• 대한본초학회지
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• 제34권3호
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• pp.31-36
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• 2019

Objectives : In this animal study, we performed the single oral dose toxicity test of Standardized Cornus officinalis Sieb. et Zucc. and Psoralea corylifolia L. 30% ethanol extract (SCP) in Sprague-Dawley (SD) rats owing to aims for verifying approximate lethal dose (ALD). Methods : According to OECD guidelines for the testing of chemicals section 4 health effects test No. 420 acute oral toxicity study - fixed dose procedure (17 December 2001), single oral dose toxicity test was performed. Animals were divided into two groups: Group 1, vehicle-treated rats (Control); Group 2, SCP 5000 mg/kg treated rats. SCP is composed of two medicinal herbs: Cornus officinalis Sieb. et Zucc. (650 g) and Psoralea corylifolia L. (350 g) in 30% ethanol. SCP was once orally administered to female and male SD rats at dose levels of 5000 mg/kg. Animals were monitored on the mortality, clinical signs, body weight changes and necropsy findings for 14 days. Results : After single oral treatment of SCP, we could not find any mortality up to 5000 mg/kg. Compared with the control group, there were also no significant differences in clinical sign, weight change, weight gain and gross abnormalities in SCP 5000 mg/kg-treated group. Conclusions : Taken together, these results suggest that the ALD of SCP in both female and male SD rats were considered as over 5000 mg/kg. Results from this study provide scientific evidence for the safety of SCP.

• 대한약학회:학술대회논문집
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• 대한약학회 2002년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2
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• pp.296.2-296.2
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• 2002

Our previous study demonstrated that 2.3', 4.4'. 5- Pentachlorobiphenyl (PCB 118) showed an antiestrogenic activity in vitro and in vivo. In the present study. we examined the effect of PCB 118 on postnatal reproductive development in female rats. PCB 118 (0.001. 0.01 or 0.1 mg/kg/day) was administered to pregnant female SD rats from gestation day (GO) 6 to 18 via subcutaneous injection. and developmental parameters such as vaginal opening were determined. PCB 118 significantly delayed vaginal opening of female offsprings at dose of 0.1 ${\mu}g$/kg/day. whereas had no effects on body weights. In addition. in utero treatment of PCB 118 caused significant decreases in serum levels of E2, T3 and T4 in female oftsprings at certain doses on postnatal day (PND) 22. Our data of results indicate that in utero exposure to PCB 118 may postnatal reproductive development in female rat through its antiestrogenic activity.

• Toxicological Research
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• 제18권1호
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• pp.47-57
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• 2002

The subacute oral toxicity of 1-(4-methylpiperazinyl)-3-phenylisoquinoline (CWJ- a-5) was investigated in Sprague-Dawley (SD) rats. Five groups of 5 males and 5 females were orally administered at doses of 0, 37.5, 75, 150 and 200 mg/kg with CWJ-a-5 for 2 weeks. In clinical signs, Salivation was observed in the 75, 150 and 500 mg/kg male and female groups. Loss of fur was observed in the 500 mg/kg male and female group. Body weight were significantly decreased in the 150 and 500 mg/kg male groups and in the 500 mg/kg female group. Food consumption was significantly decreased in the 300 mg/kg male group. In serum biochemistry, total cholesterol and phospholipid were significantly increased in 500 mg/kg male and female group. Aspartate aminotransferase was significantly increased in the 500 mg/kg female group. In histopathological examination, vacuolar degeneration of renal tubules in the kidney, vacuolar degeneration of hepatocytes in the liver vacuolar degeneration of myocytes in the heart, vacuolar degeneration of histiocytes in the spleen and thymus, atrophy of seminiferous tubule and degeneration of germinal epithelium in the testis, vacuolar degeneration of corpus luteum, granulosa cell and theca cell in the ovary were observed in the 150 and 500 mg/kg male and female groups. Based on these results, the no observed adverse effect level (NOAEL) with CWJ-a-5 was considered to be 75 mg/kg and the absolute toxic dose was considered to be 150 mg/kg in this study

• 대한한의학방제학회지
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• 제16권1호
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• pp.147-168
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• 2008

