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KMID : 1145320140030010019
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Journal of Korea Immuno-yakchim Society
2014 Volume.3 No. 1 p.19 ~ p.26
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Single Intramuscular Dose Toxicity Study of CA-YAKCHIM in Sprague-Dawley Rats
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Jung Chul
Lee Ma-Seong
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Abstract
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Objectives : The purpose of this study was to investigate the toxicity and to determine approximate lethal dose of the CA-YAKCHIM, KOREA IMMUNO-YAKCHIM SOCIETY, following a single intramuscular injection to 6-week old male and female Sprague-Dawley rats.
Methods : Test groups consisted of one dosing group at a dose of 1.0 mL/animal and one control group (saline), and 5 males and 5 females were assigned to each group. All animals were monitored for clinical signs and body weight changes during the 14-day observation period after administration. They were subjected to gross necropsy at the end of the observation period. At necropsy, necropsy findings and local tolerance test at the injection site were conducted.
Results : All animals in the 1.0 mL/animal group survived the duration of the study. No CA-YAKCHIM-related effects were evident in clinical signs and necropsy findings in any animals in the 1.0 mL/animal group. In local tolerance test at the injection site, no CA-YAKCHIM-related effects were evident in any animals in the 1.0 mL/animal group.
Conclusions : In this study, the approximate lethal dose of the CA-YAKCHIM was considered to be greater than 1.0 mL/animal in male and female rats.
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KEYWORD
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CA-YAKCHIM, IMMUNO-YAKCHIM, Toxicity, A single intramuscular injection, Nam Sang Cheon
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