• Korean Journal of Clinical Pharmacy
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• v.31 no.1
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• pp.53-60
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• 2021

Objective: To gather the opinions of hands-on workers for successful introduction of the Development Safety Update Report (DSUR) according to a five-year comprehensive plan for clinical trial development [Ministry of Food and Drug Safety, 2019]. Methods: We conducted a survey on considerations that industry stakeholders may have related to the enforcement of the DSUR. A questionnaire was distributed among pharmacovigilance specialists from 13 pharmaceutical companies in South Korea on June 4, 2020. The questionnaire comprised two sections: 1) current status of the Drug Safety Data Management System and 2) considerations on the implementation and management of the DSUR. Results: All respondents have agreed the introduction of DSUR is inevitable for regulatory harmonization and safety of trial subject. However, most respondents (85%) felt concern about additional workload with DSUR implementation. They answered that format and operation system of DSUR should be harmonized with those of international standards and authorities need to minimize double burden due to related report. Conclusion: All respondents asserted that domestic DSUR should be harmonized with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2F guidelines. Respondents from global companies also suggested regulatory authorities allow DSUR written in English to replace Korean version considering their deadline for submission. Moreover, every respondent agreed regulatory authorities need delicate effort when implementing mandatory submission of DSUR to ensure that even small pharmaceutical companies with no experience in DSUR can comply with the system.

• Journal of Intelligence and Information Systems
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• v.29 no.1
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• pp.203-214
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• 2023

The Korea Customs Service is efficiently handling business with an electronic customs system that can effectively handle one-stop business. This is the case and a more effective method is needed. Import and export require HS Code (Harmonized System Code) for classification and tax rate application for all goods, and item classification that classifies the HS Code is a highly difficult task that requires specialized knowledge and experience and is an important part of customs clearance procedures. Therefore, this study uses various types of data information such as product name, product description, and product image in the item classification request form to learn and develop a deep learning model to reflect information well based on Multimodal representation learning. It is expected to reduce the burden of customs duties by classifying and recommending HS Codes and help with customs procedures by promptly classifying items.

• The monthly packaging world
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• s.245
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• pp.113-121
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• 2013

GHS는 화학물질의 분류 표시에 대한 세계조화시스템(Globally Harmonized System of Classification and Labelling of Chemicals)으로 동일한 화학물질에 대해 국제적으로 동일한 유해 위험성 분류 표시를 하기 위한 새로운 규정이다. 화학물질의 분류 표시는 화학물질이 갖는 여러 가지 유해성, 위험성을 적절히 판별하고, 그 정도에 따라 분류한 다음, 가장 이해하기 쉬운 형태로 표시하는 것이 그 목적이며 올바른 정보제공을 통한 안전관리를 강화하고 국제적인 조화를 통하여 화학물질의 적정 평가 및 국제적 교역을 증대하고자 하는데 있다. 본 고에서는 유독물 등의 분류기준 및 표시방법에 관한 규정과 유독물의 표시규격에 대해 살펴보도록 한다.

• The Korean Journal of Pesticide Science
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• v.12 no.2
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• pp.141-147
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• 2008

Globally Harmonized System (GHS) for classification and labelling will provide an internationally agreed hazard classification system of chemical products and for communication of those hazards. This study aimed for establishment of the oral acute toxic class (ATC) method and application of GHS on pesticides. The ATC method was developed for determining $LD_{50}$ estimates of chemical substances with significantly fewer animals than needed when applying conventional $LD_{50}$ tests. We carried out $LD_{50}$ test and ATC test on 13 pesticides, Although methidathion EC and parathion-ethyl EC showed significantly different in $LD_{50}$ values between $LD_{50}$ test and ATC method, there are no difference in toxicity class by GHS. Both tests on the other pesticides showed almost equal results and toxicity class by GHS. Therefore, this study indicated high possibility of application of ATC method and GHS on pesticides.

• Journal of Korean Society of Occupational and Environmental Hygiene
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• v.24 no.4
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• pp.425-435
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• 2014

Objectives: This study was performed in order to establish reliable and relative selection criteria for hazardous substances requiring management(HSRM) in the Occupational Safety and Health Act in Korea. Methods: To determine the relative criteria and weight of evidence for HSRM, we analyzed the difference between the selection method of priority substances in studies by KOSHA(Korea Occupational Safety and Health Agency) and the European Union Risk Ranking Method(EURAM). In addition, 597 hazardous substances with exposure limit valueswereanalyzed and the posted health hazards classification by MOEL(Ministry of Employee and Labor), MOE(Ministry of Environment), and EU CLP(Classification, Labelling and Packaging regulation) were compared based on GHS(Globally Harmonized System of classification and labelling of chemicals) criteria. The existing HSRM(167 substances) were evaluated for suitability by the proposed criteria in this study. Results: As a result of this study, the criteria and procedures for selecting HSRM in the Occupational Safety and Health Act were arranged utilizing GHS health hazard classification results, occupational disease cases and domestic use situations. Conclusions: The applicability of the proposed criteria was proved via the evaluation of existing HSRM(167 substances). Most HSRM (161 substances) were found to correspond to a significant health effect or substantial health effect. The question of whether to include the six substances that have been found to have general health effects as HSRM would be require further research.

