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KMID : 0379520070230040405
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한국독성학회지
2007 Volume.23 No. 4 p.405 ~ p.413
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Single-Dose Toxicity and Four Week Repeated-Dose Toxicity Study on Tensolin-F® (3,9-diferuloyl-6-oxopterocarpen)
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Kim Keun-Su
Park Seong-Min
Lee Nam-Jin
Pyo Hyeong-Bae
Chai Hee-Youl
Jung Yu-Ri
Lin Chun-Mei
Kim Sun-Hee
Lee Hye-Young
Kang Jong-Koo
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Abstract
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This study was to investigate single and repeated-dose toxicities of Tensolin-F®, an anti-wrinkle agent, in Sprague-Dawley (SD) rats or ICR mice. In single-dose oral toxicity study, the test materials were administered once by gavage to male and female SD rats at dose levels of 0 and 2,000 ㎎/㎏. No dead animals and abnormal necropsy findings were found in control and Tensolin-F® treated group. Therefore, the approximate lethal dose of Tensolin-F® was considered to be higher than 2,000 ㎎/㎏ in rats. In the 4-week repeated oral toxicity study, the test material was administered once daily by gavage to male and female ICR mice at dose levels of 0, 25, 50 and 100 ㎎/㎏/day for 4-weeks. In the results, no abnormality was observed in mortality, clinical findings, body weight changes, food and water consumptions, opthalmoscopic findings, necropsy findings, histopathological findings. In hematological analysis, there was a trend of increase in reticulocyte at male 25 ㎎/㎏, although such changes were in normal ranges. On the other hand, there was a trend of decrease in hemoglobin at female 50, 100 ㎎/㎏, such changes were in normal ranges. In addition, serum biochemical parameters including sodium, BUN and chloride increased at 25, 50 and 100 ㎎/㎏. Relative organ weights of right testis, brain, lung and left epididymis were increased in 100 ㎎/㎏ groups of male rats in contrast to not change in female groups. However, these changes of relative organ weights, hematological and serum biochemical parameters were not accompanied with related signs such as histopathological changes or clinical findings. In conclusion, 4-week repeated oral dose of Tensolin-F® to ICR mice did not cause apparent toxicological change at the dose of 25, 50, 100 ㎎/㎏ body weight. Consequently the no-observed-adverse-effect level (NOAEL) for Tensolin-F® in ICR mice following gavage for at least 4-week is higher than 100 ㎎/㎏/day.
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KEYWORD
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Tensolin-F®, Ferulic acid, Single-dose oral toxicity, , 4-week repeated-dose toxicity
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