• 한국산업보건학회지
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• 제9권1호
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• pp.125-155
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• 1999

The objectives of this study were (1) an investigation of the current status of the hazardous substances, (2) a comparative analysis of classification system of hazardous substances between Korea and other countries, (3) a development of the new classification system in Korea, finally a review of prerequisites for effective enforcement of the new system. The results are summarized as follows : 1) The backbone of classification system of hazardous substances in Korea is based on Japanese classification system and EC(European Committee) guideline of hazardous substance. There are many problems in managing and handling of hazardous substances due to discordant of Japanese and EC system. It is desirable to revise the classification system to be harmonized with international guideline for example, guideline of IFCS(The Inter-governmental Forum on Chemical Safety) and EC guideline. 2) There are several problems in definitions of corrosive, sensitizing and irritation in MSDS Code of Ministry of Labour. It is desirable to reform those definitions. 3) Among the hazardous substances under the current system, there are several substances such as, beta-propiolactone, methyl bromide, ethyleneimine, etc that are not used and produced in Korea. It is desirable to exclude the substances from the list of controlled substances. 4) The section 39, about 'substance that designated to attach warning label' in Korea Occupational Safety and Health Act(OSHAct) should be eliminated, because above section is unnecessary under the MSDS system. 5) The researchers recommend to establish a new list of hazardous substance which are controlled by OSHAct. It is desirable that the new list is consist of two types. The first type is 'a list of the specially controlled substances' and the other is 'the generally controlled substances'. 6) It is recommended that the specially controlled substances should include hazardous substances that are highly toxic and widely used in Korea. And the generally controlled substances should include hazardous substances that can be analysed by instrument and carry threshold. limit values(TLV's).

• 한국응용약물학회:학술대회논문집
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• 한국응용약물학회 1997년도 추계학술대회
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• pp.57-74
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• 1997

To make a proposal for the revision of KGCP, ICH Harmonized Tripartite Guideline for Good Clinical Practice, which is on the stage of worldwide implementation, was compared with current GCPs of tripartite countries of ICH, namely USA, Europe and Japan as well as Korea. On the basis of the classification in ICH GCP, comprehensive comparisons among the corresponding articles of 4 regions or countries were made in the order of IRB / IEC, Investigator, Sponsor and Clinical Trial Protocol. Based on the comparisons of the contents in ICH-GCP with those in current GCPs, major suggestions for the revision of current KGCP can be made as follows. Firstly, the function of IRB / IEC needs to be strengthened for the initiation and continuation of clinical trial. Current 2-step approval system of IRB / IEC and Health Authorities requires to be converted into the system similar to that of developed countries. Secondly, sponsor's obligation needs to be tightened to control and assure the quality of clinical trial. Inspection of regulatory authorities should be made to perform during and / or after clinical trial, when it is necessary. In other words, sponsor should be made to establish written Standard Operating Procedures (SOPs) for all aspects of clinical trial including monitoring to ensure that trials are conducted and data are generated, documented, and reported in compliance with the protocol, GCP, and the applicable regulatory requirement (s). Besides, the provision of ‘Quality Control and Quality Assurance’ should be added to the protocol to establish the credibility of the result of the clinical trial.

• 한국인터넷방송통신학회논문지
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• 제15권6호
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• pp.209-215
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• 2015

반도체 관련 산업의 발전에 따라 반도체 제조공정에서 염산, 황산, 과산화수소, 불산, 피라니아 등과 같은 다양한 형태의 유독 가스와 화합물들이 사용되고 있고 누출 사고 역시 빈번하게 발생되고 있는 것이 사실이다. 유독 가스 누출사고 발생시 대량의 인명 피해가 발생되고 있는 것 역시 사실이다. 본 연구에서는 구미 불산 누출 사고와 같은 화학물질 누출 사고의 위험으로부터 인명을 보호하고 피해를 최소화 하기 위한 기본 해결책으로 대학에서의 MSDS 교육의 필요성에 대해 고찰하였다. 또한 GHS와 REACH 제도와 MSDS 이용의 적정성의 이해를 통해 유해 화학 물질의 노출로부터 안전을 지키는 문제에 대해 고찰하였다.

