Solvents can be used in the manufacture of medicinal products provided their residual levels in the final product comply with the acceptable limits based on safety data. At worldwide level, these limits are set by the "Guideline Q3C (R6) on impurities: guideline for residual solvents" issued by the ICH. Diisopropyl ether (DIPE) is a widely used solvent but the possibility of using it in the pharmaceutical manufacture is uncertain because the ICH Q3C guideline includes it in the group of solvents for which "no adequate toxicological data on which to base a Permitted Daily Exposure (PDE) was found". We performed a risk assessment of DIPE based on available toxicological data, after carefully assessing their reliability using the Klimisch score approach. We found sufficiently reliable studies investigating subchronic, developmental, neurological toxicity and carcinogenicity in rats and genotoxicity in vitro. Recent studies also investigated a wide array of toxic effects of gasoline/DIPE mixtures as compared to gasoline alone, thus allowing identifying the effects of DIPE itself. These data allowed a comprehensive toxicological evaluation of DIPE. The main target organs of DIPE toxicity were liver and kidney. DIPE was not teratogen and had no genotoxic effects, either in vitro or in vivo. However, it appeared to increase the number of malignant tumors in rats. Therefore, DIPE could be considered as a non-genotoxic animal carcinogen and a PDE of 0.98 mg/day was calculated based on the lowest No Observed Effect Level (NOEL) value of $356mg/m^3$ (corresponding to 49 mg/kg/day) for maternal toxicity in developmental rat toxicity study. In a worst-case scenario, using an exceedingly high daily dose of 10 g/day, allowed DIPE concentration in pharmaceutical substances would be 98 ppm, which is in the range of concentration limits for ICH Q3C guideline class 2 solvents. This result might be considered for regulatory decisions.
Journal of the Korean Society for Marine Environment & Energy
/
v.6
no.4
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pp.3-12
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2003
Due to the high demand on energy resources accompanied by continuing industrialization and urbanization, the world marine transportation of crude and product oils is being gradually increased. In Korea, we are exposed to the large-scale marine oil spill accidents because a very large oil tanker of 300,000 tonnage must enter Korean Ports every day to meet the domestic demand on oils. Although we are exerting our strength to reduce the probability of marine oil pollution accidents, a unrestorable oil spill is to occur owing to human errors, severe weather conditions, or combined causes. Thus, area contingency plan equipped with appropriate management system for response and restoration for the worst case discharge scenario must be entirely prepared to protect mine environments and coastal resources. In particular, we are focusing on the Environmental Sensitivity Index Map(ESI Map) to reduce the environmental consequences of both spills and clean-up efforts by specifying protection Priorities in advance and identifying in-situ response strategies. In this paper, Korean ESI Map is introduced with brief definition of sensitivity to oiling and main features of the software developed hitherto.
There is growing interest in solar power generation due to global warming. As a result, demand for polysilicon, which is the core material for solar cells, is increasing day by day. As the market grows, large and small accidents occurred in the production process. In 2013, hydrochloric acid leaked from the polysilicon manufacturing plant in SangJu. In 2014, a fire occurred at a polysilicon manufacturing plant in Yeosu, and in 2015, STC(Silicon Tetrachloride) leaked at a polysilicon manufacturing plant in Gunsan City. Leakage of chemicals in the polysilicon manufacturing process can affect not only the workplace but also the surrounding area. Therefore, in this study, we identified the hazardous materials used in the polysilicon manufacturing process and quantitatively estimate the amount of leakage and extent of damage when the worst case scenario is applied. As a result, the damage distance by explosion was estimated to be 726 m, and the damage distance to toxicity was estimated to be 4,500 m. And, if TCS(Trichlorosilane), STC(Silicon Tetrachloride), DCS(Dichlorosilane) leaks into the air and reacts with water to generate HCl, the damage distance is predicted to 5.7 km.
The design and analysis of a quayside mooring system for safe mooring of Prelude FLNG under extreme environmental conditions were carried out. The design of the mooring system considered the yard operation conditions and maximum wind speed during a typhoon. In order to secure the mooring safety of Prelude FLNG under an extreme environment, a special steel structure was designed between the quay and Prelude FLNG to maintain the distance from the quay to a certain extent to avoid a collision with the inclined base. The mooring safety was also ensured by installing additional new parts on the quay. A mooring analysis and mooring safety review were performed with more rigorous modeling considering the nonlinearity of the mooring rope and fender. In order to secure additional safety of the mooring system under extreme environmental conditions, a safety assessment was conducted on the failures of the mooring components proposed in the marine mooring guidelines. Based on the results of the mooring analysis, it was confirmed that the Prelude FLNG can be safely moored even under the extreme conditions of typhoons, and a worst case scenario analysis verified that the mooring system design was robust enough. The proposed mooring analysis and design method will provide a basis for the safe mooring of ultra-large floating offshore structures of similar size in the future.
