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

• Toxicological Research
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• v.18 no.3
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• pp.285-292
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• 2002

The repeated toxicity of Gleditschia-saponin produced and provided by S.S. Bio-Tech Bench Co. was evaluated in Sprague-Dawley rats. Gleditschia-saponin was administered to rats by oral route at dose levels of high (180 mg/kg/day), medium (90 mg/kg/day) and low (45 mg/kg/day) once a day for 14 days. Saline was administered to another group of rats as control. Each group was consisted of 5 male and female rats. There were no dose-related changes in clinical findings, food and water consumption, organ weights, urine analysis, biochemical examination and hematological findings in all groups of animals treated with Gleditschia.- saponin, except body weights. Body weighs in male and female rats were increased significantly (p < 0.05) from day 4 to 14 in low, middle and high dose groups than control group. Body weight in high dose group was increased higher than control or low, middle dose groups on day 14. Gross and histopathological findings revealed no evidence of specific toxicity to Gleditschia.-saponin. Therefore, it was concluded that Gleditschia-saponin had no toxic or side effects in Sprague-Dawley rats in an repeated oral toxicity tests.

• Korean Journal of Veterinary Research
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• v.48 no.4
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• pp.401-411
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• 2008

This study was performed to evaluate repeated-dose oral toxicities of Flos lonicerae extract in Fischer 344/n rats. Flos lonicerae was administered orally to rats at dose levels of 0, 37, 111, 333, 1,000 and 2,000 mg/kg/day. Each group consisted of 10 rats of each gender. The Flos lonicerae extract was given once a day, 5 times a week, for 90 day repeatedly. This study was conducted in accordance with the Protocol of Korea National Toxicology Program and The Standards of Toxicity Study for Medicinal Products. In the present study, there were no toxicologically significant changes in mortality, clinical signs, body weight gains, ophthalmoscopy, urine analysis, hematology, serum biochemistry, necropsy findings, organ weights, histopathology, estrus cycle and sperm examination of all animals treated with Flos lonicerae extract. These results suggest that the oral no observed adverse-effect level of the test item, Flos lonicerae extract, in rats is higher than 2,000 mg/kg/day in both genders. The target organs were not established.

• Korean Journal of Veterinary Research
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• v.49 no.1
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• pp.23-34
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• 2009

This study was performed to evaluate repeated-dose oral toxicities of Chelidonium majus extract in Fischer 344/N rats. Chelidonium majus extract was administered orally to rats at dose levels of 0, 25, 74, 222, 666 and 2,000 mg/kg/day. Each group consisted of 10 rats of each gender. The Chelidonium majus extract was given once a day, 5 times a week, for 90 day repeatedly. This study was conducted in accordance with the Protocol of Korea National Toxicology Program (issued by National Institute of Toxicological Research) and The Standards of Toxicity Study for Medicinal Products (issued by Korea Food and Drug Administration). In the present study, There were no toxicologically significant changes in mortality, clinical signs, body weight gains, ophthalmoscopy, urine analysis, hematology, serum biochemistry, necropsy findings, organ weights, histopathology, estrus cycle and sperm examination of all animals treated with Chelidonium majus extract. These results suggest that the oral no observed adverse-effect level of the test item, Chelidonium majus extract, in rats is higher than 2,000 mg/kg/day in both genders. The target organs were not established.

• Journal of Korean Medicine for Obesity Research
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• v.18 no.1
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• pp.36-49
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• 2018

Objectives: The study is aimed at evaluating the possible toxicity in 90-day repeated oral administration of modified Samjung-hwan (mSJH) in Sprague-Dawley (SD) rats. This study was conducted to detect the no-observed adverse effect level (NOAEL). Methods: Modified SJH extract was administered orally in male and female SD rats at dose of 0, 1,000, 2,000, 4,000 mg/kg. Each group consisted of 10 rats of each gender. The modified SJH extract was given once a day for 90 days. We monitored the changes of mortalities, clinical signs, body weight changes, food consumption, ophthalmologic findings, urine analysis, hematology, serum biochemistry, necropsy findings, organ weights, histological markers of all animals treated with modified SJH extract during the study period. Results: There were no toxicologically significant changes in mortalities, clinical signs, body weight gains, food consumption, ophthalmologic findings, urine analysis, hematology, serum biochemistry, necropsy findings, organ weights, histological markers in any of rats tested. Conclusions: The NOAEL of the modified SJH extract in male rats and no observed effect level (NOEL) in female rats are considered 4,000 mg/kg.