• Archives of design research
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• v.16 no.4
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• pp.471-480
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• 2003

Well designed idealistic zoo requires basically a condition that the zoo is much ecologically considered for the exhibited animals, and secondly where they offer leisure for the visitors' convenience and pleasure. But it is not easy to find a zoo where they have actualized these both-sided purposes. We cannot but discuss the problem of design caused by a lack of plan-ability that is necessary when the zoo is designed. It is because every elements are not wholly unified and those diversified contents aren't mutually harmonized. Therefore, a zoo has to meet the requirement of the pleasure, study, inspection and leisure deserves a special emphasis. The zoo requires a synthesized speculation of design which the elements-Identity Program, Furniture System, animal's ecological environment, animal's showroom, cage and facilities etc., - are mutually harmonized. This study is a combined-design research on the Daegu Dal-sung Park in this concept. 1 have newly analyzed the Dal-sung Park's utilizing form in order to harmonize both visual and ecological environments.

• Safety and Health at Work
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• v.3 no.3
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• pp.224-234
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• 2012

Objectives: This study was conducted in order to obtain information concerning the health hazards that may result from a 13 week inhalation exposure of n-pentane in Sprague-Dawley rats. Methods: This study was conducted in accordance with the Organization for Economic Co-operation and Development (OECD) guidelines for the testing of chemicals No. 413 'Subchronic inhalation toxicity: 90-day study (as revised in 2009)'. The rats were divided into 4 groups (10 male and 10 female rats in each group), and were exposed to 0, 340, 1,530, and 6,885 ppm n-pentane in each exposure chamber for 6 hour/day, 5 days/week, for 13 weeks. All of the rats were sacrificed at the end of the treatment period. During the test period, clinical signs, mortality, body weights, food consumption, ophthalmoscopy, locomotion activity, urinalysis, hematology, serum biochemistry, gross findings, organ weights, and histopathology were assessed. Results: During the period of testing, there were no treatment related effects on the clinical findings, body weight, food consumption, ophthalmoscopy, urinalysis, hematology, serum biochemistry, gross findings, relative organ weight, and histopathological findings. Conclusion: The no-observable-adverse-effect level (NOAEL) of n-pentane is evaluated as being more than 6,885 ppm (20.3 mg/L) in both male and female rats. n-pentane was not a classified specific target organ toxicity in the globally harmonized classification system (GHS).

• Journal of Korean Society of Occupational and Environmental Hygiene
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• v.24 no.1
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• pp.91-102
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• 2014

Objectives: This study was performed in order to devise a procedure for supplementing the Special Management Materials in the Occupational Safety and Health Act and recommend candidate materials. The results are expected to be used as fundamental data for classification and criteria necessary to manage Special Management Materials in workplaces. Also, they are expected to be used as a basis for selecting target materials to nominate as additional Special Management Material. Methods: We investigated the selection standards for candidates and review ranges of data sources to nominate Special Management Materials. The substances classified as GHS(Globally Harmonized System of classification and labeling of chemicals) category 1A(known to have carcinogenic potential and reproductive toxicity for humans) or 1B(presumed to have carcinogenic potential and reproductive toxicity for humans) carcinogens and reproductive toxicants among the Controlled Hazardous Substances of the Regulation on Occupational Safety and Health Standards and substances with OELs(Occupational Exposure Limits) were inspected as the candidates for Special Management Materials. Conclusions: A seven-step procedure for selecting candidates to designate as Special Management Materials was suggested, including the setting of target chemicals for evaluation, classification of CMR(Carcinogens, Mutagens or Reproductive toxicants) by GHS classification and criteria, suggestion and selection of the candidates, and more. This study recommends 58 chemicals as qualified candidates to supplement the Special Management Materials.

• 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.

• Safety and Health at Work
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• v.11 no.2
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• pp.152-158
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• 2020

Background: The Globally Harmonized System of Classification and Labeling of Chemicals (GHS) was developed to enhance chemical classification and hazard communication systems worldwide. However, some of the elements such as building blocks and data sources have the potential to cause "disharmony" to the GHS, particularly in its classification results. It is known that some countries have developed their own lists of classified chemicals in accordance with the GHS to "standardize" the classification results within their respective countries. However, the lists of classified chemicals may not be consistent among these countries. Method: In this study, the lists of classified chemicals developed by the European Union, Japan, Malaysia, and New Zealand were selected for comparison of classification results for carcinogenicity, germ cell mutagenicity, and reproductive toxicity. Results: The findings show that only 54%, 66%, and 37% of the classification results for each Carcinogen, Mutagen and Reproductive toxicants hazard classes, respectively are the same among the selected countries. This indicates a "moderate" level of consistency among the classified chemicals lists. Conclusion: By using classification results for the carcinogenicity, germ cell mutagenicity, and reproductive toxicity hazard classes, this study demonstrates the "disharmony" in the classification results among the selected countries. We believe that the findings of this study deserve the attention of the relevant international bodies.