• Toxicological Research
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• v.34 no.2
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• pp.111-125
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• 2018

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.

• Korean Chemical Engineering Research
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• v.58 no.2
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• pp.257-265
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• 2020

Densities (ρ) for binary mixtures of ethanol (1) + diisopropyl ether (DIPE) or cyclohexane or alkane (C₆-C₉) (2) were measured at 298.15 K, 308.15 K and 318.15 K. The excess molar volume (V^E_m) of binary mixtures was calculated using ρ data and correlated with Redlich-Kister polynomial equation. The V^E_m values for binary mixtures of ethanol (1) + cyclohexane or n-alkane (C₆-C₉) (2) were positive, whereas for ethanol (1) + DIPE (2) these were negative. The magnitude of V^E_m values follows the order: cyclohexane > n-nonane > n-octane > n-heptane > n-hexane > DIPE. The V^E_m values have been interpreted qualitatively and also quantitatively in terms of Flory-Treszczanowicz-Benson (FTB) model and Prigogine-Flory-Patterson (PFP) theory. The values V^E_m predicted using FTB model agree well with experimental V^E_m values at all mole fractions. But the PFP theory describes well V^E_m data in ethanol-rich region (x₁ > 0.5) for all binary mixtures and is able to predict the sign of V^E_m vs x₁ curve for ethanol-lean region (x₁ < 0.5) except for ethanol (1) + nonane (2) mixtures.

• Proceedings of the Korean Society of Tribologists and Lubrication Engineers Conference
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• 2002.05a
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• pp.130-134
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• 2002

Polyol esters were synthesized by condensation reaction of polyols (PE and DIPE) and linear acids such as valeric acid, caproic acid, heptylic acid and caprylic acid. The structures of polyol esters were confirmed by gas chromatography. Hot tube test was used to measure thermal stability of polyol esters and its thermal properties depended on the structure of acid moiety contained in polyol esters.

• 한국생물공학회:학술대회논문집
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• 2001.11a
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• pp.621-634
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• 2001

The characteristics of enzymatic methanolysis of castor oil were investigated as a clean technology. Among 16 lipases tested in this study, Novozym 435 showed the highest activity in methanolysis. Solvents had different effects on the methanolysis of castor oil according to weight percent (wt%) of Novozym 435. Heptane showed best activity with 1 wt% of Novozym 435, while isopropyl ether gave the best yield of ricinoleic acid methyl ester with 0.5 wt% of that. Ricinoleic acid methyl ester was obtained in 86% of yield through the methanolysis of castor oil catalyzed by Novozym 435 (1.0 wt%) during 24hr.

• Magazine of the Korean Society of Agricultural Engineers
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• v.18 no.2
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• pp.4089-4095
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• 1976

The safety of shore structure including the sea dipe is largely affected by typhoon. Accordingly it is desirable to analize the typhoon and determine the wind direction and velocity for use in planning and design of the structure. This method was adopted for the design of the Yong San Gang Estuary Dam. A comparative study of the results of typhoon analysis with the meteorological data obtained through actual observation is summarized as follows; (1) 62% of the typhoons occur during May to June in a year, and 62% of the typhoons which have an influence on the Korean peninsula, especially the proposed estuary dam fsite, proceed eastward through the zone in lat. 36$^{\circ}$-37$^{\circ}$N. Such typhoons occur two to three times a year on the average. (2) Data on typhoon "SARL" were used as a model case in designing the estuary dam, where it was proved that a southwesterly wind had a maximum velocity of 30m/sec in case r=150km, ${\alpha}$=120$^{\circ}$. Within the range of 22$^{\circ}$30'on the right and left side of the fetch line of the estuary dam, the wind direction varied SSW\longrightarrowSW\longrightarrowWSW, and the wind velocity varied 29m/sec\longrightarrow30m/sec\longrightarrow125m/sec. Such phenomemum lasted for five hours. (3) An analysis of data obtained during 44 years at Mok Po Meteorological Station shows that a wind with a velocity of some 25m/sec occurred twelve times in the S-direction and two times in the SW-direction, while that with a velocity of 30m/sec occurred three times in the S-direction, three times in the SSW-direction and one time in the SW-direction. The wind which had an influence on the estuary dam had a direction of SSW\longrightarrowSW\longrightarrowWSW and a velocity of min. 30m/sec. Actually, a wind with a max. velocity of 31.3m/sec occurred in the SSW-direction on March 15 and 16, 1956 where the mean velocity during two hours was 28m/sec and that during four hours was 24.6m/sec. (4) The data obtained through actual observation show that when the velocity is low, the wind with a fixed direction lasts long, and when the velocity is high, it is short-lived. It is difficult to determine the velocity of a wind which blows in a fixed direction for consecutive two or four hours. Therefore, the values obtained through typhoon analysis are larger that those obtained through actual observation, and hence, it is resonable to use the analyzed valuse for design of the estuary dam and shore structures. (5) The greatest effect was had on the estuary dam when typhoon was proceeding at a velocity of 29.71m/sec in the direction of ${\alpha}$=120$^{\circ}$(SW) at a point of R=150km from the center of the typhoon.