• Toxicological Research
• /
• v.20 no.4
• /
• pp.349-357
• /
• 2004

This study was performed to evaluate repeated-dose toxicities of CONP01 in Sprague-Dawley rats. CONP01, a new antiarthritic agent was administered orally to rats at dose levels of 0, 125, 500 and 2,000 mg/kg/day for 4 weeks. In present study, there were no dose response changes in mortality, clinical signs, body weight changes, food and water consumption, ophthalmoscopy, organ weights, urine analysis, hematological findings, and biochemical examination of all animals treated with CONP01. Gross and histopathological findings revealed no evidence of specific toxicity related to CONP01. These result suggest that no observed adverse effect level (NOAEL) of CONP01 may be over 2,000 mg/kg in rats.

• Proceedings of the Korea Society of Environmental Toocicology Conference
• /
• 2002.10a
• /
• pp.172-172
• /
• 2002

Previously, we reported a novel polymeric micellar solubilizer, Aceporol 330, that showed relatively low toxic effects when it was compared with that of Cremophor EL which is currently being used for paclitaxel. In this study, we have developed a new micellar solubilizer, Aceporol 460, that has 3-4 times higher loding capacity for paclitaxel than Aceporol 330. The single-dose and the repeated-dose toxicity of Aceporol 460 were evaluated in ICR mice. For single dose toxicity test, male and female mice were randomly assigned to one of five study groups to receive, and injected intravenously with dosages of 0, 3, 4mL Cremophor EL/kgbody weight, and 3, 4mL Aceporol 460/kg body weight, respectively. In both male and female mice, LD50 for Aceporol 460 can not he determined even at the maximal administrable dosage, 4mL/kg due to the high viscosity of chemical and there was no significant change in body weight, hematological and serum biochemical analysis, organ weight, and histopathological examination compared with that of Cremophor EL. For the repeated dose toxicity test, male and female mice were given the dosage of 0, 1.6mL Cremophor EL/kgbody weight/day, and 1.6mL Aceporol 460/kg body weight/day for 2 weeks. Results of repeated dose toxicity tests for 2 weeks suggested that Aceporol 460 treated group show no significant toxicological findings with body weight, hematological and serum biochemical analysis, organ weight, urinalysis, and ophthalmoscopic and histopathological examination compared with that of Cremophor EL. These results indicate that Aceporol 460 have higher paclitaxeL-loading capacity than Aceporol 330 and less toxic effects than Cremophor EL in male and female mice.

• Proceedings of the PSK Conference
• /
• 2003.04a
• /
• pp.181.2-182
• /
• 2003

Single and 28-day repeated dose toxicity studies of botulinum toxin type A(BTA) were carried out in ICR mice and SD rats. respectively. In the single dose toxicity study. BTA was injected intraperitoneally to male and female mice at a single dose of 40, 59, 89, 133 and 200 ng/kg. All animals died from 59 ng/kg. Some clinical signs were observed in most of both sexes from 59 ng/kg, but no signs were seen in all animals at 40 ng/kg. (omitted)

• Biomolecules & Therapeutics
• /
• v.6 no.2
• /
• pp.182-190
• /
• 1998

DA-3585 is a recombinant human erythropoietin produced by Dong-A pharmaceutical Co. Ltd. using recombinant DNA technique. Recently, recombinant human erythropoietin (rHu-EPO) has been used to treat various types of anemia. In this study, we examined acute and subacute toxicity of DA-3585 in rats. DA-3585 was intravenously administered to rats at dose levels of 0, 6,250, 12,500 and 25,000 lU/kg for single dose toxicity study and at dose levels of 0,100,500 and 2,500IU/kg daily for 4 week-repeated dose toxicity study. In the single dose toxicity study, there were no death, clinical signs and changes in body weight gain related to the treatment. Necropsy revealed no evidence of toxicity related to DA-3585, In the repeated dose toxicity study, all the rats survived throughout the study. There were no treatment-related changes in clinical signs, food and water intake, and body weight. Hematological examination showed increases in the number of erythrocytes, hemoglobin concentration, hematocrit value and mean corpuscular volume, and decrease in the number of platelet in 500 and 2,500 lU/kg dosed groups. Extramedullary hematopoiesis in the spleen and erythroid hyperplasia in the bone marrow were noted as treatment-related histological changes. Toxicologically significant changes were not observed in blood biochemistry, urinalysis, organ weights and in any other examinations. The treatment-related changes observed in this study were hematological or histological changes associated with pharmacological effects of DA-3585. On the basis of the results of this study, LD5n value of DA-3585 was above 25,000 lU/kg and the no-observed-adverse-effect-level was estimated to be 100 lU/kg.

• Korean Journal of Acupuncture
• /
• v.36 no.2
• /
• pp.127-138
• /
• 2019

Objectives : This study was carried out in order to toxicity and safety of Drosera Rotundifolia L. pharmacopuncture in BALB/c mice. Methods : In order to investigate toxicity and safety of Drosera Rotundifolia L. pharmacopuncture, BALB/c mice were chosen in these studies and injected to ST36. In 50% Lethal Dose (LD 50) study, mice were divided into 8 groups. Doses of pharmacopuncture at 300, 600, 1,200, 2,400, 3,600, 4,800, 6,000, 7,200 mg/kg were given to the each group. we observed mortality and toxic signs for 7 days after injection. In single-dose toxicity, mice were divided into 4 groups. Doses of pharmacopuncture, 300, 600, 1,200 mg/kg, were administered to the experimental group. And a dose of normal saline, 0.2 ml was administered to the control group. We observed mortality and toxic signs for 14 days after injection. In repeated-dose toxicity for 4 weeks, mice were divided in 4 groups. Doses of pharmacopuncture, 150, 300, 600 mg/kg, were administered to the experimental group. And a dose of normal saline, 0.2 ml, was administered to the control group. We observed mortality, toxic signs, body weight, hematological values et al. Results : The LD 50 of Drosera Rotundifolia L. pharmacopuncture was 4,800 mg/kg. In single-dose toxicity, no deaths, no toxic signs occurred in any of groups. In repeated-dose toxicity for 4 weeks, no deaths, no toxic signs occurred in any of groups. Conclusions : No Observed Adverse Effect Level (NOAEL) of Drosera Rotundifolia L. pharmacopuncture injection for 4 weeks was more than 600 mg/kg.

