• Journal of Food Hygiene and Safety
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• v.39 no.1
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• pp.35-43
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• 2024

Numerous methods have been applied to assess the antibacterial effectiveness of hand hygiene products. However, the different results obtained through various evaluation methods have complicated our understanding of the real efficacy of the products. Few studies have compared test methods for assessing the efficacy of hand hygiene products. In particular, reports on ex vivo pig skin testing are limited. This study aimed to compare and characterize the methodologies applied for evaluating hand hygiene products, involving in vitro, ex vivo, and in vivo approaches, applicable to both leave-on sanitizers and wash-off products. Our further aim was to enhance the reliability of ex vivo test protocols by identifying influential factors. We performed an in vitro method (EN1276) and an in vivo test (EN1499 and ASTM2755) with at least 20 participants, against Serratia marcescens or Escherichia coli and Staphylococcus aureus. For the ex vivo experiment, we used pig skin squares prepared in the same way as those used in the in vivo test method and determined the optimal treated sample volumes for sanitizers and the amount of water required to wash off the product. The hand sanitizers showed at least a 5-log reduction in bacterial load in the in vitro test, while they showed little antibacterial activity in the in vivo and ex vivo tests, particularly those with a low alcohol content. For the hand wash products, the in vitro test was limited because of bubble formation or the high viscosity of the products and it showed low antibacterial activity of less than a 1-log reduction against E. coli. In contrast, significantly higher log reductions were observed in ex vivo and in vivo tests, consistently demonstrating these results across the two methods. Our findings revealed that the ex vivo and in vivo tests reflect the two different antibacterial mechanisms of leave-on and wash-off products. Our proposed optimized ex vivo test was more rapid and more precise than the in vitro test to evaluate antibacterial results.

• Biomolecules & Therapeutics
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• v.3 no.3
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• pp.242-244
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• 1995

In vitro cell culture system has been proposed as a promising alternative model to in vivo skin irritation test. These studies were performed to screen the cytotoxicity effects of surfactants using normal human skin fibroblasts. Cell membrane integrity assessed by the leakage of lactate dehydrogenase (LDH) and mitochondrial integrity by MTT [3-(4, 5-dimethylthiazol-2-yl)-2, 5-diphenyl tetrazolium bromides reduction test were affected in a dose dependent manner. The irritation potential of surfactants to human skin patch test, and the changes of capillary permeability by rabbit intradermal safety test were assessed as in vivo methods. Our results suggest that LDH leakage assay and MTT reduction test using cultured human fibroblasts could be predictive for the irritancy of various surfactants in human, and LDH assay is superior correlated with in vivo test (r=0.886) to MTT test with in vivotest (r=0.757).

• Journal of Applied Biological Chemistry
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• v.62 no.4
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• pp.355-359
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• 2019

In vivo micronucleus tests were performed to investigate the mutagenic potential of 4-butylaniline and N-butylaniline, which are used in dye intermediates and organic intermediates respectively. Groups of 5 male ICR mice were treated with vehicle or 4-butylaniline for 2 consecutive days by oral gavage at concentrations of 0 (control), 64, 160, 400, and 1000 mg/kg. Statistically significant and dose-dependent increases were found for micronuclei frequencies in male mice (p <0.05). These results suggest that 4-butylaniline can induce genetic effects in the micronuclei of male mouse bone marrow cells. Based on the positive results obtained in cytogenetic analyses of somatic cells in vivo, Globally Harmonized System of Classification and Labelling of Chemicals Category 2 was assigned. N-butylaniline was administered for 2 consecutive days by oral gavage to male ICR mice at dose of 0 (control), 64, 160, 400, and 800 mg/kg. N-butylaniline tested negative for micronuclei induction in mice, although N-butylaniline was associated with micronucleus induction at the highest dose. Based on the negative results obtained for cytogenetic analyses of somatic cells in vivo, "Not Classified" was assigned.

• Proceedings of the Korean Society of Toxicology Conference
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• 2002.11b
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• pp.146-146
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• 2002

The alkaline single cell gel electrophoresis (comet) assay was used to clarify in vitro and in vivo genotoxicity of 2-bromopropane (2-BP). For in vitro studies, fresh medium containing 2-BP (2.50, 1.00, 0.50, 0.25, 0.10, 0.05, 0.01 mM, and vehicle control) were added in human lymphocytes.(omitted)

• Advances in Traditional Medicine
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• v.5 no.1
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• pp.29-36
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• 2005

Polysaccharide hydrogels constitute a structurally diverse class of biological macromolecules with a wide range of physicochemical properties. They also constitute important members of the family of industrial water-soluble polymers. They find application in Pharmacy as binders, disintegrants, suspending, emulsifying and sustaining agents. According to the International Pharmaceutical Excipients Council (IPEC), an excipient must have an established safety profile. Hence, in the present study, in vitro cytotoxicity on Vero and HEp-2 cell lines, and in vivo acute toxicity in rats were carried out to establish the safety of polysaccharide hydrogels from the seeds of Plantago ovata and Ocimum basilicum. The in vitro cytotoxicity was determined by MTT and SRB assays. In the in vivo acute toxicity, the effects of three different doses of hydrogels (100, 200 and 400 mg/kg body weight) on food and water intake, body weight, biochemical and hematological parameters were studied. The results of in vitro did not show any cytotoxicity on both the cell lines used. In the in vivo acute toxicity, the hydrogels did not show any toxic symptoms in all three dose levels. This establishes the safety of the selected hydrogels. Hence, they can be used as excipients in pharmaceutical dosage forms.

