형질전환 설치류의 체세포와 생식세포를 이용한 유전변이시험 평가
Evaluation of Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays
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In this study, options for the additionally recognized genotoxicity test methods at the domestic Good Laboratory Practice (GLP) level have expanded as the “Standards for Toxicity Studies of Drugs” and were revised as the GLP of the domestic applied. This study aimed to establish a new test method to compensate for the shortcomings of the existing genotoxicity test methods and to expand the test method selection in order to perform a test suitable for the substance. Therefore, “Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays” was performed. The test was conducted according to the guidelines of following the minimum comparative substance at least. After administration of the test substances (N-Ethyl-N-ethylurea, Sodium chloride) for 4 weeks, organs were extracted by sacrificing on the 3rd, 28th and 49th days. The Genomic DNA was extracted from the liver, testis, and epididymis. The DNA sequencing was performed through gpt assay, and the mutation rate was calculated. The genotoxicity of the test substance was determined using the calculated mutation rate. As a result, the determination of genotoxicity of each substance was consistent with the OECD guidelines. Through this test, reproducibility of the experiment was confirmed.
Abstract
In this study, options for the additionally recognized genotoxicity test methods at the domestic Good Laboratory Practice (GLP) level have expanded as the “Standards for Toxicity Studies of Drugs” and were revised as the GLP of the domestic applied. This study aimed to establish a new test method to compensate for the shortcomings of the existing genotoxicity test methods and to expand the test method selection in order to perform a test suitable for the substance. Therefore, “Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays” was performed. The test was conducted according to the guidelines of following the minimum comparative substance at least. After administration of the test substances (N-Ethyl-N-ethylurea, Sodium chloride) for 4 weeks, organs were extracted by sacrificing on the 3rd, 28th and 49th days. The Genomic DNA was extracted from the liver, testis, and epididymis. The DNA sequencing was performed through gpt assay, and the mutation rate was calculated. The genotoxicity of the test substance was determined using the calculated mutation rate. As a result, the determination of genotoxicity of each substance was consistent with the OECD guidelines. Through this test, reproducibility of the experiment was confirmed.
참고문헌 (16)
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