• Korean Journal of Acupuncture
• /
• v.35 no.3
• /
• pp.139-148
• /
• 2018

Objectives : This study was performed to examine the toxicity on the long term procedure of Aconitum ciliare Decaisne pharmacopuncture(ADP) solution. Methods : To evaluate the long term toxicity of 3 different repeated doses, 60, 150, and 300 mg/kg/day for 13 weeks were injected into BALB/c mice, respectively. The ADP solution was injected into near ST36 of the right leg and normal saline of the same volume was used for the vehicle control group. To evaluate the toxicity of 60, 150, and 300 mg/kg of repeated doses for 13 weeks, toxic symptoms, weight measurement, hematological test, blood biochemical test, visual examination and weight measurement of major organs, and histopathological test were conducted. Results : No significant changes in toxic symptoms, weight measurement, hematological test, blood biochemical test, visual examination and weight measurement of major organs, and histopathological test were observed in different doses of ADP solution treated groups compared to vehicle control group. Conclusions : As a result, repeated dose at a concentration of 300 mg/kg or less is considered to be not harmful for clinical treatment.

• Proceedings of the Korea Environmental Mutagen Society Conference
• /
• 2004.05a
• /
• pp.96-96
• /
• 2004

• Proceedings of the Korea Environmental Mutagen Society Conference
• /
• 2004.05a
• /
• pp.133-134
• /
• 2004

• The Korea Journal of Herbology
• /
• v.36 no.6
• /
• pp.27-37
• /
• 2021

Objectives : In the current study, we performed the 13-week repeated oral dose toxicity test and a 4-week recovery 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 no observed adverse effect level (NOAEL). Methods : The animal study was performed according to OECD guidelines for the testing of chemicals section 4 health effects test No.408 repeated dose 90-day oral toxicity study in rodents (03 October 2008). In the repeated dose toxicity study, SCP was orally administered to female and male rats at dose levels of 1,000, 2,000, and 4,000 mg/kg/day for 13-week. The control group and high dose (4,000 mg/kg/day) group were then monitored for 4 extra weeks to determine recovery time after the study period. 1) Results : Compared with the control group, there were no treatment-related adverse effects in clinical signs, body weight, hematology, serum biochemistry (Aspartate aminotransferase, Alanine aminotransferase, Alkaline phosphatase, 𝛾-Glutamyl transpeptidase, Blood urea nitrogen, Creatinine, Glucose, Total cholesterol, Total protein, Creatine phosphokinase, Albumin, Total bilirubin, Triglyceride, Inorganic phosphorus, Albumin/Globulin ratio, Calcium ion, Sodium ion, Potassium ion, Chloride ion), necropsy findings and organ weight (Ovary, Adrenal gland, Pituitary, Thymus, Prostate, Testis, Epididymis, Spleen, Kidney, Heart, Lung, Brain, Liver) at any dose tested. Conclusions : Taken together, these results suggest that the NOAEL of SCP in both genders was considered as over 4,000 mg/kg. Results from this study provide scientific evidence for the safety of SCP.

• Toxicological Research
• /
• v.29 no.4
• /
• pp.263-278
• /
• 2013

The silkworm extract powder contain 1-deoxynojirimycin (DNJ), a potent ${\alpha}$-glycosidase inhibitor, has therapeutic potency against diabetes mellitus. Therefore, natural products containing DNJ from mulberry leaves and silkworm are consumed as health functional food. The present study was performed to evaluate the safety of the silkworm extract powder, a health food which containing the DNJ. The repeated toxicity studies and gentic toxicity studies of the silkworm extract powder were performed to obtain the data for new functional food approval in MFDS. The safety was evaluated by a single-dose oral toxicity study and a 90 day repeated-dose oral toxicity study in Sprague-Dawley rats. The silkworm extract powder was also evaluated for its mutagenic potential in a battery of genetic toxicity test: in vitro bacterial reverse mutation assay, in vitro chromosomal aberration test, and in vivo mouse bone marrow micronucleus assay. The results of the genetic toxicology assays were negative in all of the assays. The approximate lethal dose in single oral dose toxicity study was considered to be higher than 5000 mg/kg in rats. In the 90 day study, the dose levels were wet at 0, 500, 1000, 2000 mg/kg/day, and 10 animals/sex/dose were treated with oral gavage. The parameters that were monitored were clinical signs, body weights, food and water consumptions, ophthalmic examination, urinalysis, hematology, serum biochemistry, necropsy findings, organ weights, and histopathological examination. No adverse effects were observed after the 90 day administration of the silkworm extract powder. The No-Observed-Adverse-Effect-Level (NOAEL) of silkworm extract powder in the 90 day study was 2000 mg/kg/day in both sexes, and no target organ was identified.