• 대한본초학회지
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• 제39권3호
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• pp.107-114
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• 2024

Objective : Cicadae Periostracum (CP), which is the discarded shell of the Cryptotympana atrata (Fabricius, 1775), is a recognized component of oriental medicine for treatment sore throat, itching, shock, sedation, edema. However, the safety and toxicity of CP have not yet been established. It has been reported that symptoms of addiction or side effects may occur in patients who take high doses of CP or who are hypersensitive to it. Therefore, we investigated the acute toxicity of an CP extracts in Sprague-Dawley (SD) rats. Methods : To study acute toxicity, five SD rats of each sex per group were treated with CP extracts at single doses of 0, 500, 1000, or 2000 mg/kg administrated by oral gavage, and body weight, clinical signs, and mortality were observed after dosing. At the end of 14-day observation period, all animals were sacrificed and complete hematological and macroscopic examinations were performed. Results : There were no dead animal and test article-related effects on body weight change or the gross finding. No toxicologically significant results were observed between control and treated groups in hematology. Although salivation related to stress at the highest dose was observed in clinical signs immediately after administration, it is considered to have no toxicological significance. Conclusion : As the results, we did not find any adverse effect at the dose levels of 500, 1000, or 2000 mg/kg in rats. The minimal lethal dose was considered to be over 2000 mg/kg body weight in rats.

• Toxicological Research
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• 제35권2호
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• pp.181-190
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• 2019

Lentinus squarrosulus (Mont.) is an edible wild mushroom with tough fruiting body that belongs to the family Polyporaceae. It is used in ethnomedicine for the treatment of ulcer, anaemia, cough and fever. Recent studies have demonstrated its anticancer, anti-diabetic and antioxidant properties. However, little or no information is available regarding the bioactive components and toxicological study of wild dried L. squarrosulus. Therefore, this study investigated the bioactive components of aqueous extract of boiled wild dried L. squarrosulus and its toxicological effects in rats. The extract of L. squarrosulus was subjected to GC-MS analysis. The acute toxicity test was performed by oral administration of a single dose of up to 5,000 mg/kg extract of L. squarrosulus. In subacute study, the rats were orally administered extract of L. squarrosulus at the doses of 500, 1,000 and 1,500 mg/kg body weight daily for 14 days. The haematological, lipid profile, liver and kidney function parameters were determined and the histopathology of the liver and kidney were examined. The GC-MS analysis revealed the presence of bioactive compounds; 1-tetradecene, fumaric acid, monochloride, 6-ethyloct-3-yl ester, 9-eicosene, phytol, octahydropyrrolo[1,2-a]pyrazine and 3-trifluoroacetoxypentadecane. In acute toxicity study, neither death nor toxicity sign was recorded. In the sub-acute toxicity study, significant differences (p < 0.05) were observed on creatinine, aspartate aminotransferase, alanine aminotransferase, total cholesterol, triglycerides and high-density lipoprotein cholesterol. Whilst no significant differences (p > 0.05) were observed on packed cell volume, heamoglobin, red blood cell, white blood cell and alkaline phosphatase, in all the tested doses. No histopathological alterations were recorded. Our findings revealed that aqueous extract of L. squarrosulus may have antimicrobial, antinocieptive and antioxidant properties based on the result of GC-MS analysis. Results of the toxicity test showed no deleterious effect at the tested doses, suggesting that L. squarrosulus is safe for consumption at the tested doses.