• Proceedings of the Korean Society of Toxicology Conference
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• 2005.05a
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• pp.207-207
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• 2005

• Journal of Life Science
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• v.26 no.10
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• pp.1153-1162
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• 2016

Termitomyces albuminosus (Berk.) Heim is a well-known wild edible mushroom in the southern region of China. Novel cerebrosides, termed termitomycesphins, isolated from EtOH extract of T. albuminosus have shown significant neuritogenic activity. Neurotrophic factors have been targeted as potential therapeutic drugs for the treatment of neurodegenerative disorders. However, before expanding their applications to include food or therapeutic agents in Korea, a safety evaluation of T. albuminosus is needed. Herein, in a repeated-dose 90-day oral toxicity study, rats were exposed to a basal diet of powder ground from dried T. albuminosus at dose levels of 5%, 2.5%, 1.25%, and 0%. The following endpoints were evaluated: clinical observation, body weight, gross and microscopic pathology, clinical chemistry, and hematology. Significant dose-dependent increases in the weight of the left kidney were observed, possibly due to the test substance. Based on toxicity-decision criteria for minor compound-related changes (no observed adverse effect level [NOAEL] and no observed effect level [NOEL]), NOAEL was observed in male rats at a dose of 5% of dried T. albuminosus powder, and NOEl was observed in female rats at the same dose. The results point to the safety and potential use of T. albuminosus as a nontoxic neurotrophic factor.

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

• Journal of the Korean Society of Food Science and Nutrition
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• v.40 no.6
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• pp.824-831
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• 2011

This study was to investigate 90-day repeated-dose toxicities of 50 kGy irradiated methanol extract powder of red ginseng in ICR mice. The test materials (methanol extract powder of red ginseng with or without 50 kGy irradiation) were administered by gavage to male and female ICR mice at dose levels of 0, 125, 250 and 500 mg/kg/day for 90 days. In the results, no abnormality was observed in mortality, clinical findings, body weight changes, food consumptions, opthalmoscopic findings, necropsy findings and histopathological findings. Although the minor changes in blood and biochemical parameters were observed, they were not dose dependent and not affected by gamma irradiation. In conclusion, 90-day repeated oral dose of the methanol extract powder of red ginseng and 50 kGy irradiated methanol extract powder of red ginseng to ICR mice did not cause apparent toxicological change at the dose of 125, 250 and 500 mg/kg body weight.

• Journal of the Korean Society of Food Science and Nutrition
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• v.40 no.5
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• pp.704-711
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• 2011

Traditionally, mistletoes have been used as immunostimulant for the management of certain diseases such as cancer with high profile immune depleting potentials. In order to examine the safety of the 20 kGy irradiated cold water extract powder of mistletoes, we performed a 90-day repeated-dose toxicity study with ICR mice. The mice were treated with daily doses of the 20 kGy irradiated cold water extract powder of mistletoes by gavage at 0, 20, 100, and 500 mg/kg/day for 90 consecutive days. We recorded clinical signs of toxicity, body weight, organ weights, histological changes in target organs, hematology, and clinical blood chemistry analysis data for all mice. There were no significant changes in body and organ weights during the experimental period. The hematological analysis and clinical blood chemistry data revealed no toxic effects from the 20 kGy irradiated cold water extract powder of mistletoes. Pathologically, neither gross abnormalities nor histopathological changes were observed between the control and treated mice of both sexes. Collectively, these data suggest that the 20 kGy irradiated cold water extract powder of mistletoes have a high margin of safety.