• Journal of Oriental Neuropsychiatry
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• v.23 no.2
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• pp.121-128
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• 2012

Objectives : This research investigates the single oral dose toxicity of ACM in SD rats. Methods : ACMs were administered to female and male SD rats, as an oral dose of 5000 mg/kg. Animals were monitored for the mortality and changes in the body weight, clinical signs and gross observation during the 14 days after dosing, upon necropsy. Results : We could not find any mortality. Compared with the control group, significant weight change was not observed in the experimental group. First day after administration, compound-colored stool was observed in all rats. After the second day of administration, the more common symptoms were not observed. There were no gross abnormalities in all cases. [ED NOTE: highlight: given the context, this is very vague] Conclusions : The results obtained in this study suggest that the approximate lethal dose of ACM in both female and male rats were considered as over 5000 mg/kg.

• Toxicological Research
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• v.27 no.4
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• pp.217-224
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• 2011

The object of this study was to evaluate the single oral dose toxicity of platycodin D, a saponin from the root of Platycodon grandiflorum in male and female mice. Platycodin D was administered to female and male mice as an oral dose of 2000, 1000, 500, 250 and 125 mg/kg (body wt.). Animals were monitored for the mortality and changes in body weight, clinical signs and gross observation during 14 days after treatment, upon necropsy, organ weight and histopathology of 14 principle organs were examined. As the results, no platycodin D treatment related mortalities, clinical signs, changes on the body and organ weights, gross and histopathological observations against 14 principle organs were detected up to 2000 mg/kg in both female and male mice. Therefore, $LD_{50}$ (50% lethal dose) and approximate LD of playtcodin D after single oral treatment in female and male mice were considered over 2000 mg/kg - the limited dosages recommended by KFDA Guidelines [2009-116, 2009], respectively.

• Journal of Korean Medicine for Obesity Research
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• v.17 no.2
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• pp.96-100
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• 2017

Objectives: Samjung-hwan (SJH) is a Korean herbal formula that has been used for antilipidemic, antioxidant, and antidepressant effects. As a part of safety evaluation, single oral dose toxicity study of modified SJH in Sprague-Dawley (SD) rats was carried out. Methods: Modified SJH extract was administered orally in male and female SD rats at dose of 5,000 mg/kg. After single oral administration of modified SJH, we monitored the changes of mortalities, clinical signs, and body weight daily for 14 days. Gross necropsy findings were also evaluated at the end of the experiment. Results: Modified SJH extract did not induce any toxic signs in the changes of mortalities, clinical signs, and body weight. There were also observed no gross necropsy findings in rats. Conclusions: As results, the approximate lethal dose of modified SJH extract in SD rats was considered to be over 5,000 mg/kg. This suggests that modified SJH is safe herbal formula for the treatment with.

• Toxicological Research
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• v.28 no.2
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• pp.99-102
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• 2012

Bee venom (Apis mellifera L. BV) has been used as a cosmetic ingredient for anti-ageing, anti-inflammatory and antibacterial functions. The aim of this study was to evaluate the acute toxicity after a single dermal administration of BV, BV was administered to 2 groups of Sprague-Dawley (SD) male and female rats (5 animals/group) at doses of 0 and 1,500 mg/kg body weight (BW). Mortality, clinical signs, body weight changes and gross findings were continually monitored for 15 days following the single dose. There were no unscheduled deaths in any groups during the study period. No BV related clinical signs and body weight changes were observed in any groups during the study period. There were no abnormal gross findings at necropsy on day 15 after the treatment. On the basis of the above results, it was concluded that there were no treatment-related effect on mortality, clinical signs, body weight changes and gross findings in SD rats treated with a single dermal dose of BV at dose of 1,500 mg/kg BW. Therefore, the approximate lethal dose of BV was considered to be over 1,500 mg/kg/day for both sexes of rats. BV may provide a developmental basis for a cosmetic ingredient or external application for topical uses.

• The Korea Journal of Herbology
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• v.37 no.3
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• pp.21-27
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• 2022

Objectives : Single oral dose toxicity test of Lythri Herba water extracts (LHWE) in Sprague-Dawley (SD) rat was performed to determine approximate lethal dose (ALD) of LHWE. Methods : This test was progressed according to OECD Guidelines for the Testing of Chemicals : acute oral toxicity. After adaptation of 7 days, SD rats were divided into 2 groups : vehicle control and 5000 mg/kg LHWE-treated group. Each group consisted of 5 female rats and 5 male rats. Vehicle or 5000 mg/kg LHWE was orally administrated once a day. Survival rates, general toxicity, and changes of body weight were investigated for 14 days after administration. On the last day of examination, the weight of all animals was measured and an autopsy was performed. All internal organ abnormalities were checked macroscopically and their findings were recorded. Results : In both groups, dead animals were not observed. During 14 days of administration, abnormal clinical signs were not detected. There was also no significant difference in weight gains between each group. Autopsy analysis showed that one case of the LHWE-treated female group had retention of clear fluid in the uterus; however, it was not considered to be affected by LHWE administration. Moreover, abnormal findings were not discovered in the control male group and the LHWE-treated male group. Conclusions : These results suggest that the ALD of LHWE exceed 5000 mg/kg and single oral administration of LHWE below 5000 mg/kg is nontoxic.

