Objective : The objective of this study was to access the safety of Artemisia iwaymogi Kitamura extracts that have been used as oriental medicine to the liver disease on the fertility and early embryonic development of male and female Wistar rats when administered by oral gavage with their potential hepatotoxicity.
Method : Males were administerd 4 weeks before pairing and 2 weeks after mating including the mating periods up to termination after necropsy of the majority of the females. Females were dosed 2 weeks before pairing, and from Day 0 to Day 7 of gestation. It was conducted in accordance with the recommendations of the KFDA Guideline for Detection of Toxicity to Reproduction for Medicinal Products.
Result : No Artemisia iwoyomogi Kitanura extracts treatment-related changes of clinical signs, mortalities, estrous cycle, pre-coital intervals, mating index, conception rate, fertility index, gross findings, histopathological observation, corpora lutea number, implantation site number, live fetus number, number of resorption embryo and gre- and post-implantation loss were demonstrated in all dosed levels in this study. Although the body weight gains, food consumption and absolute organ weights of epididymis, prostate, seminal vesicle, testis, ovary and liver were significantly increased in Mxxlmg/kg -dosing groups, and the relative organ weights were not changed. So it was concluded that this increase was natural according to the growth. And no changes of serum AST, ALT, LDH and ALP levels were demonstrated in all dosed levels in this study.
Condustions : it is considered that the NOAEL(No Observed Adverse Effect Level) for fertility and early embryonic development toxicity of Artemisia iwaymogi Kitamura extracts was up to 2000㎎/kg/day because there no changes of other fertility and early embryonic developmental index were demonstrated.
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