• The Journal of Korean Medicine
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• v.44 no.3
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• pp.29-38
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• 2023

Objectives: This study aimed to investigate the acute oral toxicity of 77 herbal formulas and performed in male and female Sprague-Dawley (SD) rats as per the guidelines mentioned in Ministry of Food and Drug Safety. Methods: Each sex of SD rat were administered a single dose (2000 or 5000 mg/kg) of 77 herbal formulas via oral gavage; the control group received vehicle only. After administration, the mortality, clinical signs, gross findings, and body weight were followed up for 15 days. Results: After administration of 77 herbal formulas, mortality, clinical signs, body weight changes, and gross findings related to the test substances were not observed in both male and female groups. Conclusion: Our results demonstrate the single-dose oral administration of 77 herbal formulas produced no mortality indicating the approximate lethal dose is greater than 2000 or 5000 mg/kg body weight.

• Journal of Nutrition and Health
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• v.27 no.9
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• pp.940-948
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• 1994

The present study was designed to determine if prenatal and postnatal Se nutriture affects Se concentration, glutathione peroxidase(GSHPx) activity and phospholipid distribution of the neonatal rat lung. Female SD rats were bred and fed a semipurified Se-deficient(0.04ppm, Se-) or a Se-adequate(0.5ppm, Se+) diet through pregnancy and lactation. On d 2 of lactation, maternal dietary Se had no significant effect on pulmonary Se concentration of pups. On d 16 of lactation, mean milk Se concentration in Se- dams was significantly lower than that in Se+ dams. Milk Se concentration was reflected on lung Se concentration and GSHPx activity of d 16 pups, which were dramatically decreased in Se- pups. In addition, pulmonary disaturated phosphatidyl choline/total phosphatidyl choline ratio was also significantly decreased in Se- pups, implying impaired function of pulmonary surfactant. These data indicate that adequate Se nutrition is important in the maturation of neonatal rat lungs.

• Korean Journal of Animal Reproduction
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• v.10 no.2
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• pp.168-174
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• 1986

These experiments were carried out to clarify the optimalconditions and interspecific cross reaction of H-Y antibody activity. H-Y antiserum was prepared in inbred SD female rats and Balb/c female mice by repeated immunization of rat newborn testis homogemate, rat and mouse spleen cells obtained from males of same strain. The activity of H-Y antibody in antiserum was tested by ELISA and biological tests. The cross reactivity of H-Y antibody was confirmed by culturing mouse and rabbit embryos in medium containing H-Y antibody and complement obtained from rat and guinea pig, respectively. The optimal condition for the activity of H-Y antibody was also investigated by culturing embryos in medium with different pH and complement concentration. The results obtained in these experiments were summarized as follows: 1. The formation rates of H-Y antibody in rats immunized with newborn testis and spleen cell were 40.0 and 50.0% respectively, and that in mouse immunized with spleen cell was 48.4%. 2. The activity of H-Y antibody was not affected by pH in range of 6.5 to 8.0, and the same was true for the relative concentration of complement to the H-Y antibody. 3. Minimum time needed for the activity of H-Y antibody was confirmed to be 0.5 to 1 hour and 24 to 48 hours respectively for the zona free embryos and intact embryos. 4. When mouse and rabbit embryos were treated with H-Y antibody obtained from rat, 46.4 and 54.8% of embryos were retarded or destroyed. From these results it could be said that H-Y antibody had strong interspecific cross reactivity.

• Journal of Pharmacopuncture
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• v.18 no.4
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• pp.38-44
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• 2015

Objectives: Radix Ginseng has been used for thousands of years to treat a wide variety of diseases. Radix ginseng has also been used as a traditional medicine for boosting Qi energy and tonifying the spleen and lungs. Traditionally, its effect could be obtained orally. Nowadays, a new method, the injection of herbal medicine, is being used. This study was performed to investigate the single-dose intravenous toxicity of water-soluble ginseng pharmacopuncture (WSGP) in Sprague-Dawley (SD) rats. Methods: All experiments were carried out at Biotoxtech, an institute authorized to perform non-clinical studies under the regulation of Good Laboratory Practice (GLP). At the age of six weeks, 40 SD rats, 20 male rats and 20 female rats, were allocated into one of 4 groups according to the dosages they would receive. The WSGP was prepared in the Korean Pharmacopuncture Institute under the regulation of Korea-Good Manufacturing Practice (K-GMP). Dosages of WSGP were 0.1, 0.5 and 1.0 mL/animal for the experimental groups, and normal saline was administered to the control group. The rat's general conditions and body weights, the results of their hematological and biochemistry tests, and their necropsy and histopathological findings were investigated to identify the toxicological effect of WSGP injected intravenously. The effect was examined for 14 days after the WSGP injection. This study was performed under the approval of the Institutional Animal Ethics Committee of Biotoxtech. Results: No deaths were found in this single-dose toxicity test on the intravenous injection of WSGP, and no significant changes in the rat's general conditions and body weights, the results on their hematological and biochemistry test, and their necropsy findings were observed during the test. The local area of the injection site showed minial change. The lethal dose was assumed to be over 1.0 mL/animal in both sexes. Conclusion: These results indicate that WSGP is safe at dosages up to 1 mL/animal.

