• Journal of Environmental Health Sciences
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• v.46 no.4
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• pp.423-432
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• 2020

Objectives: In this study, we analyzed the current state of delivery containers and packages and established handling guidelines to safely transport delivery containers and packages for use in research, testing, and examination reagents. Methods: Handling guidelines were revised in such categories as maintenance of the handling facilities, storage, loading and unloading, containers and packages, transportation, etc. In addition, we analyzed the current state of domestic sales for hazardous chemicals used for research, testing, and examination reagents, and investigated the handling guidelines related to delivery transportation in the USA, EU, and Japan by chemical property. Results: There are 6,160 companies selling hazardous chemicals. Among them, the 476 companies selling reagents for use in research, testing, and examination were investigated. Total amounts handled reached 425,000 tons, contributing to 0.2% of the total. For delivery transportation, internal containers and packaging was specified for chemical properties as follows: within 1 L for flammable gas, within 5 L for flammable liquid, and within 18 L for others. In addition, the maximum size of the outer package was set within 130 cm for total length, width, and height, and no dimension of the packaging could exceed 60 cm. Sixty-four hazardous chemicals with explosiveness or acute inhalation toxicity were prohibited for delivery transportation. Conclusion: Specified handling guidelines for inner and outer containers as well as packaging were regulated for delivery transportation of hazardous chemicals used for reagents. In addition, 64 hazardous chemicals were prohibited for delivery transportation. These are designed to prevent transportation accidents involving hazardous chemicals for reagents and thus protect the safety and health of transporters who handle hazardous chemicals.

• Environmental Analysis Health and Toxicology
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• v.24 no.3
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• pp.261-270
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• 2009

To make measurable regulatory decisions of chemicals, it is necessary to consider their effect on the human health and ecosystem. In principle, this is based on relevant toxicity studies conducted by accepted guidelines. However, current regulatory programs in various countries confront challenges related to risk assessment of large numbers of chemicals within the restricted resources and time. Therefore there is a need for more efficient approach to limit the number of tests to be conducted. This promotes the development of powerful nontesting methods (e.g. (Q)SARs) and permits to use the predicted data for regulatory purpose. In this article, current status of non-testing methods in various chemical regulatory programs was reviewed in terms of their application and research activity on them. Finally, their usefulness associated with development of domestic regulatory program was suggested.

• Journal of Korean Society of Occupational and Environmental Hygiene
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• v.24 no.4
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• pp.578-586
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• 2014

Objectives: There is a requirement to establish the standard operating procedures(SOPs) for chronic inhalation/carcinogenicity testing, so we would like to set them appropriately. Methods and Results: We established SOPs according to guidelines from international organizations such as OECD, the US EPA, and relevant institutions in advanced countries. We also benchmarked other contract research organizations(CROs) in Korea. Conclusions: We created appropriate SOPs for chronic inhalation/carcinogenicity testing.

• Environmental Analysis Health and Toxicology
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• v.31
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• pp.26.1-26.9
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• 2016

Objectives Korea's Act on the Registration and Evaluation of Chemicals (K-REACH) was enacted for the protection of human health and the environment in 2015. Considering that about 2000 new substances are introduced annually across the globe, the extent of animal testing requirement could be overwhelming unless regulators and companies work proactively to institute and enforce global best practices to replace, reduce or refine animal use. In this review, the way to reduce the animal use for K-REACH is discussed. Methods Background of the enforcement of the K-REACH and its details was reviewed along with the papers and regulatory documents regarding the limitation of animal experiments and its alternatives in order to discuss the regulatory adoption of alternative tests. Results Depending on the tonnage of the chemical used, the data required ranges from acute and other short-term studies for a single exposure route to testing via multiple exposure routes and costly, longer-term studies such as a full two-generation reproducibility toxicity. The European Registration, Evaluation, Authorization and Restriction of Chemicals regulation provides for mandatory sharing of vertebrate test data to avoid unnecessary duplication of animal use and test costs, and obligation to revise data requirements and test guidelines "as soon as possible" after relevant, validated replacement, reduction or refinement (3R) methods become available. Furthermore, the Organization for Economic Cooperation and Development actively accepts alternative animal tests and 3R to chemical toxicity tests. Conclusions Alternative tests which are more ethical and efficient than animal experiments should be widely used to assess the toxicity of chemicals for K-REACH registration. The relevant regulatory agencies will have to make efforts to actively adopt and uptake new alternative tests and 3R to K-REACH.

