Toxicological Study of SU-Eohyeol Pharmacopuncture in an In Vivo Micronucleus Test in Sprague-Dawley Rats

Abstract

Objectives : The purpose of this study was to evaluate the potential of the test substance, SU-Eohyeol Pharmacopuncture (SUEP), to induce micronuclei in bone marrow cells of Sprague-Dawley (SD) Rats. Methods : The dose range preliminary study was performed first. 1 ml/animal was selected as the high dose of this study. Two additional lower dose levels (0.5 and 0.25 ml/animal) were produced by applying a geometric ratio of 2. In addition, the positive and negative control groups were set. Then, after intramuscular administration (1 ml/animal) of SUEP to 8-week-old male SD rats, an in vivo micronucleus test was performed to evaluate the induction of micronuclei in SD rat bone marrow cells. Results : As a result of the main study, the incidence of micronucleated polychromatic erythrocytes (MNPCE) in polychromatic erythrocytes (PCE) in the test substance SUEP groups was not statistically significantly different from the negative control group. In addition, the ratio of PCE to total erythrocytes in the test substance SUEP groups was not statistically significantly different from the negative control group. In the positive control group, the incidence of MNPCE in PCE was statistically significantly increased when compared to the negative control group. The ratio of PCE to total erythrocytes in the positive control group was not statistically significantly different from the negative control group. Conclusions : Based on these results, the test substance, SUEP, did not have any potential to induce micronuclei formation in bone marrow cells of rats under the conditions of this study.

Evaluation of Genotoxicity of SU-Eohyeol Pharmacopuncture Using an In Vitro Chromosome Aberration Test in Chinese Hamster Lung Cell

“…SUEP is a pharmacopuncture agent with a concentration of 305 mg/mL mixed with nine herbs ( Table 1 ). SUEP was manufactured by mixing and filtering after each extraction process using centrifugal partition chromatography (CPC) and other medicinal herbs at an external herbal dispensary (EHD), meeting Korean Good Manufacturing Practice standards (Namsangcheon EHD, Yongin, Korea) [ 13 ]. SUEP was provided in a transparent vial containing a pale-yellow liquid and was refrigerated at 4.2-5.4℃.…”

“…Currently, the most widely performed three-battery assays include the bacterial reverse mutation test, in vitro chromosomal aberration assay, and in vivo micronucleus assay [ 12 ]. The results for the genotoxicity of SUEP in two of the three battery assays have already been published [ 13 , 14 ], yet no studies using mammalian cells for chromosomal abnormalities have been published.…”