• Preventive Nutrition and Food Science
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• 제11권2호
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• pp.115-119
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• 2006

The object of this study was to examine whether the germanium fortified yeast administered to SD rat is accumulated in the liver and kidney. The administration doses were within 2,000 mg/kg which is the level of NOAEL (no observed adverse effect level) proved through the previous study of single/consecutive oral toxicity test. There were no significant clinical symptoms and mortality following the administration of organic germanium-fortified yeast (0, 500, 1,000, 2,000 mg/kg) during the whole test period, and also no difference in the consumed amount of feed and water for each group. No significant abnormalities of hematology and blood chemistry parameters were found in all groups of organic germanium-fortified yeast (0, 500, 1,000, 2,000 mg/kg). The amount of germanium accumulated in liver and kidney was 0 g/kg by ICP-AES method in the group of organic germanium-fortified yeast. In the positive control group of $GeO_2$ (150 mg/kg), the amount of accumulation was shown to 3135.0 and 4277.2 g/kg in each female and male kidney and 1044.3 and 2135.8 g/kg in each female and male liver, respectively. Organic germanium-fortified yeast, a biosynthetic product resulting from putting germanium into yeast, did not show any clinical symptoms, blood chemical significance, and residues in kidney and liver. It could be inferred that the non-toxic amount of organic germanium-fortified yeast was up to 2,000 mg/kg.

• 한국식품영양과학회지
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• 제42권6호
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• pp.892-897
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• 2013

본 연구는 김치로부터 항진균 활성을 보이는 유산균인 Lactobacillus(Lb.) plantarum AF1이 생산하는 조항진균 물질의 부분 정제물이 천연 식품보존제 및 사료보존제로서 사용 가능성을 알아보기 위하여 안전성을 평가하고자 단회 급성독성시험을 실시하였다. 급성독성시험을 위하여 경구로 1회 시험물질을 최고 용량(2,000 mg/kg)으로 하여 ICR계통 암수 마우스에게 용량별 각 군당 10 마리씩 투여한 후 14일간의 일반증상, 사망률, 체중, 임상증상 및 육안적 소견을 관찰하였다. 단회 경구투여한 후 모든 시험군에서 사망례가 관찰되지 않았으며, 시험동물은 시험 종료 시까지 계속 생존하여 평균치사량을 산출할 수 없었다. 경구투여한 후 마우스의 체중변화에 있어서도 암수 모두 대조군과 시료물질 투여군 사이에 유의성 있는 차이는 보이지 않았으며, 용량 의존적인 차이도 볼 수 없었다. 경구투여한 후 시험 종료한 다음 생존동물 모두를 부검하여 주요 장기의 육안적 소견을 관찰한 결과 대조군과 시료투여군 모두에서 외관상이나 내부 장기에 어떠한 이상소견이나 병변이 관찰되지 않았다. 이상의 결과로부터 시험물질인 Lb. plantarum AF1이 생산한 조항진균 물질을 경구투여 시 ICR계통 암수 마우스에서 독성학적인 변화가 관찰되지 않았으며, $LD_{50}$은 경구투여 시 2,000 mg/kg 이상인 저독성의 안전한 물질로 사료된다.

• 생명과학회지
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• 제24권2호
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• pp.191-195
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• 2014

오미자(Schizandra chinensis Baillon., Schisandrae Semen)의 열매는 한국을 포함한 아시아 지역에서 오랫동안 전통 의약제로 광범위하게 사용되어 왔다. 식물에서 분리된 정유(essential oils)는 다양한 약리효능을 지니고 있지만, 오미자 열매에서 추출한 정유의 약리학적 기전은 밝혀진 바 없다. 본 연구에서는 오미자 종자의 정유(Schisandrae Semen essential oil, SSeo)에 대한 안정성을 확보하기 위하여 단회경구투여 독성시험을 ICR 마우스를 대상으로 실시하였다. SSeo은 ICR mice에 5,000 mg/kg 농도로 경구 투여하였으며, 14일 후 희생시켰다. SSeo 투여 후 치사율, 임상 증상, 체중 및 부검 소견 상의 유의적인 변화는 관찰되지 않았다. 또한 각 장기의 무게, 혈액학적 및 혈청학적 임상 화학적 지표에도 총 bilirubin량을 제외한 유의적인 변화는 관찰할 수 없었다. 따라서 SSeo 단회 투여에 따른 치사량은 5,000 mg/kg 이상일 것으로 추정되어 급성 독성 측면에서 유해성이 없다는 의미를 지니며, 경구투여에 따른 어떤 부작용도 나타내지 않았음을 의미한다.