• Korean Journal of Environmental Agriculture
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• v.26 no.3
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• pp.254-258
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• 2007

Several physicochemical properties including water solubility, vapor pressure, and hydrolysis of bistrifluron benzoylphenylurea insecticide developed in Korea, were measured based on OECD guidelines for testing of chemicals and Toxic Substances Control Act Test guidelines. Water solubility was low showing 30 ${\mu}g/l$ at $25^{\circ}C$ and in hydrolysis study, half-life at $20^{\circ}C$ was 10.9 days (pH 9.0) and was stable in pH 7.0 solution. At $40^{\circ}C$ hydrolysis rate was 20.6 days (pH 7.0) and 1.5 days (pH 9.0). The vapor pressure of bistrifluron was not obtained from vapor pressure experiments at $25^{\circ}C$ because the bistrifluron was not detected. Therefore, the vapor pressure was determined to be ${\leq}\;2.05{\times}10^{-8}$ torr which was calculated to apply the detection limit (50 ng) of bistrifluron. And this value is suggests it would not give environmental contamination by volatilization.

• Korean Journal of Medicinal Crop Science
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• v.27 no.3
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• pp.173-185
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• 2019

Background: Galgeun-tang used in traditional Korean medicine, is a mixture of the medicinal plants Cinnamomi Ramulus, Ephedrae Herba and Puerariae Radix, and has been prescribed for the treatment of various ailments, including fever. Although the use of traditional medicinal herbs to treat diseases has recently increased, their safety and toxicity profiles incompletely elucidated. Thus, we evaluated Galgeun-tang's toxicity in male and female Sprague-Dawley rats. Methods and Results: Galgeun-tang (1,000, 2,000 and 4,000 mg/kg) was orally administered to rats for 13 weeks, and then, they were maintained for 4 weeks without administration (recovery period). Their clinical signs, and hematological and urinary properties, were monitored. The results showed that Galgeun-tang administeration slightly increased serum creatinine, urea nitrogen and, aspartate aminotransferase levels. Additionally, 2,000 and 4,000 mg/kg Galgeun-tang significantly increased urinary bilirubn and protein levels of male and female rats, which were restored during the recovery period. Conclusions: The no-observed-adverse-effect level of orally administered Galgeun-tang was 4,000 mg/kg in both female and male rats, and no target organs were identified. In addition, 400 mg/kg was found to be the no-observed-effect level for toxicity under the study conditions.

• The Korean Journal of Applied Statistics
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• v.37 no.3
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• pp.355-380
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• 2024

In this paper, we compare the performance of graph-based deep learning models using OECD test guideline (TG) data. OECD TG are a unique tool for assessing the potential effects of chemicals on health and environment. but many guidelines include animal testing. Animal testing is time-consuming and expensive, and has ethical issues, so methods to find or minimize alternatives are being studied. Deep learning is used in various fields using chemicals including toxicity prediciton, and research on graph-based models is particularly active. Our goal is to compare the performance of graph-based deep learning models on OECD TG data to find the best performance model on there. We collected the results of OECD TG from the website eChemportal.org operated by the OECD, and chemicals that were impossible or inappropriate to learn were removed through pre-processing. The toxicity prediction performance of five graph-based models was compared using the collected OECD TG data and MoleculeNet data, a benchmark dataset for predicting chemical properties.

