• Toxicological Research
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• v.19 no.4
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• pp.259-266
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• 2003

Although 'Cinnamon' has been widely used for the food and biophamacy in the world, it's toxicity was not screened completely. Major component of 'cinnamon' is CB-OH and CB-PH. CB-PH has been reported to have antimutagenic effect. To investigate the toxicity of 2-o-Benzoylcinnama-Idehyde (CB-PH), repeated dose (4 weeks) oral toxicity test performed in SD rats. Results of repeated dose oral toxicity tests for 4 weeks (CB-PH; 500, 1000, 2000 mg/kg/day) suggested that the CB-PH treated group showed no significant toxicological findings with body weights, organ weights, hematological and histopathological findings. Therefore, these data indicated that the maximum tolerated dose of CB-PH was 2000 mg above/kg/day in the rats.

• Journal of Pharmacopuncture
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• v.17 no.2
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• pp.18-26
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• 2014

Objectives: This study was performed to check for reversibility in the changes induced by a 13-week, repeated, dose toxicity test of Sweet Bee Venom (SBV) in Sprague-Dawley (SD) rats. Methods: Fifteen male and 15 female SD rats were treated with 0.28 mg/kg of SBV (high-dosage group) and the same numbers of male and female SD rats were treated with 0.2 mL/kg of normal saline (control group) for 13 weeks. We selected five male and five female SD rats from the high-dosage group and the same numbers of male and female SD rats from the control group, and we observed these rats for four weeks. We conducted body-weight measurements, ophthalmic examinations, urinalyses and hematology, biochemistry, histology tests. Results: (1) Hyperemia and movement disorder were observed in the 13-week, repeated, dose toxicity test, but these symptoms were not observed during the recovery period. (2) The rats in the high-dose group showed no significant changes in weight compared to the control group. (3) No significant differences in the ophthalmic parameters, urine analyses, complete blood cell counts (CBCs), and biochemistry were observed among the recovery groups. (4) No changes in organ weights were observed during the recovery period. (5) Histological examination of the thigh muscle indicated cell infiltration, inflammation, degeneration, necrosis of muscle fiber, and fibrosis during the treatment period, but these changes were not observed during the recovery period. The fatty liver change that was observed during the toxicity test was not observed during the recovery period. No other organ abnormalities were observed. Conclusion: The changes that occurred during the 13-week, repeated, dose toxicity test are reversible, and SBV can be safely used as a treatment modality.

• Journal of Haehwa Medicine
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• v.22 no.1
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• pp.171-184
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• 2013

Single-and repeated-dose toxicities of Compound K (CK) were evaluated according to Toxicity Test Guidelines of Korea Food and Drug Administration using Sprague-Dawley rats. For single-dose toxicity study, CK was dissolved in drinking water, orally administered and examined for 14 days. As results, CK up to a dose of 5,000 mg/kg, the limited dose, neither induced death, clinical signs and necropsy findings, nor affected body weight gain and organ weights, in which 10% lethal dose could not be estimated. Based on the results of single-dose toxicity test, CK was administered at doses of 500, 1,000 or 2,000 mg/kg for 28 days for the evaluation of repeated-dose toxicity. All doses including the limited dose (2,000 mg/kg) of CK did not cause any abnormalities of rats, including mortality, clinical signs, body weight gain, feed/water consumption, necropsy findings, organ weights, hematology, blood biochemistry. Rather, high doses (1,000 - 2,000 mg/kg) of CK reduced the serum levels of alanine transaminase (ALT), aspartate transaminase (AST), creatinine phosphokinase (CPK), lactate dehydrogenase (LDH) and triglycerides, in addition to an increase in glucose, indicative of protective effects on hepatic and muscular injuries. Thus, both maximum tolerable dose (MTD) and no observed adverse effect level (NOAEL) were not determined. The results indicate that long-term intake of high-dose CK might not induce general adverse effects.

