• Toxicological Research
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• 제18권3호
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• pp.285-292
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• 2002

The repeated toxicity of Gleditschia-saponin produced and provided by S.S. Bio-Tech Bench Co. was evaluated in Sprague-Dawley rats. Gleditschia-saponin was administered to rats by oral route at dose levels of high (180 mg/kg/day), medium (90 mg/kg/day) and low (45 mg/kg/day) once a day for 14 days. Saline was administered to another group of rats as control. Each group was consisted of 5 male and female rats. There were no dose-related changes in clinical findings, food and water consumption, organ weights, urine analysis, biochemical examination and hematological findings in all groups of animals treated with Gleditschia.- saponin, except body weights. Body weighs in male and female rats were increased significantly (p < 0.05) from day 4 to 14 in low, middle and high dose groups than control group. Body weight in high dose group was increased higher than control or low, middle dose groups on day 14. Gross and histopathological findings revealed no evidence of specific toxicity to Gleditschia.-saponin. Therefore, it was concluded that Gleditschia-saponin had no toxic or side effects in Sprague-Dawley rats in an repeated oral toxicity tests.

• 한방비만학회지
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• 제18권1호
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• pp.36-49
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• 2018

Objectives: The study is aimed at evaluating the possible toxicity in 90-day repeated oral administration of modified Samjung-hwan (mSJH) in Sprague-Dawley (SD) rats. This study was conducted to detect the no-observed adverse effect level (NOAEL). Methods: Modified SJH extract was administered orally in male and female SD rats at dose of 0, 1,000, 2,000, 4,000 mg/kg. Each group consisted of 10 rats of each gender. The modified SJH extract was given once a day for 90 days. We monitored the changes of mortalities, clinical signs, body weight changes, food consumption, ophthalmologic findings, urine analysis, hematology, serum biochemistry, necropsy findings, organ weights, histological markers of all animals treated with modified SJH extract during the study period. Results: There were no toxicologically significant changes in mortalities, clinical signs, body weight gains, food consumption, ophthalmologic findings, urine analysis, hematology, serum biochemistry, necropsy findings, organ weights, histological markers in any of rats tested. Conclusions: The NOAEL of the modified SJH extract in male rats and no observed effect level (NOEL) in female rats are considered 4,000 mg/kg.

• 생명과학회지
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• 제26권10호
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• pp.1153-1162
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• 2016

계종버섯(Thermitomyces albuminosus)의 안정성을 입증하기 위하여 사료에 계종버섯의 분말을 5%, 2.5%, 1.25%, 0%를 혼합하여 90일 동안 랫드에 자유 급이 시켜 실험동물의 일반증상, 체중변화, 혈액학적 검사, 부검소견, 임상병리, 조직병리학적 검사의 결과를 토대로 독성을 평가하였다. 독성판정기준은 독성의 정도와 양상에 따라 weight-based classification (독성 강도에 따른 분류)로 분류 하였는데 비시험물질-유래 변화인 NOEL, 시험물질-유래 경미한 변화는 NOAEL, 시험물질-유래 중요한 변화는 LOAEL을 기준으로 나누었다. 시험결과, 수컷 좌, 우측 신장 중량이 용량의존적으로 증가하여 고용량군에서는 12%, 8% 증가 하였다. 하지만 임상, 조직병리학적 결과 독성으로 판단되는 소견이 관찰되지 않아 시험물질-유래 경미한 변화로 판단으로 분류하였다. 따라서 판정기준에 따라 수컷은 NOAEL 암컷은 NOEL이 식이함량 5%로 추정되지만 식약처고시에 따라 암수 모두 NOAEL이 식이함량의 5%로 추정할 수 있다. 따라서 계종버섯은 식품 또는 기능성식품으로의 개발에 문제가 없을 것으로 사료된다.

• Toxicological Research
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• 제35권1호
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• pp.65-74
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• 2019

Tetrahydrocurcumin (THC) is a major metabolite of curcumin, which is obtained from Curcuma longa. THC has various benefits and overcomes the bioavailability issue of curcumin. To establish it as a pharmacologically active molecule, its safety profile has to be determined. Thus, the present study aimed to determine the preclinical safety profile of THC in a 90-day subchronic and reproductive/developmental toxicity study in Wistar rats. THC at oral doses of 100, 200, and 400 mg/kg was administered daily for 90 days. Rats in the recovery group were kept for 14 days after treatment termination. The animals were observed for treatment-related morbidity, mortality, and changes in clinical signs, clinical pathology, and histopathology. In the reproductive/developmental toxicity study, THC at 100, 200, and 400 mg/kg was administered orally to rats and the reproductive/developmental parameters in adult male and female rats and pups were observed. THC at up to 400 mg/kg/day of did not have any significant effect on all parameters in male and female rats in both toxicity studies. Thus, 400 mg/kg/day can be considered as the no-observed-adverse-effect-level of THC in rats.