• Journal of Food Hygiene and Safety
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• v.23 no.4
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• pp.297-303
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• 2008

Naringin, major citrus flavonoids, has been identified to exert antioxidative, antidiabetic, and lipid lowering effects. In this study, we examined the effect of 0.2 g/kg, 0.5 g/kg naringin supplementation for 3 times/week for 5 weeks on lipid metabolism and antithrombotic capacity in rat. Eighteen five week-old Sprague Dawley(SD) female rats, which had initial body weights of $246{\pm}9g$, were randomly divided into three groups: Control (non naringin group); Low (0.2 g/kg naringin-supplemented group); High (0.5 g/kg naringin-supplemented group). Three groups of rats were supplemented with three experimental diets for 5 weeks and we investigated antithrombotic capacity before sacrifice. Naringin did not significantly alter the body weight gain, relative organ weight. However, the level of serum triglyceride, serum free fatty acid, serum total lipid and serum glucose levels were significantly lowered compared to those of control. The high group (0.5 g/kg naringin-supplemented group) was showed significantly increased bleeding time compared to control group. These results suggest that naringin supplemental diets reduces the level of hypertension, glycosuria and fatness on the female SD rats, when orally administered below the dosage 0.5 g/kg for 5 weeks.

• Journal of Korean Medicine Rehabilitation
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• v.25 no.3
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• pp.1-9
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• 2015

Objectives To evaluate Shinbaro Pharmacopuncture safety through analysis of potential single-dose intramuscular toxicity of Sinbaro Pharmacopucture in SD rats and Beagle dogs. Methods Single-dose intramuscular toxicity of Shinbaro Pharmacopuncture was assessed in accordance with Korea Food and Drug Administration Guidelines for toxicity testing of Medicinal Products. The SD rats were treated intramuscularly with Shinbaro Pharmacopuncture at doses of 0, 4.6, 9.2, and 18.5 mg/kg, respectively. The Beagle dogs were treated intramuscularly with Shinbaro Pharmacopuncture at doses of 2.3, and 4.6 mg/kg, respectively, and after 3 days, the procedure was repeated a second time at doses of 0.6, and 1.2 mg/kg, respectively, for toxicity testing. Mortality, change in body weight, and necropsy findings were examined for the study period. Results There were no mortalities, general symptoms, or body weight changes in the SD rats. While pyelectasis of the left kidney was observed in a male rat in the 4.6 mg/kg administration group, natural occurrence is common, and does not appear to be related with the test substance. No mortalities were observed in the Beagle dogs. In assessment of general symptoms, a female dog in the 9.2 mg/kg group displayed body weight decrease due to leftover food, but the change in body weight was within the normal range seen at 6~7 months, and the necropsy findings were not significant. The toxicity of the test substance appears to be minimal. Conclusions The results suggest that the lethal dose 50 ($LD_{50}$) and approximate lethaldose (ALD) value in single intramuscular administration of Shinbaro Pharmacopuncture in SD rats and Beagle dogs are higher than 18.5 mg/kg.

