoxic noncarcinogens (8-hydroxyquinoline and benzyl alcohol), and nongenotoxic carcinogens (methyl carbamate and N-nitrosodiphenylamine). Any foci of size $\geq$2 mm regardless of invasiveness and piling was scored as positive in CTA with BALB/3T3. As expected, four carcinogens regardless of their genotoxicity had positive outcomes in two-stage CTA using BALB/3T3 cells. However, of the two genotoxic noncarcinogens, benzyl alcohol was positive CTA finding. We concluded that, of the 6 chemicals tested, the sensitivity for BALB/3T3 system was reasonably high, being 100%. The respective specificity for BALB/3T3 assay was 50%. We also investigated the correlation between results of BALB/3T3 assay and results from HaCaT assay in order to develop a reliable human cell transformation assay. However, evaluation of staining at later time points beyond the confluency stage did not yield further assessable data because most of HaCaT cells were detached after $2{\sim}3$ days of confluency. Thus, after test article treatment, HaCaT cells were split before massive cell death began. In this modified protocol for this HaCaT system, growing attached colonies were counted instead of transformed foci 3 weeks since last subculture. Compared to BALB/3T3 assay, HaCaT assay showed moderate low sensitivity and high specificity. Despite these differences in specificity and sensitivity, both cell systems did exhibit same good concordance between in vitro CTA and rodent carcinogenicity findings (overall 83% concordant results). At present the major weakness of these in vitro CTA is lack of validation for regulatory acceptance and use. Thus, more controlled studies will be needed in order to be better able to assess and quantitatively estimate in vitro CTA data.

• Journal of Food Hygiene and Safety
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• v.32 no.3
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• pp.228-233
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• 2017

The aim of the current study was to examine genotoxicological safety of purified bee venom (Apis mellifera L.) The bacterial reverse mutation in Salmonella typhimurium (TA100, TA1535, TA98, and TA1537) and Escherichia coli (WP2 uvrA) were evaluated with purified bee venom at concentrations of 0, 1.5, 5, 15, 50, 150, and $500{\mu}g/plate$. Purified bee venom was negative in Ames test with both in the presence and absence of rat liver microsomal enzyme. According to these results, we concluded that purified bee venom did not cause bacterial reverse mutation. The safety of the purified bee venom at practical doses needs to be further evaluated in in vivo genotoxicity assays.

• Journal of the Korean Society of Food Science and Nutrition
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• v.43 no.10
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• pp.1588-1593
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• 2014

This study evaluated the genotoxic effects of 30 kGy of X-ray irradiation to four foods (chicken, egg powder, dried green onion, and black pepper). In bacterial reversion assay with Salmonella Typhimurium TA98, TA100, TA1535, and TA1537, the X-ray irradiated foods did not show a significantly increased number of revertant colonies in the presence or absence of the S9 metabolic activation system. In chromosomal aberration tests with Chinese hamster ovary (CHO) cells, the X-ray irradiated foods showed no increase in the frequency of chromosomal aberrations. In in vivo mouse micronucleus assay, the X-ray irradiated foods did not show any increase in the frequency of polychromatic erythrocytes with micronuclei. These results indicate that 30 kGy of X-ray irradiation to four foods (chicken, egg powder, dried green onion, and black pepper) showed no genotoxic effects under these experimental conditions.

• Journal of the Society of Cosmetic Scientists of Korea
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• v.31 no.3 s.52
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• pp.245-251
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• 2005

Safety is one of the key issue in the regulation of cosmetics. Cosmetic Act deals with it in Korea. The guidance for the testing cosmetic ingredients and their safety evaluation are prepared by Korea Food and Drug Administration. Ultraviolet radiation could Induce skin damage, edema, erythema, photoaging, immune dysfunction and skin cancer. Ultraviolet radiation is classified as Group 2A(probably carcinogenic to humans) by International Agenry for Reaserch on Cancer(IARC). The in vitro methodologies for evaluating the toxic potential of ingredients reported in the literature have not yet been sufficiently validated for use in areas other than the study for mutagenicity/genotoxicity, for pre-screening for severe irritancy, for screening of phototoxicity and for evaluating the percutaneous absorption. The 3T3 neutral red uptake photoxicity test (3T3 NRU PT) was accepted as OECD toxicity guideline in 2002. The 3T3 NRU PT is an in vitro method based on a comparison of the cytotoxicitv of a chemical when tested in the presence and in the absence of exposure to a non-cytotoxic dose of UVA/visible light.

• Korean Journal of Microbiology
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• v.53 no.1
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• pp.20-28
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• 2017

Physical sterilization methods using ultraviolet radiation and ionizing radiation such as gamma ray and electron beam are applied in various industry fields due to disinfection effects and economic efficiency but may also cause microbial mutation. In this research, Salmonella enterica and Escherichia coli strains were treated with ionizing and ultraviolet radiation and their survival rate, mutation rate, and DNA damage were studied to evaluate the genetic safety. The survival rate of the strains decreased drastically as the irradiation dose of ultraviolet ray, gamma ray, and electron beam increased, and over 90% of the strain was exterminated at a dosage of $0.40{\sim}25.06mJ/cm^3$, 0.11~0.22 kGy, 0.14~0.53 kGy respectively. In SOS / umu-test, genotoxicity causing DNA damage was identified in all samples. In Ames test, back-mutation rate increased to $3.82{\times}10^{-4}$ and $9.84{\times}10^{-6}$ respectively when exposed to ultraviolet ray and gamma ray. At exposure to ultraviolet ray, gamma ray, and electron beam with dosage of over 99.99% extinction rate of S. enterica TA100, back-mutation rate increased 347 times, 220 times, 0.6 times respectively to the spontaneous back-mutation rate. Rifampicin resistance mutation rate of E. coli CSH100 exposed to ultraviolet ray, gamma ray, and electron beam was $2.46{\times}10^{-6}$, $1.66{\times}10^{-6}$, $4.12{\times}10^{-7}$ respectively. Therefore, gamma radiation is effective in microorganism control from the perspective of disinfection and electron beam has the advantage of sterilizing with little DNA damage and bacterial mutation.