HYTE (Hyeonggaeyeongyotang Extract), a polyherbal formula has been used as folk medicine, 28days repeat oral dose toxicity was tested in SD rats according to KFDA Guideline[2005-60]. Methods : In this study, mortality, clinical signs, body weight and gains, food and water consumption, ophthalmologic observation, urinalysis, hematology, serum biochemistry, gross findings, organ weight and histopathological observations were conducted during 28days of dosing periods. Results: 1. No HYTE treatment-related mortalities and clinical signs were detected in all dosing levels tested in male and female rats during the whole experimental periods. 2. No HYTE treatment-related changes on body weight, gains and food consumption were detected in all dosing levels tested in male and female rats during the whole experimental periods except for 2000mg/kg-dosing female groups in which significantly increase of body weight, gains, food and water consumption were detected compared to that of vehicle control in some points. 3. No HYTE treatment-related changes on ophthalmologic examination were detected in all dosing levels tested in male and female rats. 4. No HYTE treatment-related changes on urinalysis were detected in all dosing levels tested in male and female rats except for 2000mg/kg-dosing female groups in which, significantly increase of urine volume and related decrease on the urine specific gravity were detected as secondary effects of increase on the water consumptions not HYTE treatment-related toxicological signs. 5. No HYTE treatment-related changes on hematology were detected in all dosing levels tested in male and female rats except for increases in the total WBC count and lymphocytes of 2000mg/kg-dosing male and female groups with decrease of large unstained cells as pharmacological effects of immune enhancements not HYTE treatment-related toxicological signs. 6. No HYTE treatment-related changes on serum biochemistry were detected in all dosing levels tested in male and female rats. 7. No HYTE treatment-related changes on gross findings, organ weight and histopathology were detected in all dosing levels tested in male and female rats except for 2000mg/kg-dosing male and female groups in which, spleen and thymus organ weights, hypertrophy at gross observation and hyperpalsia of lymphoid cells and follicles at histopathological observation in spleen and thymus were detected as pharmacological effects of immune enhancements not HYTE treatment-related toxicological signs. Conclusions : Based on these results, the NOAEL and MTD of HYTE in SD rats were considered as over 2000mg/kg, respectively at 28days repeat oral dose toxicity test because most of these findings were considered as results of pharmacological effects of immune enhancements not HYTE treatment-related toxicological signs or secondary effects.

• 대한약침학회지
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• 제18권3호
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• pp.42-48
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• 2015

Objectives: The aim of the study is to investigate both the single-dose intramuscular injection toxicity and the approximate lethal dose of water-soluble Carthami-flos and Cervi cornu parvum pharmacopuncture (WCFC) in male and female Sprague-Dawley (SD) rats. Methods: The study was conducted at Biotoxtech Co. according to the Good Laboratory Practice (GLP) regulation and the toxicity test guidelines of the Ministry of Food and Drug Safety (MFDS) after approval of the Institutional Animal Care and Use Committee. Dosages for the control, high dose, middle dose and low dose groups were 0.5 mL/animal of saline and 0.5, 0.25 and 0.125 mL/animal of WCFC, respectively. WCFC was injected into the muscle of the left femoral region by using a disposable syringe (1 mL, 26 gauge). The general symptoms and mortality were observed 30 minutes, 1, 2, 4, and 6 hours after the first injection and then daily for 14 days after the injection. The body weights of the SD rats were measured on the day of the injection (before injection) and on the third, seventh, and fourteenth days after the injection. Serum biochemical and hematologic tests, necropsy examinations, and histopathologic examinations at the injection site were performed after the observation period. Results: No deaths, abnormal clinical symptoms, or significant weight changes were observed in either male or female SD rats in the control or the test (0.125, 0.25, and 0.5 mL/animal) groups during the observation period. No significant differences in hematology and serum biochemistry and no macroscopic abnormalities at necropsy were found. No abnormal reactions at injection sites were noted on the topical tolerance tests. Conclusion: The results of this single-dose toxicity study show that WCFC is safe, its lethal doses in male and female SD rats being estimated to be higher than 0.5 mL/animal.

• 대한약학회:학술대회논문집
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• 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.1
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• pp.155.1-155.1
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• 2003

In the present study, the effect of DW-1350, a newly synthesized anti-osteoporotic agent, was evaluated in ovariectomized Rat. Female SD Rat mice underwent bilateral ovariectomy for prevention study that test article was administered from 2 days after ovariectomy for 6 weeks, for therapeutic study it was conducted from 6 weeks after ovariectomy for three months. (omitted)

• 한국산업보건학회지
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• 제17권3호
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• pp.181-191
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• 2007

With the 2-Butanethiol, which is an unidentified inhalation toxic material, acute inhalation toxicity was tested with SD rats. The $LC_{50}$ was evaluated to be 2,500 ppm (9.22 mg/L) or higher which falls under the criteria of acute toxicity Category 3 (500<$LC_{50}$<2,500 ppm) in the Industrial Safety and Health Act. In the subchronical inhalation toxicity test by 0, 25, 100, and 400 ppm, 6 hours a day, 5 days a week, for 13 weeks repeated exposure, though no death or particular clinical presentation was observed, in the female 25 and 400 ppm group, including weight change, and in each concentration group including 400 ppm, change of feed rate, eye stimulation, motility change in male group, and lesions in blood and blood biochemical were observed. In the internal organs weight, 25, 100, and 400 ppm groups in male and 400 ppm group in female showed significant (p<0.05) changes in kidney, liver, thymus, and lung. In the pathological tissue test, severe cortical tubular hyaline droplets were observed in the male 400 ppm group, and all male rats of 400 ppm group and 2 female individuals showed tubular degeneration/regeneration accompanied with pigmentation, showing that the target organs of inhalation exposure of 2-Butanethiol are spleen, kidney, nasal cavity, and adrenal. Through the tests, the NOEL of 2-Butanethiol was evaluated to be 25 ppm (0.092 mg/L) or less for both male and female.

