• The Korean Journal of Pesticide Science
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• v.14 no.4
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• pp.490-498
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• 2010

Isotianil is a fungicide which has prevention effects against rice blast disease. In order to register this new pesticide, the series of toxicity data on animal testing were reviewed to evaluate its hazards to consumers and to determine its acceptable daily intake. Isotianil was almost excreted by urine and feces. It has low acute oral toxicity while has no skin toxicity and ocular irritation. Its skin sensitization was evaluated as slight. Genotoxicity of parent compound and metabolite was negligible. Chronic toxicity tests on rats and dogs showed changes of hematology, clinical biochemistry and liver weight. It had no reproductive and teratogenic effects. The estimation of Acceptable Daily Intake(ADI) is based on the lowest no-observed adverse effect level (NOAEL). The lowest NOAEL of 2.83 mg/kg bw/day was found in the twelve-months rats study. The NOAEL was based on increased liver weight and treatment-related effect on clinica chemistry finding at the nest higher dose level of 2.83 mg/kg bw/day. Therefore, it is considered appropriated to apply an uncertainty factor of 100 to the NOAEL 2.83 mg/kg bw/day from the rat study, resulting in an ADI of 0.028 mg/kg bw/day.

• Safety and Health at Work
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• v.6 no.3
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• pp.256-262
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• 2015

Background: Heart attack is the most common cause of line-of-duty death in the fire service. Daily aspirin therapy is a preventative measure used to reduce the morbidity of heart attacks but may decrease the ability to dissipate heat by reducing skin blood flow. Methods: In this double-blind, placebo-controlled, crossover study, firefighters were randomized to receive 14 days of therapy (81-mg aspirin or placebo) before performing treadmill exercise in thermal-protective clothing in a hot room [$38.8{\pm}2.1^{\circ}C$, $24.9{\pm}9.1%$ relative humidity (RH)]. Three weeks without therapy was provided before crossing to the other arm. Firefighters completed a baseline skin blood-flow assessment via laser Doppler flowmetry; skin was heated to $44^{\circ}C$ to achieve maximal cutaneous vasodilation. Skin blood flow was measured before and after exercise in a hot room, and at 0 minutes, 10 minutes, 20 minutes, and 30 minutes of recovery under temperature conditions ($25.3{\pm}1.2^{\circ}C$, $40.3{\pm}13.7%\;RH$). Platelet clotting time was assessed before drug administration, and before and after exercise. Results: Fifteen firefighters completed the study. Aspirin increased clotting time before and after exercise compared with placebo (p = 0.003). There were no differences in absolute skin blood flow between groups (p = 0.35). Following exercise, cutaneous vascular conductance (CVC) was $85{\pm}42%$ of maximum in the aspirin and $76{\pm}37%$ in the placebo groups. The percentage of maximal CVC did not differ by treatment before or after recovery. Neither maximal core body temperature nor heart rate responses to exercise differed between trials. Conclusion: There were no differences in skin blood flow during uncompensable heat stress following exercise after aspirin or placebo therapy.

• Korean Journal of Fisheries and Aquatic Sciences
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• v.52 no.5
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• pp.452-460
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• 2019

Exposure to heavy metals through the consumption of contaminated seafood poses a health risk to humans. In Korea, seafood imports are increasing with consumption, with the largest increase in imported seafood coming from Russia. Peter the Great Bay and the Razdolnaya River are both major fisheries and protected areas under the Northwest Pacific Action Plan located near Vladivostok, Russia. This study analyzed heavy metal [cadmium (Cd), lead (Pb), total mercury (tHg), and total (tAs), and inorganic (iAs) arsenic] concentrations in shellfish and crustaceans collected from these areas. Except for iAs, the major toxic heavy metal concentrations of the samples met the national standards (Cd, 0.024-0.982 and 0.003-0.379 mg/kg; Pb, 0.021-1.533 and 0.002 mg/kg; tHg, 0.006-0.015 and 0.036-0.097 mg/kg). The tAs concentrations of three samples exceeded the Russian standard (5 mg/kg, wet weight), whereas the iAs concentrations were extremely low (ND-0.033 mg/kg). Compared with the provisional tolerable weekly intake (PTWI) of the Ministry of Food and Drug Safety and Joint FAO/WHO Expert Committee on Food Additives, the percentages of PTWI of Cd, Pb, and tHg were 0.239%, 0.001-0.049%, and 0.013-0.302%, respectively. These findings reveal that there is no potential health risk by heavy metals through the consumption of Russian seafood obtained in the surveyed areas.