• 한국수산과학회지
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• 제47권4호
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• pp.356-362
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• 2014

Phlorotannins, the major constituent in brown algae, possess various biological activities; however, there is little information their toxicological effects. To assess the safety of phlorotannins, we investigated the acute oral toxicity of a high-purity phlorotannin preparation (PRT; total phlorotannin content 90%) in beagle dogs. Six beagle dogs (3 males, 3 females) were assigned randomly to three experimental groups. PRT was administered at oral doses of 250, 500, and 750 mg/kg by capsule. Vomiting by male and female beagles was observed with 500 and 750 mg/kg on the first day. In addition, one beagle given 750 mg/kg had soft stool and diarrhea on days 3 and 13. No deaths or abnormal clinical signs were observed during the experiment. All groups showed similar body weight gain and food consumption. Our acute toxicity study showed that PRT did not cause any toxicological effects in beagle dogs.

• 한방안이비인후피부과학회지
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• 제27권1호
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• pp.79-90
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• 2014

Objectives : This study was carried out to evaluate the repeated dose oral toxicity of Alismatis Rhizoma in Sprague-Dawley(SD) rats. Methods : Male and female rats were administered orally with Alismatis Rhizoma water extract of 500 mg/kg(low dosage group), 1,000 mg/kg(middle dosage group) and 2,000 mg/kg(high dosage group). We daily observed number of deaths, clinical signs and gross findings for 14 days(twice a day). After 14 days, we measured body and organs weight. Also we analyzed hematological changes. Results : No dead SD rats and no clinical signs were found during the experiment period. Also other specific changes were not found between control and treated groups in hematology and serum biochemistry. In addition no significant changes of gross body and individual organs weight. Conclusions : These results suggest that water soluble extract of Alismatis Rhizoma has not repeated dose oral toxicity and oral LD50 value was over 2,000 mg/kg in SD rats. As a result, we can determine Alismatis Rhizoma is a relatively safe substance.

• Natural Product Sciences
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• 제14권2호
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• pp.122-126
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• 2008

Chronic oral toxicity studies (90 days) on aqueous and methanol extracts of the whole plant of Peristrophe paniculata (Forssk) Brummitt were carried out in Wistar rats. The dosage was 200 mg/kg/day, p.o. for both the extracts. All external morphological and biochemical changes, in addition to body weight and vital organ weights were recorded. During this investigation, no significant mortality was observed. The results showed that both the extracts were devoid of any toxicity at the dose level studied as compared to the control group.

• 대한한의학방제학회지
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• 제31권4호
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• pp.327-339
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• 2023

Objectives : This study conducted a repeated dose 90-day oral toxicity test in order to up-cycling Schisandra fruit extract powder(SFEP) using discarded Schisandra chinensis by-products and evaluated the NOAEL of SFEP. Methods : SD-rats were orally administered SFEP at concentrations of 0, 62.5, 125, and 250 mg/kg once daily for 90 days. Body weights and clinical signs were observed during the administration period. After completion of the experiment, the experimental animals were autopsied to observe necropsy findings and organ weights changes, and hematological parameters and blood chemistry values were measured. Results : During the SFEP administration period, clinical signs such as salivation, wounds, and erosion were sporadically observed in 1 to 2 animals. In the SFEP 250 mg/kg administered group, weights of the liver and thyroid gland significantly increased compared to the control group, but no significant changes were observed in organ weights according to body weights. As a result of measuring hematological parameters and blood chemistry values, a decrease in RDW, T-BIL, and TBA, and an increase in TP, ALB, and Ca were observed due to SFEP administration. However, these changes following SFEP administration were accidental and not dose-dependent. Additionally, no correlation was found between gender and other parameters. Conclusions : Therefore, the NOAEL of SFEP was confirmed to be 250 mg/kg.

• 생약학회지
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• 제27권3호
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• pp.184-189
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• 1996

Ohyaksungisan, combined preparation of crude drugs, has been used for hemiplegia, arthralgia and paralysis in traditional Korean medicine. The anti-inflammatory activity of the aqueous extract from Ohyaksungisan(OSSE) was investigated on acetic acid-induced edema and adjuvant arthritis in rats. Acute toxicity and analgesic action in mice were also examined. Its anti-inflammatory activity on 5% acetic acid-induced edema and adjuvant arthritis was observed with oral administration. The acute toxicity showed 10% mortality at 2400 mg/kg (p.o), but was not showed at 1200 mg/kg (i.p). OSSE was showed to have significant analgesic action (P<0.05) at 150 mg/kg and this action was strengthened at 300, 600 mg/kg. The anti-inflammatory effect was showed significant preventive effect on the hind paw edema from 90 min. and the adjuvant arthritis, when orally administered for 19 days. showed significant inhibitory effect on the hind paw edema from the 5th day.

• 농약과학회지
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• 제15권2호
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• pp.208-217
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• 2011

피리미설판에 대한 독성을 평가하고 일일섭취허용량을 설정하기 위하여 다양한 인축독성 시험성적서를 검토하였다. 대사시험결과, 주로 대변을 통해 배설되었으며, 급성독성은 낮았고, 피부, 안점막자극성과 피부감작성은 없었다. 랫드 90일 반복투여 경구독성시험결과에서 피리미설판 투여에 따른 영향은 혈액학적지표 및 간장에서 확인되었고 발암성은 없었으며, 번식독성, 기형독성 등에서 번식능력 몇 기형에 대한 영향 및 유전독성은 확인되지 않았다. 최대무작용량은 개 90일 반복투여 경구독성시험 10 mg/kg/day였으며, 안전계수 100으로 나눈 0.1 mg/kg/day을 일일섭취허용량(ADI)으로 설정하였다.