• Title/Summary/Keyword: act on the registration and evaluation

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Applicability of QSAR Models for Acute Aquatic Toxicity under the Act on Registration, Evaluation, etc. of Chemicals in the Republic of Korea (화평법에 따른 급성 수생독성 예측을 위한 QSAR 모델의 활용 가능성 연구)

  • Kang, Dongjin;Jang, Seok-Won;Lee, Si-Won;Lee, Jae-Hyun;Lee, Sang Hee;Kim, Pilje;Chung, Hyen-Mi;Seong, Chang-Ho
    • Journal of Environmental Health Sciences
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    • v.48 no.3
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    • pp.159-166
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    • 2022
  • Background: A quantitative structure-activity relationship (QSAR) model was adopted in the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH, EU) regulations as well as the Act on Registration, Evaluation, etc. of Chemicals (AREC, Republic of Korea). It has been previously used in the registration of chemicals. Objectives: In this study, we investigated the correlation between the predicted data provided by three prediction programs using a QSAR model and actual experimental results (acute fish, daphnia magna toxicity). Through this approach, we aimed to effectively conjecture on the performance and determine the most applicable programs when designating toxic substances through the AREC. Methods: Chemicals that had been registered and evaluated in the Toxic Chemicals Control Act (TCCA, Republic of Korea) were selected for this study. Two prediction programs developed and operated by the U.S. EPA - the Ecological Structure-Activity Relationship (ECOSAR) and Toxicity Estimation Software Tool (T.E.S.T.) models - were utilized along with the TOPKAT (Toxicity Prediction by Komputer Assisted Technology) commercial program. The applicability of these three programs was evaluated according to three parameters: accuracy, sensitivity, and specificity. Results: The prediction analysis on fish and daphnia magna in the three programs showed that the TOPKAT program had better sensitivity than the others. Conclusions: Although the predictive performance of the TOPKAT program when using a single predictive program was found to perform well in toxic substance designation, using a single program involves many restrictions. It is necessary to validate the reliability of predictions by utilizing multiple methods when applying the prediction program to the regulation of chemicals.

Existing test data for the Act on Registration & Evaluation, etc. of Chemical Substances

  • Choi, Bong-In;Ryu, Byung-Taek;Na, Suk-Hyun;Chung, Seon-Yong
    • Environmental Analysis Health and Toxicology
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    • v.30
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    • pp.17.1-17.6
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    • 2015
  • Objectives In this study, the possibility of using existing test data provided in Korea and elsewhere for the registration of chemical substances was examined. Data on 510 chemical substances that are among the first subject to registration under the "Act on the Registration and Evaluation, etc. of Chemical Substances (K-REACH)" were analyzed. Methods The possibility of using existing data from 16 reference databases was examined for 510 chemical substances notified in July 2015 as being subject to registration. Results Test data with the reliability required for the registration of chemical substances under the K-REACH constituted 48.4% of the required physicochemical characteristics, 6.5% of the required health hazards, and 9.4% of the required environmental hazards. Conclusions Some existing test data were not within the scope of this research, including data used for registration in the European Union (EU). Thus, considering that 350 of these 510 species are registered in EU Registration, Evaluation, Authorisation & Restriction of Chemicals, more test data may exist that can be utilized in addition to the data identified in this study. Furthermore, the K-REACH states that non-testing data (test results predicted through Read Across, Quantitative Structure-Activity Relationships) and the weight of evidence (test results predicted based on test data with low reliability) can also be utilized for registration data. Therefore, if methods for using such data were actively reviewed, it would be possible to reduce the cost of securing test data required for the registration of chemical substances.

Analysis of the utilization of existing test data for phase-in substance registration under the Act on the Registration and Evaluation, etc. of Chemical Substances

  • Choi, Bong-In;Kwak, Yeong-Don;Jung, Yu-Mi;Ryu, Byung-Taek;Kim, Chang Gyun
    • Environmental Analysis Health and Toxicology
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    • v.30 no.sup
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    • pp.4.1-4.7
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    • 2015
  • Objectives Approximately 2000 phase-in substances are subject to registration according to the Act on the Registration and Evaluation, etc. of Chemical Substances (K-REACH), and the expected testing cost is 2.06 trillion Korean won assuming all the test data required for registration are acquired. The extent to which these enormous test costs can be reduced depends on the availability of existing data that can be used to meet the requirements of the K-REACH we examined the current availability of test data that can be used for chemical substance registration. Methods We analyzed the possibility of utilizing the existing test data obtained from 16 reference databases for 369 of 518 kinds of phase-in substances subject to registration that were reported in last October 2014. Results The physical and chemical properties were available for 57.1% of substances, whereas data regarding human hazards and environmental hazards were available at considerably lower rates, 8.5% and 11.8%, respectively. Conclusions Physical and chemical properties were available for a fairly high proportion, whereas human hazards and environmental hazards were reported for considerably fewer substances.

Act on the Registration and Evaluation of Chemicals (K-REACH) and replacement, reduction or refinement best practices

  • Ha, Soojin;Seidle, Troy;Lim, Kyung-Min
    • 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.