• 한국식품과학회지
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• 제52권5호
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• pp.555-559
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• 2020

본 연구에서는 팔라티노스 시럽 Pal-L을 반복 투여하였을 때 나타나는 독성을 확인하기 위하여 암수 SD rat에 1,000 mg/kg의 용량으로 14일간 1일 1회 경구 투여한 후 사망률, 일반 증상, 체중 및 사료/음수 섭취량 변화, 장기 중량의 변화, 혈액 및 혈액 생화학적 변화, 뇨 분석 및 간과 신장의 조직학적 검사에 대한 변화를 관찰하였다. 실험 결과 투여 기간 중 암수 대조군 및 Pal-L을 투여한 군 모두 사망 동물은 발견되지 않았으며, 팔라티노스의 반복 투여에 의한 일반 증상의 변화 역시 관찰되지 않았다. 또한 체중 및 사료/음수 섭취량에 대한 변화, 장기 중량의 변화에 대한 이상 변화 역시 관찰되지 않았다. 부검 후 채취한 전혈의 혈액학적 분석 결과, 암컷 Pal-L 투여군에서 Hgb, MCHC, PLT의 수치가 유의적인 차이를 보였으나 정상 범위 내에서의 차이로 팔라티노스에 의한 독성이라고 판단하기는 어려웠으며, 혈액의 생화학적 분석 결과 암수 대조군 및 시험군에서 모든 항목이 정상 수치를 나타냈다. 부검 전 채취한 뇨를 분석한 결과 암컷 시험군에서 glucose, 수컷 시험군에서 total protein 수치가 유의적으로 감소하였지만 정상 범위 내에서의 차이로 팔라티노스에 의한 독성이라고 판단하기 또한 어려웠다. 혈액, 혈청 및 뇨에서 일부 유의적인 차이가 나타난 것을 바탕으로 간 및 신장에 대한 조직병리학적 검사를 진행한 결과 대조군과 시험군 모두 조직학적 이상은 관찰되지 않았다. 이상의 결과를 종합해보면 SD rat을 이용하여 팔라티노스(Palatinose-L)를 1,000 mg/kg/day의 용량으로 14일간 반복 경구투여하고 사망 여부, 체중 변화, 혈액학적 검사, 혈액 생화학적 검사, 뇨 분석 및 조직학적 검사 등을 통해 독성 평가를 진행하고자 하였다. 그 결과 2주간의 투여 기간 동안 시험 동물에게 어떠한 독성도 관찰되지 않았음을 확인하였고, 이에 따라 팔라티노스(Pal-L)는 1,000 mg/kg/day 용량까지는 독성이 없는 안전한 물질이라는 것이 최종 확인되었다.

• Journal of Acupuncture Research
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• 제32권4호
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• pp.77-89
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• 2015

Objectives : To evaluate the safety of multiple-dose intramuscular Shinbaro Pharmacopuncture in male and female Sprague-Dawley(SD) rats over a period of 4 weeks(12 sessions). Methods : In order to test the safety of multiple-dose intramuscular Shinbaro Pharmacopuncture we used 40 healthy male and female 6-week old SD rats(male weight 171.79~196.37 g, female weight 127.93~146.43 g). Shinbaro Pharmacopuncture was administered intramuscularly to male and female SD rats at doses of 4.6 (low dose group, n=10), 9.2 (moderate dose group, n=10), and 18.5 mg/kg(high dose group, n=10), respectively. General symptoms, body weight changes, blood tests, biochemical testing, necropsy, organ weight and histopathogical findings were examined over a 4-week period. Results : 1. No mortalities or adverse effects were caused by the investigational substance were observed during the study period. 2. There was no significant difference in body weight caused by the the investigational substance across all groups. 3. No significant between-group difference was found to be caused by the investigational substance in blood tests and biochemical testing. 4. No abnormalities were detected by a necropsy examination with the unaided eye at the macro level after treatment with the investigational substance. 5. Difference in organ weight between groups caused by the investigational substance was not found. 6. All groups did not exhibit pathological findings caused by the investigational substance in histopathogical examination. Conclusions : According to these results, Shinbaro Pharmacopuncture has no systemic or organ toxicity with multiple-dose intramuscular administrations in male and female SD rats over a 4-week period (12 sessions). These results imply that no adverse effects are observed at a level (NOAEL) of Shinbaro Pharmacopuncture of 18.5 mg/kg.

• 대한한방부인과학회지
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• 제26권4호
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• pp.1-13
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• 2013

Objectives: In this study, it was carried out to evaluate the acute oral toxicity of Root of Polygala teunifolia Willd. in Sprague-Dawley (SD) rats. Methods: Male and female rats were administered orally with Root of Polygala teunifolia Willd. water extract of 1,000 mg/kg (low dosage group), 2,000 mg/kg (middle dosage group) and 4,000 mg/kg (high dosage group). We daily observed number of deaths, clinical signs and gross findings for 7 days. After 7 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. But we found out histopathological changes in liver fat tissues of female. In addition, there were no significant changes of gross body and individual organs weight. Conclusions: These results suggest that water soluble extract of Root of Polygala teunifolia Willd. has not acute oral toxicity and oral $LD_{50}$ value was over 4,000 mg/kg in SD rats.