• Proceedings of the Korea Society of Environmental Toocicology Conference
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• 2002.10a
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• pp.172-172
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• 2002

Previously, we reported a novel polymeric micellar solubilizer, Aceporol 330, that showed relatively low toxic effects when it was compared with that of Cremophor EL which is currently being used for paclitaxel. In this study, we have developed a new micellar solubilizer, Aceporol 460, that has 3-4 times higher loding capacity for paclitaxel than Aceporol 330. The single-dose and the repeated-dose toxicity of Aceporol 460 were evaluated in ICR mice. For single dose toxicity test, male and female mice were randomly assigned to one of five study groups to receive, and injected intravenously with dosages of 0, 3, 4mL Cremophor EL/kgbody weight, and 3, 4mL Aceporol 460/kg body weight, respectively. In both male and female mice, LD50 for Aceporol 460 can not he determined even at the maximal administrable dosage, 4mL/kg due to the high viscosity of chemical and there was no significant change in body weight, hematological and serum biochemical analysis, organ weight, and histopathological examination compared with that of Cremophor EL. For the repeated dose toxicity test, male and female mice were given the dosage of 0, 1.6mL Cremophor EL/kgbody weight/day, and 1.6mL Aceporol 460/kg body weight/day for 2 weeks. Results of repeated dose toxicity tests for 2 weeks suggested that Aceporol 460 treated group show no significant toxicological findings with body weight, hematological and serum biochemical analysis, organ weight, urinalysis, and ophthalmoscopic and histopathological examination compared with that of Cremophor EL. These results indicate that Aceporol 460 have higher paclitaxeL-loading capacity than Aceporol 330 and less toxic effects than Cremophor EL in male and female mice.

• Radiation Oncology Journal
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• v.34 no.3
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• pp.209-215
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• 2016

Purpose: We sought to determine if organ preservation (OP) with neoadjuvant chemoradiation (CRT) was feasible in patients with sinonasal cancer determined to require exenteration. Materials and Methods: Twenty patients were determined to require exenteration for definitive treatment from 2005 to 2014. Fourteen patients underwent OP and 6 patients received exenteration with adjuvant CRT. Exenteration free survival (EFS), locoregional control (LRC), progression-free survival (PFS), and overall survival (OS) were estimated. Results: Five patients (36%) receiving OP had complete disease response at time of surgery. With a median follow-up of 18.8 months, EFS was 62% at 2 years for patients undergoing OP. At 2 years, there were no significant differences in LRC, PFS or OS (all all p > 0.050) between the groups. Less grade 3 or greater toxicity was seen in patients undergoing OP (p = 0.003). Visual function was preserved in all patients undergoing OP. Conclusion: For patients with sinonasal cancer, OP may avoid exenteration, offering similar disease control and improved toxicity.

• Toxicological Research
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• v.27 no.4
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• pp.261-267
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• 2011

Artemisia iwayomogi, a member of the Compositae, is a perennial herb easily found in Korea and used as a traditional medicine to treat liver disease. AIP1, a water-soluble carbohydrate fraction from Artemisia iwayomogi, showed anti-tumor and immuno-modulating activities in animal studies. A subacute toxicological evaluation of AIP1 was performed for 4 weeks in ICR mice. After administration of AIP1 (0, 20, 100, 500 mg/kg/day), the clinical signs, mortalities, body weight changes, hematology, blood clinical biochemistry, urinalysis, organ histopathology, organ weights and gross finding were examined. The results showed that there were no significant differences in body weight changes, food intakes, water consumptions, or organ weights among different dose groups. Also we observed no death and abnormal clinical signs during the experimental period. Between the groups orally treated with AIP1 and the control group, there was no statistical significance in hematological test or serum biochemical values. Histopathological examination showed no abnormal changes in AIP1 groups. These results suggest that no observed adverse effect level (NOAEL) of the oral administration of AIP1 for 4 weeks was considered to be more than 500 mg/kg/day in mice under the condition investigated in current study.