• Environmental Analysis Health and Toxicology
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• 제21권2호
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• pp.173-184
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• 2006

From the harmfulness expectation test conducted through a toxicity anticipation program, methylcyclohexane turned out to be harmful and simulative, but no carcinogenicity was anticipated. In a four-hour acute inhalation toxicity test, the result showed that lethal concentration ($LC_{50}$) was 3,750 ppm (15,054 mg/L), which was identified as a harmful substance on the basis of the harmful substance classification standard $2 of the Industrial safety and health law. methylcyclohexane fell under the category $4(2,500 substance from the GHS standard acute toxicity harmfulness classification. Also, from subchronic inhalation toxicity test that included 6 hours a day, five days a week, and for 13 weeks, we could observe weight, activity, long term weight, blood and blood biochemical influence from the exposure of test substance. No-observed effect level (NOEL) was determined below $100{\sim}400ppm$ inboth male and female. This material falls under the Category 2 ($50{\sim}250ppm/6hours/90days$) in the GHS (Globally Harmonized System) standard trace long-term whole body toxicity repeated exposure, and can be classified as a harmful substance in accordance with the Industrial Safety and Health Law harmful substance standard $NOEL{\leq}0.5mg/L/6hr/90day$ (rat).

• 한국산업보건학회지
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• 제32권3호
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• pp.209-220
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• 2022

Objectives: This study was performed to suggest how to re-establish criterion for toxic substances under the Chemical Control Act (CCA) in South Korea by comparing the GHS (Globally Harmonized System of Classification and Labeling of Chemicals) score and toxic properties. Methods: Toxic substances were classified into seven groups (Acute toxicity (1A), Chronic toxicity (2C), Environmental hazards (3E), Acute toxicity & chronic toxicity (4AC), Chronic toxicity & environmental hazards (5CE), Acute toxicity & environmental hazards (6AE), and Acute toxicity & chronic toxicity & environmental hazards (7ACE)) according to their toxic properties. The GHS score was calculated to sum up five toxicity indicators (health acute toxicity, health repeated toxicity, carcinogenicity, health other chronic toxicity and environmental hazards). Results: The GHS score of 7ACE was higher by 7 times that of 1A. 1A is the only group which has lower than the total GHS score. The highest score was 47, for sodium chromate (CAS no. 7775-11-3), which belongs to group 7ACE. This is classified as acute toxicity, carcinogenicity, germ cell mutagenicity, reproductive toxicity, and acute and chronic environmental hazard. On the other hand, the lowest score was 2.75, which was assigned to 177 chemicals belonging to group 1A. When the health acute toxicity indicator was omitted from the toxic criterion, toxic substances could be divided into the sub-groups 'human chronic hazards group' (HCG) and 'environmental hazards group' (EG) according to their GHS score and properties. Conclusions: The proposed criterion for toxic substances is to establish sub-groups defined as HCG and EG for separate control and that the 1A group be moved to substances requiring preparation for accidents under the CCA.

• 통상정보연구
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• 제17권3호
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• pp.203-222
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• 2015

본 연구에서는 미국의 판례와 법제를 살펴봄으로서 기존의 FTA관련한 법제연구가 주로 협정문해석을 위주로 하는 점을 보완하였다. 또한 향후에 우리 기업이 분쟁의 발생에 대비한 법적대응방안을 구체적으로 세우는데 연구의 주된 목적이 있다. 미국의 FTA특혜관세를 관장하는 법은 주로 미국관세법(Tariff Act of 1930)이라 할 수 있고, 이를 보완하기 위하여 각국과 체결한 자유무역협정과 연계하여 관세행정을 시행하고 있다. 연방관세법에서 주로 쟁점이 되는 사항은 상품의 분류와 관련하여 통합관세율표(Harmonized Tariff Schedule of the United States)의 해석문제라고 할 수 있다. 한미FTA협정문과 미국관세법에 의해 분쟁을 판단함에 있어 미국연방법원은 연방세관이 내리는 결정에 대하여 비교적 우호적인 태도를 취하고 있음을 알 수 있다. 이는 미연방세관당국이 통관과정에서의 많은 규제경험으로 법적인 하자를 크게 노정하지 않고 관세행정을 다루고 있음을 의미한다. 따라서 한국의 수출업자는 미국 진출시에 발생할 수 있는 관세법상의 문제점을 미리 점검하고 세관당국의 규제선례를 적극적으로 수집하여 미국세관당국의 조치를 사전에 예상하고 이에 대한 대비책을 미리 세우는 것이 중요할 것이다.