• 동의생리병리학회지
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• 제24권1호
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• pp.134-142
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• 2010

Although BinSo-San(BSS), a mixed herbal formula consisted of 11 types of medicinal herbs and have been used as anti-inflammatory agent, In the present study, the acute toxicity (single oral dose toxicity) of lyophilized BSS aqueous extracts was monitored in male and female mice after oral administration according to Korea Food and Drug Administration (KFDA) Guidelines (2005-60, 2005). In order to observe the 50% lethal dose ($LD_{50}$), approximate lethal dosage (ALD), maximum tolerance dosage (MTD) and target organs, test articles were once orally administered to female and male ICR mice at dose levels of 2000, 1000, 500, 250 and 0 (control) mg/kg (body wt.) according to the recommendation of KFDA Guidelines (2005-60, 2005). The mortality and changes on body weight, clinical signs and gross observation were monitored during 14 days after dosing according to KFDA Guidelines (2005-60, 2005) with organ weight and histopathology of 12 types of principle organs. We could not find any mortality, clinical signs and changes in the body weights except for dose-independent increases of body weight and gains restricted in 1000 mg/kg of BSS extracts-dosing female group. Hypertrophic changes of lymphoid organs.thymus, spleen and popliteal lymph nodes were detectedat postmortem observation with BSS extracts dose-dependent increases of lymphoid organ weights, and hyperplasia of lymphoid cells in these all three lymphoid organs at histopathological observations. These changes are considered as results of pharmacological effects of BSS extracts or their components, immunomodulating effects, not toxicological signs. In addition, some sporadic accidental findings such as congestion spots, cyst formation in kidney, atrophy of thymus and spleen with depletion of lymphoid cells, and edematous changes of uterus with desquamation of uterus mucosa as estrus cycles were detected throughout the whole experimental groups including both male and female vehicle controls. The significant (p<0.01) increases of absolute weights of kidney and pancreas detected in BSS extracts 1000 mg/kg-treated female group are considered as secondary changes from increases of body weights. The results obtained in this study suggest that the BSS extract is non-toxic in mice and is therefore likely to be safe for clinical use. The LD50 and ALD of BSS aqueous extracts in both female and male mice were considered as over 2000 mg/kg because no mortalities were detected upto 2000 mg/kg that was the highest dose recommended by KFDA and OECD. In addition, the MTD of BSS extracts was also considered as over 2000 mg/kg because no BSS extracts-treatment related toxicological signs were detected at histopathological observation except for BSS or their component-related pharmacological effects, the immunomodulating effects detected in the present study.

• 동의생리병리학회지
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• 제19권5호
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• pp.1200-1203
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• 2005

Kami-Okchun-San(OCS) is known as an effective herbal medicine on Type 2 diabetes. We peformed to investigate acute toxicity of OCS on ICR mice. ICR mice in acute toxicity experiment were administered orally with dosages of 3,200mg/kg (low dosage group), 4,000mg/kg (middle dosage group), 5,000mg/kg (high dosage group) per single time, respectively. Body weights, clinical signs, motalities and histopathological finding were observed daily for 14 days according to the Regulation of Korean Food and Drug Administration(1999. 12. 22). Single oral administration of OCS with different dosages, no animals died of the test drug. Autopsy of animal revealed no abnormal gross findings. Therefore, LD50 value of OCS for ICR mice was more than 5,000mg/kg on oral route. Normally increasing changes were observed in body weight, drinking water and food intake in every dosage group. Hematological parameters were also observed normally in all animals. No histopathological lesions were observed in both control and treated animals. Above data suggest that no toxic dose level of OCS in ICR mice is considered to be more than 5,000mg/kg. Therefore, it was concluded that OCS have no effect on acute toxicity and side effect in ICR mice.

