Objectives : The objective of this study was to obtain acute (single) oral dose toxicity information of Persicariae Rhizoma (Persicaria tinctoria H. Gross; PR) aqueous extracts (yield = 12.0) contains indigo (0.043%) and indirubin (0.009%) in female and male ICR mice as a process to develop of natural origin medicinal ingredient or food itself, and further clarifies their safety for clinical use.
Method : In order to investigate the toxicity and identify target organs, PR aqueous extracts was once orally administered to female and male ICR mice at dose levels of 2,000, 1,000, 500 and 0 (vehicle control) ㎎/㎏ (body weights) in a volume of 20 ㎖/㎏, 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 KFDA Guidelines [2015-082, 2015], as compared with those of equal genders of vehicle control mice.
Result : As the results of single oral treatment of PR aqueous extracts, no treatment related mortalities were observed within 14 days after end of treatment up to 2,000 ㎎/㎏, the limited dosage of rodents in the both genders, and also no PR aqueous extracts treatment related changes on the body and organ weights, clinical signs, necropsy and histopathological findings were detected as compared with equal genders of vehicle control, in this experiment.
Conclusion : The results obtained in this study suggest that PR aqueous extracts is nontoxic in mice and is therefore, likely to be safe for clinical use. The LD50 and ALD of PR aqueous extracts in both female and male mice after single oral treatment were detected as over 2,000 ㎎/㎏ with no specific target organs or side effects in this experiment.1)
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