Studer, Ahren;Bai, Fan;Bellur, Bhargav;Perrig, Adrian
Journal of Communications and Networks
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v.11
no.6
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pp.574-588
/
2009
Although much research has been conducted in the area of authentication in wireless networks, vehicular ad-hoc networks (VANETs) pose unique challenges, such as real-time constraints, processing limitations, memory constraints, frequently changing senders, requirements for interoperability with existing standards, extensibility and flexibility for future requirements, etc. No currently proposed technique addresses all of the requirements for message and entity authentication in VANETs. After analyzing the requirements for viable VANET message authentication, we propose a modified version of TESLA, TESLA++, which provides the same computationally efficient broadcast authentication as TESLA with reduced memory requirements. To address the range of needs within VANETs we propose a new hybrid authentication mechanism, VANET authentication using signatures and TESLA++ (VAST), that combines the advantages of ECDSA signatures and TESLA++. Elliptic curve digital signature algorithm (ECDSA) signatures provide fast authentication and non-repudiation, but are computationally expensive. TESLA++ prevents memory and computation-based denial of service attacks. We analyze the security of our mechanism and simulate VAST in realistic highway conditions under varying network and vehicular traffic scenarios. Simulation results show that VAST outperforms either signatures or TESLA on its own. Even under heavy loads VAST is able to authenticate 100% of the received messages within 107ms. VANETs use certificates to achieve entity authentication (i.e., validate senders). To reduce certificate bandwidth usage, we use Hu et al.'s strategy of broadcasting certificates at fixed intervals, independent of the arrival of new entities. We propose a new certificate verification strategy that prevents denial of service attacks while requiring zero additional sender overhead. Our analysis shows that these solutions introduce a small delay, but still allow drivers in a worst case scenario over 3 seconds to respond to a dangerous situation.
Roh, Young-Man;Lee, Cheol Min;Kim, Yoon Shin;Kim, Seok Won;Kim, Chi-Nyon;Kim, Hyun-Wook;Cho, Kee Hong;Choi, Ho Chun;Kim, Jung Man
Journal of Korean Society of Occupational and Environmental Hygiene
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v.16
no.1
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pp.54-67
/
2006
This study was performed to deduct the extension possibility of the standards establishment for $NO_2$, $O_3$, Asbestos, Radon, total volatile organic compounds (TVOC) excluded in the indoor air part of Industrial Safety Acts in Korea. The air pollutants were sampled for 30 office buildings from August to September, 2005 in the metropolitan area. The airborne concentrations of $NO_2$, $O_3$, Radon and TVOC were 0.0092 ppm, 0.0035 ppm, 0.57 pCi/L and $423{\mu}g/m^3$, respectively. The management plan and reduction methods is required in the aspect of indoor air quality(IAQ) because the emission sources of those also exist in indoor as well as outdoor even though those were not exceeded the standards of the Ministry of Environment in Korea. The standard for TVOC in the new and remodeling office has to be established based on the risk assessment when hazard index exceeded "1" in the worst case scenario. In the state of art, the management of each volatile organic compounds has a difficulty due to not enough data for toxicological reference. Therefore, it is suggested that first of all, the standard for TVOC be established and then expanded to each materials for decision-making of improvement of IAQ in office.
As a way to propose a method for the establishment of practical damage-minimizing plan for chemical plants, the release scenario was established by using API-581 BRD and the effect zone was estimated by the KS-RBI program supporting the quantitative cause analysis. And the risk assessment was performed. As a result, we found that to minimize the damage of a chemical plant, it is effective to use four release hole diameters (small, medium, large and rupture) and release time estimated according to the classes of detection and isolation systems. In addition, it can be safely said that through appling the damage areas considering weighted average by failure frequency and worst-case simultaneously, industrial sites can come up with the effective emergency response plan.
