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KMID : 0869420210190010017
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Journal of Jeahan Oriental Medical Academy
2021 Volume.19 No. 1 p.17 ~ p.39
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Rat single oral dose toxicity test of Bojungikki-tang (BJIKT)
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Kim Joo-Ik
Song Chang-Hyun
Park Soo-Jin
Choi Seong-Hun
Ku Sae-Kwang
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Abstract
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Objectives : The objective of this study was to obtain acute (single) oral dose toxicity information of Bojungikki-tang (BJIKT), prepared and standardized by Aribio Ltd. (Seungnam, Korea), in female and male Sprague-Dawley rats as a process to develop of natural origin medicinal ingredient or food itself.
Materials and methods : In order to investigate the toxicity and identify target organs, BJIKT were once orally administered to female and male Sprague-Dawley rats at dose levels of 2000, 1000, 500 and 0 (vehicle control) mg/kg (body weights) in a volume of 10 ml/kg, dissolved in distilled water, and the mortality and changes on the body weight and clinical signs were monitored during 14 days after treatment with gross observation, changes on the organ weights and histopathology of principle organs based on the recommendation of Organization for Economic Co-Operation and Development (OECD) Guideline 423 based Korea Food and Drug Administration (KFDA) Guideline (2015-082, 2015), as compared with those of equal genders of vehicle control rats. Because there are no available toxicological data after oral treatment in female and male rats of BJIKT, the highest dosage used in the present study were selected as 2,000 mg/kg in a volume of 10 ml of distilled water - the limited dosages of rodents, and 1,000 and 500 mg/kg were selected as middle and lower dosage groups according to OECD Guideline 423 based KFDA Guidelines (Notification No. 2015-082, 2015). In addition each female and male vehicle controls were added in this experiment. Principal organs for weighing : Lung, Heart, Thymus, Liver, Left Kidney, Left Adrenal Gland, Spleen, Left Testis/Ovary, Splenic lobe of Pancreas, Brain, Urinary bladder, Left Epididymis/total Uterus, Prostate and Left Submandibular Lymph node [Total 16 organs] Specific target organs for histopathology : Brain (Cerebrum, Cerebellum and Medulla oblongata), Heart, Thymus, Lung, Testis, Epididymis (head parts), Uterus, Ovary, Left-kidney, Left-adrenal glands, Spleen, Liver-left lateral lobe, Pancreas-splenic part, Digestive tracts (Esophagus, Fundus, Pylorus, Duodenum, Jejunum, Ileum, Cecum, Colon and Rectum), Left-submandibular lymph nodes, Urinary bladder and Prostate [Total 27 organs].
Results : As the results of single oral treatment of BJIKT on the female and male Sprague-Dawley rats, no treatment related mortalities were observed within 14 days after end of treatment up to 2,000 mg/kg, the limited dosage of rodents in the both genders, and also no BJIKT treatment related changes on the body and organ weights, clinical signs, necropsy and histopathological findings were detected, in this experiment.
Conclusion : The results obtained in this study suggest that the BJIKT, prepared and standardized by Aribio Ltd. (Seungnam, Korea), is non-toxic in rats and is therefore, likely to be safe for clinical use. The 50% lethal dose (LD50) and approximate LD in rats after single oral dose of BJIKT were considered over 2,000 mg/kg, the limited dosage of rodents in both female and male Sprague-Dawley rats, respectively. In addition, no specific target or clinical sings were detected in the present study.
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KEYWORD
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Bojungikki-tang (BJIKT), Single oral dose toxicity test, Female and male Sprague-Dawley rat, Histopathology
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