• Quality Improvement in Health Care
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• v.2 no.1
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• pp.86-109
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• 1995

Clinical trials of drugs on humans is the final and most important stage in evaluating the safety and efficacy of the drugs. Good Clinical Practice(GCP) standards were announced in 1987 to protect testees' rights as well as to ensure validity of the clinical trial results, but its implementation has been delayed until now. The purpose of this study is to evaluate the preparedness of the designated institutions to abide by GCP standards during clinical trials, and thereby to determine GCP implementability at the institutions. Survey on the status of clinical trials was conducted for the designated 83 clinical trial hospitals. Response rate was 95.2%. Donabedian's quality assessment model was applied as the basic framework for the study. And the relative - weights for the evaluation items were determined by expert's evaluation. Among the designated 83 hospitals, 39 conducted clinical trials to obtain drug manufacturing approval from 1990 to 1994. Only 19 institutions are found to be able to meet the requirements of KGCP. Structure variables - manpower, organization, and facility -, which are the basic elements for GCP, are evaluated as unsatisfied in many hospitals. Institutions which established IRB accounted for 41 or 51.9%, but those who have a protocol evaluation guideline, or Adverse Drug Reaction(ADR) reporting system were only 12 and 21 institutions, respectively. Also, the institutions providing educational programs on conducting clinical trials are few - 20. The study results indicates that the level of conducting KGCP is unsatisfactory. However, more institutions are expected to be able to meet the standards soon because GCP standards does not require so much regulation on facilities, but stress importance on research methodology and human right. At present as the institutions for clinical trials are primarily training hospitals with residency programs, such efforts as education will accelerate the implementability of GCP in Korea. Institutions must build the appropriate infrastructure and government must prepare to strongly enforce KGCP before it can successfully take place.

• Korean Journal of Pharmacognosy
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• v.49 no.2
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• pp.124-131
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• 2018

Phytolaccae Radix has long been used as a traditional indigenous medicine to cure edema and rheumatism. However, there is insufficient background information on toxicological evaluation of Phytolaccae Radix extract to support the safe use. Therefore, we conducted a series of standardized, OECD and KFDA guidelines compliant in vivo study, to find a dose levels for the 13 weeks toxicity study. The extract of Phytolaccae Radix was administered orally to F344 rats at dose levels of 0, 500, 1000 and 2000 mg/kg/day for 2 weeks. Each group was composed to five male and five female rats. In the result, there were no test article-related adverse changes in clinical signs, body weight, food consumption, ophthalmology, hematology, clinical chemistry, gross finding at necropsy and organ weight examination. Therefore, we recommend that 2000 mg/kg/day is a highest treatment group in 13-week exposure study.

• Asian Pacific Journal of Cancer Prevention
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• v.13 no.9
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• pp.4669-4675
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• 2012

Objective: Nude mice with orthotopic transplantation of human ovarian epithelial cancer were used to investigate screening criteria for paraneoplastic normal ovarian tissue and the security of the freezing and thawing for ovarian tissue transplantation. Methods: Expression of CK-7, CA125, P53, survivin, MMP-2/TIMP-2 in paraneoplastic normal ovarian tissues were detected by RT-PCR as well as immunohistochemistry. The tissues of the groups with all negative indicators of RT-PCR, all negative indicators of immunohistochemistry, negative expression of CK-7, CA125 and survivin, positive expression of CK-7, CA125 and survivin, cancer tissues and normal ovarian tissues of nude mice were used for freezing and thawing transplantation, to analyze overt and occult carcinogenesis rates after transplantation. Results: When all indicators or the main indicators, CK-7, CA125 and survivin, were negative, tumorigenesis did not occur after transplantation. In addition the occult carcinogenesis rate was lower than in the group with positive expression of CK-7, CA125 and survivin (P<0.01). After subcutaneous and orthotopic transplantation of ovarian tissues, rates did not change (P>0.05). There was no statistical significance among rates after transplantation of ovarian tissues which were obtained under different severity conditions (P>0.05). Conclusion: Negative expression of CK-7, CA125 and survivin can be treated as screening criteria for security of ovarian tissues for transplantation. Immunohistochemical methods can be used as the primary detection approach. Both subcutaneous and orthotopic transplantation are safe. The initial severity does not affect the carcinogenesis rate after tissue transplantation. Freezing and thawing ovarian tissue transplantation in nude mice with human epithelial ovarian carcinoma is feasible and safe.