Since the recent slowdown in the smartphone market, studies for wearable devices are briskly being carried out to find new markets, such as virtual reality devices. In this paper, a head-mounted display (HMD) which provides expanded virtual images before human eyes by enlarging images of a small display was designed, and the tolerance analysis method for a focus-adjustable HMD based on afocal optical systems was studied. There are two types of HMDs: a see-through type that allows the user to view the surroundings, and a see-close type where the user can only view the display screen; the former is used in this study. While designing the system, we allowed a lens within the system to be shifted to adjust its focus from +1 to -4 D (diopters). The yield of the designed systems was calculated by taking the worst-case scenario of a uniform distribution into account. Additionally, a longitudinal aberration was used rather than MTF for the tolerance analysis with respect to system performance. The sensitivity of the designed system was calculated by assigning a certain tolerance, and the focus lens shift was calculated to adjust the image surface variations resulting from the tolerance. The smaller the tolerance, the more expensive the unit price of the products. Very small tolerances may even be impossible to fabricate. Considering this, the appropriate tolerance was assigned; the maximum shift of the focus lens in which the image surface can be adjusted was obtained to find the changes in aberration and a good yield.
Veterinary antibiotics (VAs) has been used to treat animal disease and to increase animal weight as growth promoter. However, abused usage of VAs can cause production of antibiotic resistance genes (ARGs) in the environment and additionally, residual of VAs in soil can be transferred into crops. Therefore, main objective of this research was to examine bioaccumulation of VAs in sprouts (red cabbage, Brassica Olearacea L. var. Capitata f. rubra and red radish, Raphanus sativus) with hydroponic method. Total of 7 VAs in 2 different classes of VAs (tetracyclcines: tetracycline, oxytetracycline, chlortetracycline, sulfonamides: sulfamethoxazole, sulfamethazine, sulfamethiazole, macrolides: tylosin) were evaluated and experiment was conducted with solid phase extraction (SPE)/high performance liquid chromatography tandem mass spectrometry (HPLC/MS/MS). Initial spiked concentration of 7 VAs was $5mg\;L^{-1}$ and cultivation period was 8 days. Result showed that growth of sprouts was inhibited about 23-27% when VAs was introduced. Amount of bioaccumulated VAs was also differed depending on class of VAs. The highest amount of bioaccmulated VAs was tetracycline and sulfamethoxazole in each class with a concentration of 4.05, $7.73mg\;kg^{-1}$ respectively. Calculated transfer ratio of VAs into crops was also ranged 0.38-54.27%. Overall, bioaccumulation of VAs in crops can be varied depending on crop species and class of VAs. However, further research should be conducted to verify bioaccumulation of VAs in crops in the soil environment.
Proceedings of the Korea Water Resources Association Conference
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2018.05a
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pp.486-486
/
2018
During the post green revolution era, wheat and rice were the main crops of concern to cater the food security issues of Pakistan. The use of semi dwarf high yielding varieties along with extensive use of fertilizers and surface and ground water lead to substantial increase in crop production. However, the higher crop productivity came at the cost of over exploitation of the precious land and water resources, which ultimately has resulted in the dwindling production rates, loss of soil fertility, and qualitative and quantitative deterioration of both surface and ground water bodies. Recently, during the past two decades, severe climate changes are further pushing the Pakistan's wheat-rice system towards its limits. This necessitates a careful analysis of the current crop water requirements and water footprints (both green and blue) to project the future trends under the most likely climate change phenomenon. This was done by using the FAO developed CROPWAT model v 8.0, coupled with the statistically-downscaled climate projections from the 8 Global Circulation Models (GCMs), for the two future time slices, 2030s (2021-2050) and 2060s (2051-2080), under the two Representative Concentration Pathways (RCPs): 4.5 and 8.5. The wheat-rice production system of Punjab, Pakistan was considered as a case study in exploration of how the changing climate might influence the crop water requirements and water footprints of the two major crops. Under the worst, most likely future scenario of temperature rise and rainfall reduction, the crop water requirements and water footprints, especially blue, increased, owing to the elevated irrigation demands originating from the accelerated evapotranspiration rates. A probable increase in rainfall as envisaged by some GCMs may partly alleviate the adverse impacts of the temperature rise but the higher uncertainties associated with the predicated rainfall patterns is worth considering before reaching a final conclusion. The total water footprints were continuously increasing implying that future climate would profoundly influence the crop evapotranspiration demands. The results highlighted the significance of the irrigation water availability in order to sustain and improve the wheat-rice production system of Punjab, Pakistan.
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