• Biomolecules & Therapeutics
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• v.10 no.2
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• pp.114-116
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• 2002

This study was performed to investigate the acute toxicity of PEG-hemoglobin SB1, a blood substitute, in beagle dogs. The male and female dogs were administered intravenously at the doses of 0.4375, 0.875 and 1.75 g/kg body weight, respectively. After a single intravenous administration of SB1 to dogs, we observed them daily for 2 weeks. SB1 did not induce any toxic signs in the mortalities, clinical signs, body weight changes, and gross necropsy findings of dogs. Based on these results, acute toxicity, dogs SB1 may have no side effect and its $LD_{50}$ value may be over 1.75 g/kg (25 ml/kg) of body weight in dogs.

• Journal of Life Science
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• v.11 no.2
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• pp.97-102
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• 2001

This study was performed to evaluate the actue sbucutaneous toxicity of hydroxyapatite sinter produced from tuna bone in Sprague-Dawley(SD) rats. Hydroxyapatite sinter was administrated at dose levels of 5000, 2500, 1250, 625, 312.5 and 0 mg/kg. After single subcutaneous adiminstration to both sexes to both sexes SD rats, we observed rats for 14 days. Hydroxyapatite sinter did not induce any toxic signs inmortalities, clinical findings, body weights and gross findings of the rats. In view of result, it was impossible to estimate LD/ sub 50/ values in SD rats. In conclusion, these results suggest that hydroxyapatite sinter produced from tuna bone has no effect on acute subcutaneous toxicity in SD rats.

• Journal of Society of Preventive Korean Medicine
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• v.10 no.1
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• pp.123-140
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• 2006

This experiment was carried out to study on the safety assessment of Pinus densiflora Siebold et Zuccarini for Hebal-acupuncture. SD rats and ICR mice were used for acute toxicity test, the results were summerized as follows; 1. In rats and mice, $LD_{50}$ value could not be measured. 2. There were no abnormal finding in acute toxicity test treated Pinus densiflora Siebold et Zuccarini for Hebal-acupuncture.

• Toxicological Research
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• v.12 no.2
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• pp.323-330
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• 1996

Subacute toxicity study was performed in Sprague-Dawley rats after daily oral administration of KDRD-002 0.23, 0.7, 2.1 g/kg for one month. There were no clinical signs and pathological changes compared with control group but slight decrease in spontaneous motor activities and locomotions at high dose group of KDRD-002. Body weights were not significantly changed between control and KDRD-002 treated groups. In histopathological examinations, however, two animals (1 male, 1 female) showed abnormal increases in the weights of spleen tissues at middle dose group of KDRD-002. Also, there were some hemorrhages in lung tissues at low dose group of KDRD-002, but it was not considered to be caused by KDRD-002. These results suggest that KDRD-002 does not induce any significant subacute oral toxicity in Sprague-Dawley rats.

• Natural Product Sciences
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• v.14 no.2
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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.

• Toxicological Research
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• v.17 no.3
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• pp.195-201
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• 2001

The OECD acute toxicity guideline has been revised recently to protect animal welfare. The GLP authority of the Ministry of Environment, the National Institute for Environmental Research, recommended GLP laboratories in Korea to ufo the revised acute toxicity guideline. This study was carried out to optimize newly adopted OECD test guideline 420 (TG 420). Bisphenol A was selected for test chemical. Following TG420, Bisphenol A was classified as class 5/unclassified group. The revised TG 420 was very effective test in minimizing animal number and classifying chemicals. The method, however had short-coming in evaluation of test results statistically because the test had no control group, and the test should be stopped when animals were dead at the lowest dose or alive at the highest dose. TG 420 required at Least 20 animals to complete the test, but it could result in producing unused animals that need to sacrifice.

• Journal of Pharmacopuncture
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• v.18 no.2
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• pp.51-59
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• 2015

Objectives: This study was performed to analyze the toxicity and to find the lethal dose of the test substance Hominis placenta pharmacopuncture when used as a single-dose in 6 week old, male and female Sprague-Dawley (SD) rats. Methods: All experiments were conducted at Biotoxtech (Chungwon, Korea), an institution authorized to perform non clinical studies, under the regulations of Good Laboratory Practice (GLP). SD rats were chosen for the pilot study. Doses of Hominis placenta pharmacopuncture extracts, 0.125, 0.25 and 0.5 mL, were administered to the experimental group, and 0.5 mL doses of normal saline solution were administered to the control group. This study was conducted under the approval of the Institutional Animal Ethics Committee. Results: No deaths or abnormalities occurred in any of the groups. Also, no significant changes in body weights were observed among the groups, and no significant differences in hematology/biochemistry, necropsy, and histopathology results were noted. Hematologically, some changes in the male rats in two experimental groups were observed, but those changes had no clinical or toxicological meaning because they were not dose dependent. Histopathological tests on the injected parts showed cell infiltration in the male rats in one of the experimental groups; however, that result was due to spontaneous generation and had no toxicological meaning. Therefore, this study showed that Hominis placenta pharmacopuncture had no effect on the injected parts in terms of clinical signs, body weight, hematology, clinical chemistry, and necropsy. Conclusion: As a result of single-dose tests of the test substance Hominis placenta pharmacopuncture in 4 groups of rats, the lethal dose for both males and females exceeded 0.5 mL/animal. Therefore, the above findings suggest that treatment with Hominis placenta pharmacopuncture is relatively safe. Further studies on this subject are needed.