• The Korean Journal of Pesticide Science
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• v.20 no.1
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• pp.23-29
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• 2016

This study was carried out to survey residual characteristics of pesticide in fresh ginsengs collected from 45 markets at 15 regions in Korea using multiresidue analysis with a GC-MS/MS and an LC-MS/MS. After residue analysis was performed, the pesticides detected from ginsengs were quantitated using their analytical methods validated by recovery tests with a GC-ECD/NPD. As a results of analysis of pesticide residue, cypermethrin, fenitrothion, fludioxonil, thifluzamide, and tolclofos-methyl were detected from 16 samples among 45 samples in total, indicating detection rate was 35.6%. Tolclofos-methyl was found to be highest in detection frequency in ginseng. Fenitrothion that has not established maximum residue limit and pre-harvest interval for ginseng was detected. The amounts of all pesticides detected were less than their MRLs. Ratios of estimated daily intakes to acceptable daily intakes of the detected pesticides in ginseng were found to be from 0.03 to 16.67%.

• The Korean Journal of Applied Statistics
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• v.23 no.1
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• pp.139-150
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• 2010

In recent years, more generic drug products became available. The current regulation for assessing the bioequivalence of two drug formulations is based on the concept of average bioequivalence. This approach has been indicated to be insufficient for assessing switchability between two drug formulations and US FDA has adopted individual bioequivalence as one of the bioequivalence criterion since 2001. The US FDA recommends that individual bioequivalence be assessed based on $2\;{\times}\;4$ crossover design, while a $2\;{\times}\;3$ crossover design may be used as an alternative design to reduce the length and cost of the study. In this paper, a statistical procedure for assessment of individual bioequivalence under $3\;{\times}\;2$ crossover designs is proposed and some statistical points are discussed with $2\;{\times}\;3$ crossover design and $2\;{\times}\;3$ extra-reference design through simulation studies.

• Korean Journal of Food Science and Technology
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• v.40 no.5
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• pp.503-509
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• 2008

In this study, the daily intake of preservatives in the Korean population was estimated, using data from national health and nutrition studies regarding the concentration of preservatives in each type of food, food intake by sex, age group, and weight. The level of safety of these preservatives was evaluated via comparisons with the acceptable daily intake (ADI) data established by the Joint FAO/WHO expert committee on food additives (JECFA). The Estimated daily intake (EDI) of sorbic acid is 495.85 ${\mu}g$/kg bw, benzoic acid is 215.34 ${\mu}g$/kg bw and parahydroxybenzoate is 5.01 ${\mu}g$/kg bw per day each. Their percentages in relation to ADI are 2, 4.3, and 0.1%, respectively. The comparatively high-consuming groups were taking sorbic acid 1,012.06 ${\mu}g$/kg bw, benzoic acid 229.56 ${\mu}g$/kg bw, and parahydroxybenzoate 11.58 ${\mu}g$/kg bw per day, and their intake levels as a percentage of ADI were 4.1, 4.6, 0.1%, all within safe levels. Males were found to have taken more benzoic acid than women, whereas we detected no sighificant differences in the intakes of sorbic acid and parahydroxybenzoate between males and females. The EDI of sorbic acid, benzoic acid, and parahydroxybenzoate were lower than the ADI in all age groups studied.

• Journal of Korean Medicine Rehabilitation
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• v.32 no.3
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• pp.131-140
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• 2022

Objectives This study aimed to investigate whether the concurrent use of conventional and herbal medications affects liver and kidney function, by examining blood test data. Methods We retrospectively reviewed the electronic medical records of 590 inpatients with musculoskeletal diseases between 2013 and 2017. We investigated cases of drug-induced liver injury (DILI) according to the Roussel Uclaf Causality Assessment Method criteria and cases of drug-induced kidney injury (DIKI) based on the Kidney Disease Improving Global Outcomes definition. Results One case (0.17%) of DILI and one case (0.17%) of DIKI were identified. Significant improvements in serum laboratory data were observed after the concurrent use of both types of medications (p<0.05). The kappa coefficients ranged from 0.26 to 0.72, indicating that the values after the concurrent use of conventional and herbal medications showed a fair similarity to the baseline values of the patients. The linear regression test showed that female sex and high body mass index (BMI) were risk factors for an increase in the serum blood levels of liver function parameters. Conclusions The concurrent use of conventional and herbal medications for musculoskeletal disorders is relatively safe; however, clinicians should exercise caution when prescribing these medications to female patients and patients with a high BMI because of their potential effect on hepatic function.