A Study on the Management of benzo[a]pyrene according to the Level of Acute Toxicity (벤조피렌의 급성독성 수준에 따른 관리적 방안 연구)

  • Kim, Mina;Lee, Seungkil;Lee, Yongsik;Cho, Samrae;Kim, Dukhyun
    • Journal of Environmental Health Sciences
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    • v.44 no.2
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    • pp.153-159
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    • 2018
  • Objectives: This study was carried out to determine $LD_{50}$ of benzo[a]pyrene to decide the possibility to designate them as toxic substance on the Act on the Registration and Evaluation, etc. of Chemical Substances, and to suggest that they should be managed in what level on the Chemical Control Act. Methods: Based on the result of a preliminary study, 300 mg/kg was set as the middle dose. A highest dose of 2,000 mg/kg and a lowest dose of 50 mg/kg were selected based on the OECD TG 423. Benzo[a]pyrene was orally administered once to female and male SD rats at dose levels of 50, 300, 2,000 mg/kg (body weight). All animals were monitored daily for clinical signs and mortality over 14 days. Also testicular spermatid count, motility and etc. were examined as well. Results: Under the condition of this experiment, $LD_{50}$ of benzo[a]pyrene was assumed to be >2,000 mg/kg. In the lesion according to autopsy, there were no specific symptoms in the control and experimental groups. At 2,000 mg/kg, a decrease in the sperm motility was observed. Benzo[a]pyrene should be designated to be toxic substance as the material assumed to be reproduction-toxicity on the Act on the Registration and Evaluation, etc. of Chemicals. Therefore we should abide by legal procedures determined by Chemicals Control Act in treating it. Conclusion: Considering the significant result that sperm motility in the experimental group was inferior to that in the reference group, we suggest that benzo[a]pyrene be designated as a toxic substance.

What must be done to prevent another humidifier disinfectant disaster?

  • Lee, Jong-Hyeon
    • Environmental Analysis Health and Toxicology
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    • v.31
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    • pp.24.1-24.7
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    • 2016
  • The humidifier disinfectant disaster (HDD) was not a simple poisoning accident by biocides, but a singular disaster in history created by chemicals in household products. This disaster was a result of the failure of a system for the management of chemical and product safety. Since the management authority for chemical usage safety is different from those for chemical safety in products, many blind areas for chemical safety management in products still remain. The 'Act on the Registration and Evaluation, etc. of Chemical Substances (ARECS)' or the new 'Biocidal Product Act' must not only address the blind areas in the management system for chemical and product safety, but also prevent a second HDD. To prevent another HDD, an integrated registration, evaluation, and management system for chemicals and consumer products must be incorporated into the 'ARECS' as an essential part for chemical safety in consumer products.

Effectiveness Analysis of Preliminary Evaluation of Public Library Establishment Feasibility Based on the Revised Library Act (도서관법 개정에 따른 공공도서관 설립 타당성 사전평가의 실효성 분석)

  • Kim, Hyo-Yoon
    • Journal of Korean Library and Information Science Society
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    • v.53 no.3
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    • pp.119-135
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    • 2022
  • The purpose of this study is to determine whether the pre-evaluation of the feasibility of establishing a public library, which is mandatory according to the revision of the Library Act, can improve the quality of the library. Therefore, the effectiveness of the preliminary evaluation was analyzed through the case analysis of the preliminary evaluation of the public library construction support project, which was implemented for the same purpose before the revision of the Library Act. In the case of libraries built after preliminary evaluation, most of the minimum standards for legal librarians required by the Enforcement Decree of the Library Act were secured, which helped secure basic library personnel. However, there were few libraries that secured and operated as much manpower as originally planned, and in some cases, the application applied to operate the library directly, but it was changed to consignment operation at the time of opening, so the pre-review details were not faithfully reflected. This study proposed re-establishing realistic librarian placement standards according to the revision of the law and introducing a post-evaluation using the library registration system so that it would not be a formal pre-process through case analysis.

Basic Features and Facts of Herbicide Evaluation for Efficacy and Phytotoxicity in Korea (제초제의 효능과 약해 평가상의 당면과제)

  • Yong-Woong Kwon
    • KOREAN JOURNAL OF CROP SCIENCE
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    • v.23 no.3
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    • pp.19-30
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    • 1978
  • Use of herbicides in Korean agriculture has increased rapidly in recent years accompanying with ever-increasing pressure of farm labor shortage. Herbicides occupied already the second place in the rank of pesticides consumption in 1977. The agricultural experiment stations have carried out over 50 trials of chemical weed control each year since 1968. These research works and registration trials contributed much to the present wide use of herbicides. The pesticide management act amended in 1977 requires reevaluation of pesticides for their efficacy every 5 year-term. However, the development of sound weed control program and recommendations has been hempered very much by the lack of qualified workers of weed control research in agricultural experiment stations and in the institute for pesticide registration trial. Critical review of the past research works on herbicide evaluation and the present status indicates strong need for 1) the characterization of the nature of local and national weed problem, 2) the improvement of ability of the staffs in charge of weed control research through appropriate training on the basics and experimental techniques, and 3) organization and activities of weed control research committee. Furthermore, the present article attempts to clarify commonly misled points in the establishment of herbicide evaluation plan, in the design and execution of field trials, and in the assessment of trial results of the past works from the viewpoint of the basic principles with some case studies for resolution of specific enigmas.

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