• International Journal of Stem Cells
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• v.17 no.2
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• pp.102-112
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• 2024

An organoid is a self-organized three-dimensional structure derived from stem cells that mimics the structure, cell composition, and functional characteristics of specific organs and tissues and is used for evaluating the safety and effectiveness of drugs and the toxicity of industrial chemicals. Organoid technology is a new methodology that could replace testing on animals testing and accelerate development of precision and regenerative medicine. However, large variations in production can occur between laboratories with low reproducibility of the production process and no internationally agreed standards for quality evaluation factors at endpoints. To overcome these barriers that hinder the regulatory acceptance and commercialization of organoids, Korea established the Organoid Standards Initiative in September 2023 with various stakeholders, including industry, academia, regulatory agencies, and standard development experts, through public and private partnerships. This developed general guidelines for organoid manufacturing and quality evaluation and for quality evaluation guidelines for organoid-specific manufacturing for the liver, intestines, and heart through extensive evidence analysis and consensus among experts. This report is based on the common standard guideline v1.0, which is a general organoid manufacturing and quality evaluation to promote the practical use of organoids. This guideline does not focus on specific organoids or specific contexts of use but provides guidance to organoid makers and users on materials, procedures, and essential quality assessment methods at end points that are essential for organoid production applicable at the current technology level.

• Environmental Analysis Health and Toxicology
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• v.31
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• pp.2.1-2.4
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• 2016

Objectives In this study, we investigated the biodegradation features of 4 perfluorooctanesulfonate (PFOS) alternatives developed at Changwon National University compared to those of PFOS. Methods Biodegradation testing was performed with microorganisms cultured in the good laboratory practice laboratory of the Korea Environment Corporation for 28 days following the Organization for Economic Cooperation and Development guidelines for the testing of chemicals (Test No. 301 C). Results While $C_8F_{17}SO_3Na$, PFOS sodium salt was not degraded after 28 days, the 4 alternatives were biodegraded at the rates of 20.9% for $C_{15}F_9H_{21}S_2O_8Na_2$, 8.4% for $C_{17}F_9H_{25}S_2O_8Na_2$, 22.6% for $C_{23}F_{18}H_{28}S_2O_8Na_2$, and 23.6% for $C_{25}F_{17}H_{32}O_{13}S_3Na_3$. Conclusions $C_{25}F_{17}H_{32}S_3O_{13}Na_3$, $C_{23}F_{18}H_{28}S_2O_8Na_2$, and $C_{15}F_9H_{21}S_2O_8Na_2$ were superior to PFOS in terms of biodegradation rates and surface tension, and thus they were considered highly applicable as PFOS alternatives. Environmental toxicity, human toxicity, and economic feasibility of these compounds should be investigated prior to their commercialization.

• Journal of Korean Society of Occupational and Environmental Hygiene
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• v.24 no.2
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• pp.169-181
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• 2014

Objectives: The purpose of this study was to obtain information regarding classification and health hazards that may result from a 13-week inhalation exposure to 2-methylpentane by Sprague-Dawley rats. Materials: The testing method was conducted in accordance with OECD guidelines for the testing of chemicals No. 413. The rats were divided into four groups(ten male and ten female rats in each group) and exposed to 0 ppm, 290 ppm, 1,160 ppm, 4,640 ppm 2-Methylpentane in each exposure chamber for six hours per day, five days per week, for 13 weeks. Results: No death or particular clinical presentation including weight change and change of feed rate was observed. The relationships between dose, gender and response were also not significantly changed in urinalysis, hematologic examination, or biochemical examination of blood(except for total cholesterol being up, total protein being up, and chloride ion being down in males), and blood coagulation time. For the relative weight measurement of organs, in the male group the weight change of both kidney and liver were increased in proportion to dose. In histopathological examination, nephropathy in the kidney(cystic change of renal tubules, regenerative tubule, inflammatory cell infiltration and necrosis in the interstitial tissue) was increased in a dose-dependent manner in the male group(290 ppm, 1,160 ppm, 4,640 ppm). However, other organs were not affected by the test substance. Conclusions: 2-methylpentane was estimated as a chemical causing nephropathy in the male group. NOAEL(No Observable Adverse Effect Level) in the female group is more than 4,640 ppm, while inthe male group it is less than 290 ppm.