• 한국식품영양과학회지
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• 제38권10호
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• pp.1324-1330
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• 2009

생강나무는 한국, 일본, 중국 등지에서 자생하며 열, 복통, 타박상, 출혈 등에 민간요법으로 사용되어온 식물이다. 이 논문의 목적은 오래전부터 민간요법으로 사용되어온 생강나무 잎의 안전성을 평가하고자 생강나무 잎 70% 에탄올 추출물을 암수 각 군당 5마리씩 5000(단회투여 독성시험), 0, 500, 1000, 2000(14일 반복투여 독성시험) mg/kg의 용량으로 단회경구투여와 14일 반복경구투여를 실시하여 15일간의 사망률, 일반증상, 체중변화, 조직병리, 혈액학적 및 혈액 생화학적 검사를 실시하였다. 시험기간 중 사망동물은 암수 모든 시험군에서 관찰되지 않았으며, 일반증상, 체중변화, 조직병리, 혈액학적 및 혈액생화학적 검사에서 투여와 관련된 변화는 관찰되지 않았다. 이상의 결과로 보아 생강나무의 단회투여 독성은 5000 mg/kg 용량을 상회하며, 14일 반복투여의 최고용량인 2000 mg/kg 용량에서도 아무런 독성이 나타나지 않는 것으로 보아 최대무독성량은 이 농도를 상회하는 것으로 판단된다. 이로써 생강나무는 안전한 소재로서 식재료 또는 건강기능식품의 원료로서도 사용이 가능하다고 볼 수 있다.

• 한국독성학회:학술대회논문집
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• 한국독성학회 2003년도 추계학술대회
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• pp.133-133
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• 2003

In recent years. attention has focused on the application of the alkaline single cell gel electrophoresis (SCGE or Comet) assay in environmental mutagenesis. To evaluate the suitability of the assay as a monitoring. technique, the DNA damages in liver cells and erythrocytes of carp (Cyprinus carpio) exposed to benzo[${\alpha}$]pyrene (B[${\alpha}$]P) were estimated comparatively with the in vivo Comet assay and the micronucleus test (MNT).(omitted)

• 생명과학회지
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• 제26권10호
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• pp.1207-1213
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• 2016

오미자(Schisandrae Fructus)와 상엽(Mori folium)은 한국, 중국, 일본을 포함한 아시아 지역에서 오랫동안 식품자원 및 전통 의약제로 광범위하게 사용되어 왔다. 최근 연구에 따르면 오미자와 상엽은 항균, 항염증, 항산화, 면역기능 조절 및 혈관신생억제 등과 같은 많은 효능을 가지는 것으로 알려져 있다. 그러나 오미자(SF), 상엽(MF) 에탄올 단독추출물 및 복합추출물(medicinal herber mixture, MHMIX)에 대한 독성 및 안전성에 대해서는 거의 알려져 있지 않은 실정이다. 따라서 본 연구에서는 SF, MF 및 MHMIX가 유발하는 급성독성 및 안전성을 확인하였다. 이를 위하여 ICR mice를 대상으로 SF, MF 및 MHMIX 5,000 mg/kg을 최고농도로 설정하여 단회 경구 투여하였으며, 투여 후 14일 동안의 치사율, 체중 변화, 임상증상, 음수율 및 사료섭취량과 함께 부검 소견, 장기무게 변화, 혈액학 및 혈액생화학적 검사를 실시하였다. 결과에서 나타난 바와 같이 SF, MF 및 MHMIX의 투여 후 치사율, 임상증상, 체중 및 부검 소견 상의 유의적인 변화는 관찰되지 않았다. 또한 SF, MF 및 MHMIX 투여에 따른 각 장기의 무게, 혈액학적 및 혈청학적 임상 화학적 지표에도 유의적인 변화는 관찰할 수 없었다. 따라서 SF, MF 및 MHMIX는 단회 경구 투여에 따른 치사량이 5,000 mg/kg 이상일 것으로 추정되어 ICR 마우스에 대하여 급성독성이 없는 비교적 안전한 물질이라는 것을 알 수 있었으며, 향후 천연물 소재로서의 효능 규명을 통한 활용이 기대된다.