• Toxicological Research
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• v.24 no.1
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• pp.79-86
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• 2008

This study was conducted to obtain information of the oral dose toxicity of low molecular fucoidan (LMF) in male and female mice. In order to calculate 50% lethal dose ($LD_{50}$) and approximate lethal dose (LD), test material was once orally administered to male and female ICR mice at dose levels of 2000, 1000, 500, 250, 125 and 0 (vehicle control) mg/kg (body wt.). The mortality and the changes on body weight, clinical signs, gross observation and organ weight and histopathology of principle organs were monitored 14 days after LMF treatment. We could not find any mortalities, clinical signs, body weight changes and gross findings. In addition, significant changes in the organ weight and histopathology of principal organs were not observed except for some sporadic findings. The results obtained in this study suggest that LMF may not be toxic in mice and may be therefore safe for clinical use. The $LD_{50}$ and approximate LD in mice after single oral dose of LMF were considered over 2000 mg/kg in both female and male mice.

• Journal of Physiology & Pathology in Korean Medicine
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• v.27 no.3
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• pp.299-305
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• 2013

This study was to evaluate the single dose toxicity of Arecae Semen (AS) in male and female ICR mice. Aqueous extracts of AS (Yield = 13.15%) were administered as an oral dose of 2,000, 1,000 and 500 mg/kg (body weight) according to the recommendation of Korea Food and Drug Administration (KFDA) guidelines. Animals were monitored for the mortality and changes in body weight, clinical signs and gross observation during 14 days after dosing, upon necropsy; organ weight and histopathology of 12 principle organs were examined. We could not find any mortality, clinical signs, and changes in the body and organ weight except for diarrhea. Diarrhea were observed in all three different dosage groups of male mice, and in 2000 mg/kg groups of female mice within 48hrs after administration. In addition, no AS extract related abnormal gross findings and changes in histopathology of principle organs were detected except for some sporadic accidental findings. Although the 50% lethal dose and approximate lethal dose of AS aqueous extracts in female and male mice were detected as over 2,000 mg/kg - the limited highest dosage recommended by KFDA guidelines. It should be carefully used in clinics because AS may be induced severe digestive tract disorders.

• Biomolecules & Therapeutics
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• v.17 no.3
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• pp.325-331
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• 2009

The object of this study was to evaluate the single oral dose toxicity of Low Molecular Weight Fucoidan (LMF) in male and female rats. LMF was administered to female and male SD rats as an oral dose of 2,000, 1,000 and 500 mg/kg (body wt.). Animals were monitored for the mortality and changes in body weight, clinical signs and gross observation organ weight and histopathology of 14 principle organs were examined upon necropsy. As the results, no LMF treatment related mortalities, clinical signs, changes on the body and organ weights, gross and histopathological observations against 14 principle organs were detected up to 2,000 mg/kg in both female and male rats except for some sporadic findings not LMF treatment related toxicological signs. Therefore, $LD_{50}$ (50% lethal dose) and approximate LD of LMF after single oral treatment in female and male rats were considered over 2,000 mg/kg - the limited dosages recommended by KFDA Guidelines [2005-60, 2005], respectively.

• Toxicological Research
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• v.25 no.3
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• pp.147-157
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• 2009

This study was conducted to obtain acute information of the oral dose toxicity of lyophilized water extract of Pinelliae Rhizoma, a dried tuber of Pinellia ternata (PR) in male and female mice. In order to calculated 50% lethal dose (LD$_{50}$) and approximate lethal dose (ALD), test material was once orally administered to male and female ICR mice at dose levels of 2000, 1000, 500, 250, 125 and 0 (vehicle control) ml/kg (body weight). The mortality and changes in body weight, clinical signs, gross observation, organ weight and histopathology of principle organs were monitored 14 days after treatment with PR extract. We could not find any mortalities, clinical signs, changes in the body and organ weights, gross and histopathological findings except for dose-dependent increases in the hepatic fatty change frequencies detected in PR extract 2000 and 1000mg/kg treated in both male and female mice. The results obtained in this study suggest that LD$_{50}$ and approximate LD in mice after single oral dose of PR extracts were considered over 2000 mg/kg in both and female male mice, but more than 1000mg/kg of PR extracts treatment could induce slight hepatotoxicity the fatty changes in mice.