• Food Science and Preservation
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• v.16 no.5
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• pp.782-788
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• 2009

The genotoxicological safety of gamma-irradiated egg white and yolk was examined to ensure that required safety parameters were met, and in an effort to further apply gamma-irradiation for improvement of the hygienic qualities of eggs. Egg white and yolk were irradiated at 20 kGy, much higher than the legally approved dose (less than 5 kGy), and possible genotoxicity was evaluated using in vitro and in vivo tests. The SOS chromotest employing Escherichia coli PQ37, and a chromosomal aberration test in cultured Chinese hamster lung (CHL) cells, were performed in vitro with or without metabolic activation (S9). An in vivo micronucleus development test was conducted using mouse bone marrow cells. Negative results were obtained in the SOS chromotest. The incidence of chromosomal aberration in CHL cells and the frequency of micronuclear developmentin mouse bone marrow cells treated with irradiated samples were not significantly different from those of non-irradiated controls. Thus, it may be concluded that up to 20 kGy of gamma irradiation applied to egg white and yolk did not show any genotoxic effects under our experimental conditions.

• Microbiology and Biotechnology Letters
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• v.49 no.1
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• pp.39-44
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• 2021

As consumption of healthy foods continues to garner remarkable public attention, ensuring probiotic safety has become a priority. In this study, the safety of Lactobacillus acidophilus IDCC 3302 was assessed in vitro and in vivo. L. acidophilus IDCC 3302 showed negative results for hemolytic and β-glucuronidase activities. The whole-genome analysis (WGA) revealed that L. acidophilus IDCC 3302 did not possess antibiotic resistance or virulence genes. The minimal inhibitory concentrations of L. acidophilus IDCC 3302 confirmed its safety concerning antibiotic resistance. Furthermore, L. acidophilus IDCC 3302 was demonstrated to be nontoxic in the oral toxicity test in rats. Therefore, the results suggested that L. acidophilus IDCC 3302 might be safe for human consumption.

• Journal of Life Science
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• v.24 no.7
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• pp.804-811
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• 2014

A micronucleus test of cyclohexanone has not yet been conducted. To classify the chemical hazard posed by cyclohexanone according to a globally harmonized system of classification and labeling of chemicals (GHS), we investigated its mutagenicity by micronucleus induction in ICR bone marrow cells of 7-weeek-old male mice. The mice were administered three dosages of the chemical for 24 hr via the oral route. After 24 hr, the mice were sacrificed, and their bone marrow cells were prepared for smearing slides. Based on counts of micronucleated polychromatic erythrocytes (MNPCEs) of 2,000 polychromatic erythrocytes, cyclohexanone did not inhibit bone marrow cell proliferation in any of the treated groups, but it resulted in micronucleus induction. According to the results of the mammalian bone marrow micronucleus test, this chemical is mutagenic and classified as category 2 in the GHS.

• Journal of the Korean Society of Food Science and Nutrition
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• v.33 no.7
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• pp.1192-1200
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• 2004

Gamma irradiations at 5 or 10 kGy were applied to salted and fermented anchovy sauce, for improving the hygiene Quality and evaluating the genotoxicological safety. In vitro genotoxicological safety of irradiated sauces was evaluated by Salmonella Typhimurium (TA98, TA100, TAI535 and TAI537) and E. coli WP2 uvrA, reversion assay, SOS chromotest (Escherichia coli PQ37), and chromosome aberration test (Chinese hamster lung fibroblast cells) in the absence or presence of an exogenous metabolizing system (S9 mix). The gamma-irradiated samples were not significantly different from nonirradiated-control for three in vitro tests (p＜0.05). ：In vivo micronucleus test using ICR mice (male) was not significantly different from the control at p＜0.05. The salted and fermented anchovy sauce exposed to 5 or 10 kGy-gamma ray revealed negative results in these three in vitro mutagenetic tests and in vivo micronucleus test upto 50,000 $\mu$g/plate, respectively. The results indicated that 5 or 10 kGy gamma-irradiated salted and fermented anchovy sauces did not show any mutagenicity.

• Safety and Health at Work
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• v.2 no.1
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• pp.34-38
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• 2011

Objectives: The antimicrobial activity of silver nanoparticles has resulted in their widespread use in many consumer products. Yet, despite their many advantages, it is also important to determine whether silver nanoparticles may represent a hazard to the environment and human health. Methods: Thus, to evaluate the genotoxic potential of silver nanoparticles, in vivo genotoxicity testing (OECD 474, in vivo micronuclei test) was conducted after exposing male and female Sprague-Dawley rats to silver nanoparticles by inhalation for 90 days according to OECD test guideline 413 (Subchronic Inhalation Toxicity: 90 Day Study) with a good laboratory practice system. The rats were exposed to silver nanoparticles (18 nm diameter) at concentrations of $0.7\;{\times}\;10^6$ particles/$cm^3$ (low dose), $1.4\;{\times}\;10^6$ particles/$cm^3$ (middle dose), and $2.9\;{\times}\;10^6$ particles/$cm^3$ (high dose) for 6 hr/day in an inhalation chamber for 90 days. The rats were killed 24 hr after the last administration, then the femurs were removed and the bone marrow collected and evaluated for micronucleus induction. Results: There were no statistically significant differences in the micronucleated polychromatic erythrocytes or in the ratio of polychromatic erythrocytes among the total erythrocytes after silver nanoparticle exposure when compared with the control. Conclusion: The present results suggest that exposure to silver nanoparticles by inhalation for 90 days does not induce genetic toxicity in male and female rat bone marrow in vivo.