• Toxicological Research
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• v.20 no.4
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• pp.339-348
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• 2004

Paecilomyces sinclairii was administered ad libitum feeding at percentage levels of 0, 1.25, 2.5, 5 and 10 percentage (calculated about 8 g/kg)/feeder for a period of 3 months. There was no observed clinical signs or deaths related to treatment in all groups tested. Therefore, the approximate lethal dose of P. sinclairii was considered to be higher than 8 g/kg in rats. Mild decreases in body weight gain were observed dose-dependently in P. sinclairii treated groups in dose response manner after 2 weeks. Interestingly, the weight of abdominal adipose tissues surrounding epididymides were greatly reduced by this Dongchunghacho, in parallel with the mild increase in body weight gain. However, the absolute weight change of other organs was not observed. There were not significantly different from the control group in urinalysis, ocular examination, hematological, serum biochemical value and histopathological examination. From these results, it is concluded that the no-observed-adverse-effect level (NOAEL) of P. sinclairii is less than 1.25% (1 g/kg) in rats in the present study.

• Toxicological Research
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• v.27 no.4
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• pp.231-240
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• 2011

Gryllus bimaculatus (Gb) was orally administered at doses of 0, 0.04, 0.2, 1 and 5 g/kg bw/day for 13 consecutive weeks. There were no observed clinical signs or deaths related to treatment in all the groups tested. Therefore, the approximate lethal oral dose of G. bimaculatus was considered to be higher than 5 g/kg in rats. Throughout the administration period, no significant changes in diet consumption, ophthalmologic findings, organ weight, clinical pathology (hematology, clinical chemistry, coagulation, and urinalysis) or gross pathology were detected. Minor changes were found in hematological parameters for the 5 g/kg Gb-treated group (triglyceride reduction of 35.8%), but all changes were within normal physiological ranges. Microscopic examination did not identify any treatment-related histopathologic changes in the organs of Gb-treated rats in the high dose group. From these results, one can conclude that the no-observed adverse effect level (NOAEL) of G. bimaculatus is higher than 5 g/kg bw/day in rats.

• Toxicological Research
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• v.20 no.3
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• pp.263-272
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• 2004

This study was to investigate single and repeated-dose toxicities of DFA IV, a new candidate of nutraceutical which has preventive effect on anemia and osteoporosis. In single-dose oral toxicity study, the test article were administered once by gavage to rats at dose level of 0, 2,000 and 5,000 mg/kg. No dead animal, abnormal sign and abnormal necropsy finding was found in control and treated groups. Thus the approximate lethal dose of DFA IV was considered to be higher than 5,000 mg/kg in rats. In four week repeated dose oral toxicity study, the test article was administered once daily by gavage to rats at dose levels of 0, 500, 1,000 and 2,000 mg/kg. No abnormality was observed in mortality, clinical findings, body weight changes, food and water consumptions, opthalmoscopic findings, hematological findings, necropsy findings, organ weights and histopathological findings. In urinalysis, specific gravity was increased in 2,000 mg/kg groups of male rats. In serum biochemical analysis, creatine phosphokinase was increased in all treatment groups of male rats. These increases in urine specific gravity and serum creatine phosphokinase activity were not accompanied with related signs such as histopathological changes or clinical findings. In conclusion, four week repeated oral dose of DFA IV to rats did not cause apparent toxicological change at the dose of 500, 1,000 or 2000 mg/kg body weight. Thus it is suggested that no-observed-adverse-effect level (NOAEL) of DFA IV in rats would be 2,000 mg/kg/day body weight.

• Korean Journal of Pharmacognosy
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• v.50 no.3
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• pp.205-218
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• 2019

This study was conducted to investigate the toxicity symptoms and approximate lethal dose (ALD) of Oplopanax elatus (Nakai) Nakai hydrothermal extract powder by single oral dose toxicity and 4 weeks of repeated oral dose determination. The Sprague-Dawley (SD) male and female rats were treated with 1,250 (low- dosage group), 2,500 (medium- dosage group) and 5,000 (high- dosage group) mg/kg. In the single oral dose toxicity test, no dead animals and toxic symptoms were observed during the experiment. And there were no related with anomalies in normal weight changes and autopsy results. In the four-week repeated oral dose determination test, no death animals and toxicity symptoms were observed during the experiment, and there were no abnormal results in weight changes, feed and negative intake measurements. Results of eye examination, urinalysis, hematological values and serum biochemical values, gross findings and absolute organ were not of singularity. These result demonstrated that no toxic symptoms were observed by the test substance Oplopanax elatus (Nakai) Nakai hydrothermal extract powder under this test condition, and the non-toxic content is determined to be 5,000 mg/kg/day.

• The Korea Journal of Herbology
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• v.34 no.3
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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.