• Korean Journal of Animal Reproduction
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• v.20 no.3
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• pp.271-278
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• 1996

The present study was carried out to sex effectively mouse and rabbit embryos using rat H-Y antiserum and to improve the rate of rat producing H-Y antiserum with H-Y antibody. The H-Y antiserum was prepared from inbred SD strain female rat immunized by intrasplenic injection and subsequent intraperitioneal booster of testis cell of syngenic male newborn rat. the titer of antiserum was identified by in vitro cytotoxicity test of mouse embryos. The rabbit embryos exposed to the H-Y antiserum was classified to the developed (H-Y negative) or delayed (H-Y positive) group. The H-Y negative rabbit embryos were transferred to recipients and sex of offspring was examined. 1. When mouse embryos were exposed to the rat H-Y antisera, the ratio of embryos developed vs delayed was various. The H-Y antisera where the ratio of embryos developed vs delayed showed the range of 40~60% were recognized as having titer of H-Y antibody. 2. When the subsequent intraperitioneal boosters were followed after priming of intrasplenic injection of H-Y antigen, the rate of rat producting the H-Y antiserum with H-U antibody was 13, 27, 70 and 73% in control, 1st B, 2nd B and 3rd B, respectively. The rate in 2nd B and 3rd B was significantly(P<0.05) higher than that in control and 1st B. 3. When the rabbit morulae were exposed to the rat H-Y antiserum with H-Y antibody, the ratio of morulae developed versus delayed was 42:58% and it was close to the natural sex ratio 50:50%. It was confirmed that the rat H-Y antiserum was cross reactive to the rabbit morulae. 4. When the H-Y negative rabbit embryos were transferred to the recipients, the pregnancy rate was 50% and 83% of the newborns were females. In conclusion, the rat H-Y antiserum with high titer of H-Y antibody was able to be obtained from the female rat immunized by the intrasplenic injection followed by the second intrapent oneal booster of testis cells at a week interval. When the rabbit embryos negative to the rat H-Y antiserum were transferred, 83% of the newborns were females.

• Asian-Australasian Journal of Animal Sciences
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• v.32 no.8
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• pp.1145-1152
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• 2019

Objective: Mulberry (Morus alba L.) is a cultivated shrub grown widely in the sub-tropical and tropical areas. It has been shown that mulberry leaf contains high levels of protein while having polyphenols as phytonutrients. Therefore, it is important to conduct an experiment to assess potential toxic level from mulberry on behavior, blood hematological and coagulation parameter using Sprague-Dawley (SD) rats. Methods: Both male and female SD rats were given an intragastric administration of respective treatments of mulberry leaf intakes (control, low and high levels). Parameters of feed intake, hematological and coagulation of blood parameters, as well as liveweight changes were taken during the 7 d of adaptation, 28 d of treatment exposure, and 14 d of recovery periods, respectively. All treatment data were statistically analyzed using analysis of variance of SPSS17.0 for Windows Statistical Software following the Randomized complete block design with sex as a block. Results: Most of the parameters of the physical symptoms of the SD rats, were not significantly different (p>0.05) when compared with that of the control group. Those which remain unchanged in each dose group were, body weight (BW) gain, feed intake, the hematology and coagulation indexes. Although, there were a few individual indicators that were abnormal, but the overall physiological appearance of the rats were normal. Conclusion: Results under this experiment revealed that most hematological and coagulation parameters of the SD rats in both male and female were normal, although the weight gain of female rats in high-dose group was significantly reduced than those of the male rats. Under this study, the use of mulberry leaf up to 2 g/kg BW did not result in abnormal phenomenon in the SD rats. These findings would offer useful information for further in vivo feeding trials in animals to extensively use of mulberry leaf to improve animal production, particularly in P.R. China.

• 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.

• Journal of Society of Preventive Korean Medicine
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• v.17 no.2
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• pp.157-168
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• 2013

The objective of this study was to characterize the adverse effects of Ahnjon-Yichun-Tang during early pregnancy. Following successful mating, female Sprague-Dawley rats were given Ahnjon-Yichun-Tang(AYT) extract by oral administration daily with dose of 150mg (n=10), 300mg(n=10), 450mg(n=10) for 20 days of pregnancy. The rats in Control group(n=10) were orally administrated with Saline. All pregnant rats of Ahnjon-Yichun-Tang-treated and Control groups were sacrificed on day 20 of pregnancy. The pregnancy outcome was determined and the internal and reproductive organs of pregnant rat were observed. The fetuses were examined for the presence of various developmental toxic endpoints and stained with alcian blue and alizarin red S, and observed skeletal malformations. The results obtained in this study represent that there is no significant changes between Control and Ahnjon-Yichun-Tang-treated groups in body weight, organ weight, blood chemistry values, hematological values and pregnancy indexes of pregnant rat. The skeletal malformation of fetus was not observed as well. These results suggest that oral administration of Ahnjon-Yichun-Tang does not produce either maternal or developmental toxicity.