• Journal of Pharmacopuncture
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• v.19 no.3
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• pp.231-238
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• 2016

Objectives: This study used repeated intravenous injections of Saeng Maek San (SMS) injection in Sprague-Dawley (SD) rats to assess the toxicity and the stability of SMS. Methods: Six-week-old male and female SD rats reared by Orient bio Inc were chosen for this pilot study. They were randomly split into four groups: Group 1 (G1), the control group (0.3 mL of normal saline solution/day/animal), and Groups 2, 3 and 4 (G2, G3 and G4), the experimental groups (0.1, 0.2 and 0.3 mL/day/animal of SMS), respectively. Each animal received an intravenous injection of SMS once a day for four weeks. Clinical signs, body weight changes, and food consumption were monitored during the observation period, and urinalysis and hematology were conducted after four weeks of SMS or saline administration. Results: No deaths occurred in any of the four groups during the observation period. Compared to the control group, male and female rats in groups 3 and 4 (0.2 and 0.3 mL/animal/day) showed hemoglobinuria, but the low-dosage group (G2, 0.1 mL/animal/day) showed no significant changes in the clinical signs test. No significant changes due to SMS were observed in the experimental groups regarding body weight changes, food consumption urinalysis, or hematology. Conclusion: During this study, no mortalities were observed in any of the experimental groups and no hemoglobinuria was observed in the low dosage group (0.1 mL/animal/day) while it was intermittently observed in groups 3 and 4 (0.2 and 0.3 mL/animal/day). Thus, we suggest that the no-observed adverse-effect level (NOAEL) is 0.1 mL/animal/day in male and female SD rats.

• Toxicological Research
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• v.32 no.2
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• pp.159-173
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• 2016

Crickets have been attracting considerable interest in the field of nutrition and toxicology due to the global exhaustion of food resulting from a growing population. The cricket is normally eaten in several countries after roasting, similar to the grasshopper; however, safety evaluation data on cricket powder is limited. Here, we performed general toxicity studies of cricket powder including a single, 2-week repeated dose range evaluation test, a 13-week repeated oral dose toxicity test in Sprague-Dawley rats, a single oral dose toxicity test in Beagle dogs, and a skin sensitization test in guinea pigs following the Organization for Economic Cooperation and Development test guidelines 406 and 408 in addition to Good Laboratory Practice. To investigate the NOAEL and target organs of cricket powder, Sprague-Dawley rats were allocated to 4 groups: vehicle control, 1,250 mg/kg, 2,500 mg/kg, 5,000 mg/kg dose test groups and cricket powder was administered over 13 weeks after single dose and dose range finding studies in rats based on the results of the single oral administration toxicity study in rats and Beagle dogs. The results of the study showed that the NOAEL of cricket powder was over 5,000 mg/kg for both sexes of rats without adverse effects in a 13-week repeated oral toxicity study and there was no skin hypersensitivity reaction. Therefore, our results reveal that crickets can be widely used as a new substitute food or nutrient resource.

• Archives of Pharmacal Research
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• v.21 no.4
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• pp.391-397
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• 1998

The toxicity evaluation of oriental herbal drugs is of great concern at present. Bojungchisup-tang (BCST, in Korean), a decocted medicine of oriental herbal mixture, is now well used in clinic at oriental hospitals for the treatment of edema of several diseases in practice. However, the toxicity of the oriental herbal decocted medicines such as genetic toxicity is not well defined until now. In this respect, to clarify the genetic toxicity of BCST, in vitro chromosome aberration assay with Chinese hamster lung (CHL) fibroblasts and in vivo supravital micronucleus assay with mouse peripheral reticulocytes were performed in this study. In the chromosome aberration assay, we used 5,000 $\mu\textrm{g}$/ml BCST as maximum concentration because no remarkable cytotoxicity in CHL cells was observed both in the presence and absence of S-9 metabolic activation system. No statistical significant differences of chromosome aberrations were observed in CHL cells treated with 5,000, 2,500 and 1,250 $\mu\textrm{g}$/ml BCST for 6 hour both in the presence and absence of S-9 metabolic activation. However, very weak positive result (6.5-8.0% aberration) of BCST was obtained in the absence of S-9 metabolic activation system at 5,000 $\mu\textrm{g}$/ml BCST when treated for 24 hour, i.e. 1.5 normal cell cycle time. And also, in vivo clastogenicity of BCST was studied by acridine orange-supravital staining micronucleus assay using mouse peripheral reticulocytes. We used 2,000 mg/kg as the highest oral dose in this micronucleus assay because no acute oral toxicity of BCST was observed in mice. The optimum induction time of micronucleated reticulocytes (MNRETS) was determined as 36 hours after oral administration of 2,000 mg/kg BCST. No significant differences of MNRETs between control and BCST treatment groups were observed in vivo micronucieus assay. From these results, BCST revealed very weak positive result in chromosome aberration assay in vitro with CHL cells and no clastogenicity in micronucieus assay in vivo.