• 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.

• Fisheries and Aquatic Sciences
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• v.27 no.2
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• pp.66-75
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• 2024

Heavy metals are naturally found in the ecosystem, and their presence in the freshwater river is increasing through anthropogenic activities which pose a threat to living beings. In this study, heavy metal concentrations (Zn, Mn, Cu, Cd, Cu, Cr, Pb, and Ni) in different organs (muscle, skin, and gill) of fish from the Padma River were evaluated to quantify, and compare the contamination levels and related human health risks. The results revealed that the heavy metal concentrations in the water, surface sediments, and fish taken from the Padma River were far below the WHO/USEPA's permitted limits. The estimated daily intake (EDI) value in muscle was less than the tolerable daily intake (TDI). The target hazard quotient (THQ) and hazard indexes (HI) were less than 1, showing that consumers face no non-carcinogenic risk (CR). CR values of Cu, Cd, Cr, Pb, and Ni ranged from 4.00 × 10^-8 to 6.35 × 10^-6, less than 10^-4, and total carcinogenic risk (CRt) values ranged from 9.85 × 10^-6 to 1.10 × 10^-5, indicating some pose a CR from consumption of those fish from the Padma River. To establish a more accurate risk assessment, numerous exposure routes, including inhalation and cutaneous exposure, should be explored.

• Food Science of Animal Resources
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• v.40 no.5
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• pp.675-688
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• 2020

Polycyclic aromatic hydrocarbons (PAHs) are dangerous chemical compounds that can be formed by cooking foods at high temperatures. The aim of this study is to determine the level of contamination of PAH compounds with high performance liquid chromatography (HPLC) on heat treated meat samples and the consumption of PAH compounds in meat samples, as well as the dietary exposure status and possible health risk estimation. In five different heat treated meat samples (meat doner, chicken doner, meatballs, grilled chicken, and fish), the total PAH (Σ16PAH) contamination level was 6.08, 4.42, 4.45, 4.91, and 7.26 ㎍/kg, respectively. Benzo[a]pyrene (BaP) in meatballs and grilled fish samples had a level 0.70 and 0.73 ㎍/kg. All of the samples analyzed were found to be below the EU permitted limit (5 ㎍/kg) in terms of BaP. Estimates of daily intake (EDI) for a total of 16PAH in heat treated meat doner, chicken doner, meatballs, grilled chicken and fish samples were 3.41, 3.71, 2.49, 4.12, and 1.77 ng/kg bw/day, respectively. In this study, the average margin of exposure (MOE) value calculated was found in the range of 179.487 and 425.000 for BaP and PAH4. This study is the first study to provide important information in terms of evaluating the possible health risk that PAH compounds can create in people's diets due to heat treatment of meat and meat products in Sivas, Turkey.

• Journal of Radiation Industry
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• v.5 no.4
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• pp.337-345
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• 2011

In order to provide an effective preparedness for a nuclear or radiological emergency happening in the domestic or neighborhood countries and to solve the vague fear of the people for the ingestion of radioactive livestock products, the establishment of national guideline level for radionuclides in feed is urgently necessary. This is because it is important to secure the safety and to manage the crisis in the agricultural, fishery and food sector by performing the effective safety control during and after nuclear incident. This study was performed to investigate the report cases of international organizations and foreign countries to set up a domestic control standard for managing radioactive substances that may be contaminated in animal feeds due to the nuclear power plant incident. In addition, an attempt was made to provide a useful reference that can help prepare a domestic control standard, using a coefficient that can consider the transfer into livestock through the intake of radioactive contaminated animal feeds. The standard radioisotopes investigated were confined to radioactive cesium ($^{137+134}Cs$) and iodine ($^{131}I$). Guideline level for the radionuclides was calculated by using the transfer coefficient factor and the maximum daily intake of animal feed provided by IAEA. For example, the maximum daily intake of animal feed was set as $25kg\;d^{-1}$ for dairy cows, $10kg\;d^{-1}$ for beef cattle, $3.0kg\;d^{-1}$ for pigs and $0.15kg\;d^{-1}$ for chickens. The result values for radioactive cesium were calculated as $8,696Bq\;kg^{-1}$, $4,545Bq\;kg^{-1}$, $1,667Bq\;kg^{-1}$ and $2,469Bq\;kg^{-1}$, respectively. The results for radioactive iodine showed the ranges between $741Bq\;kg^{-1}$ and $76,628Bq\;kg^{-1}$. These data can be utilized as a scientific reference for the preparation of a crisis management manual for the emergency control due to nuclear power plant accident in Korea and neighboring country. These results will contribute to establish the safe feed management system at national level as manual for responding the radioactive exposure of agricultural products and animal feeds, which are currently not established.

• Journal of Food Hygiene and Safety
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• v.26 no.4
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• pp.315-321
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• 2011

This study was performed to investigate contamination levels of aflatoxins, the secondary metabolites produced by fungi Aspergillus flavus and A. parasiticus, in herbal medicine. Herbs is susceptible to these fungi infections through its growth harvest, transport and storage. This study determine the aflatoxin $B_1$, $B_2$, $G_1$ and $G_2$ levels by HPLC-florescence detector coupled with photochemical enhancement in 558 samples herbal medicine distributed in Korea and China. Also, We checked a transfer ratio of aflatoxins from raw herbal medicines to herbal medicine extract. Hot water extraction of herbal medicines was prepared by air pressure and high pressure condition. The analytical method for aflatoxins was validated in this method. In results recoveries of the analytical method were ranged from 67.4% to 96.2% and, limits of detection and quantitation for aflatoxins were $0.015{\sim}0.138\;{\mu}g/kg$ and $0.046{\sim}0.418\;{\mu}g/kg$, respectively. According to the results of monitoring on aflatoxins in herbal medicine, aflatoxins 1.7 ug/kg $B_1$ and 0.9 ug/kg $G_1$ were detected in only one sample of Strychni Ignatii Semen, and 0.8 ug/kg $G_1$ in Strychni Semen. About 13.6~51.3% of aflatoxins were transferred to hot water extract. Although the detected levels are under the permitted levels for aflatoxins in herbal medicine, these amounts should be considered in regard to overall daily exposure to mycotoxins.