• 한국가스학회지
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• 제17권5호
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• pp.42-50
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• 2013

급속한 산업발전과 더불어 전 세계적으로 약 10만 여종의 산업용 물질이 사용되고 있으며, 매년 2,000여종의 신규물질이 개발되고 있다. 이러한 물질들은 인류문화 발전에 크게 기여하고 있지만 일부 물질들은 유해, 위험성 등의 잠재적인 위험성을 가지고 있다. 우리나라는 세계 7대 화학제품 생산국가로, 활발한 수출 입을 통해 국가부흥에 기여하고 있다. 최근 REACH 및 GHS와 같은 화학물질 안전관리에 대한 국제적 관심이 증대되어 그에 따른 효율적인 화학물질 관리체계 구축에 대한 필요성이 커지고 있다. 본 연구에서는 화학물질에 대한 국내, UN GHS 물리화학적 위험성 분류기준, 표지 및 위험성 평가 시험방법, 위험물안전관리법 등에서 정한 분류정보의 차이점을 비교하였으며, 또한 국제 환경변화에 대응하기 위하여 선택가능방식(building block approach)으로 GHS제도 도입방안을 제시하였다. 또한 소비자에게 화학물질의 통일화된 위험성 정보를 제공하여 산업체가 화학물질을 해외로 수출 입 하는데 무역장벽을 해소하고자 하였다.

• 한국산업보건학회지
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• 제20권4호
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• pp.282-294
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• 2010

The purpose of SAICM (Strategic Approach to International Chemicals Management) is to minimize the health and environmental hazards from the production and the consumption of chemicals by improving the chemicals management capability of developing countries and implementing a system of the risk assessment and the management based on the precautionary principle until 2020. To achieve this purpose, the UN has prescribed the principles, objectives and establishment of an action plan for the chemicals management strategy which must be carried out at international, local, and national levels, and requested the implementation of the Global Plan of Action (GPA) comprising of 273 recommendations in 36 work areas. SAICM is currently based on voluntary participation, but is expected to become the basic framework of international order in relation to chemicals management in the future. This study aims to analyze the practice in the occupational safety and health area relating to implement 273 recommendations of the GPA, and propose complementary measures for the system in order to provide political advices for establishing future plans to manage industrial chemicals. Twenty three areas of total 36 work areas and 161 items of 273 recommendations have relevance to occupational safety and health areas. We have found that, as a national implementation level, 157 of 161 industrial safety and health items are being implemented at a satisfactory level in regard to the implementation of the GPA, while 4 items, including the ratification of the ILO Conventions 170, 174, 184, and support for GHS (Globally Harmonized System of Classification and Labeling of chemicals) implementation of developing countries, require additional complementary measures for the system and operation.

• Toxicological Research
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• 제25권3호
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• pp.132-139
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• 2009

The toxicity test of ammonium persulfate was conducted to ensure of its potential toxic effects according to the single-dose acute oral toxicity study (OECD Guideline 423) and 90-day repeated dose sub-chronic oral toxicity study guideline (OECD Guideline 408) for establishing national chemical management system, and matching in the Globally Harmonized Classification System (GHS) category. In acute oral toxicity study, pasty stool, perineal contamination and temporary body weight decrease were observed after dosing 1st and 2nd challenge (300 mg/kg body weight). All test animals were dead within 6 hours after dosing at 3rd challenge (2000 mg/kg body weight). Therefore, the GHS class of test substance is considered class 4. In sub-chronic toxicity study, body weight changes, food consumptions, hematological, biochemical and pathological examination did not show any noticeable and significant differences between the administered (5, 20, 80 mg/kg body weight) and control (vehicle only) group animals. Based on these results, the no observed adverse effect level (NOAEL) is considered above 80 mg/kg body weight.

• Environmental Analysis Health and Toxicology
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• 제29권
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• pp.4.1-4.10
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• 2014

Objectives Effects of nanoparticles including zinc oxide nanoparticles, titanium oxide nanoparticles, and their mixtures on skin corrosion and irritation were investigated by using in vitro 3D human skin models ($KeraSkin^{TM}$) and the results were compared to those of an in vivo animal test. Methods Skin models were incubated with nanoparticles for a definite time period and cell viability was measured by the 3-(4, 5-dimethylthiazol-2-yl)-2.5-diphenyltetrazolium bromide method. Skin corrosion and irritation were identified by the decreased viability based on the pre-determined threshold. Results Cell viability after exposure to nanomaterial was not decreased to the pre-determined threshold level, which was 15% after 60 minutes exposure in corrosion test and 50% after 45 minutes exposure in the irritation test. IL-$1{\alpha}$ release and histopathological findings support the results of cell viability test. In vivo test using rabbits also showed non-corrosive and non-irritant results. Conclusions The findings provide the evidence that zinc oxide nanoparticles, titanium oxide nanoparticles and their mixture are 'non corrosive' and 'non-irritant' to the human skin by a globally harmonized classification system. In vivo test using animals can be replaced by an alternative in vitro test.