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Genetic Toxicology Test
Genetic Toxicology
Genetic toxicology test observes the formative change or functional disorder by test substance directly damaging the DNA or chromosome. Also, it is a test to find out the carcinogenicity and mutagenicity of drug, agricultural pesticide and various chemicals.
Korea Institute of Toxicology is a consigned facility to conduct genetic toxicology test based on OECD guideline first in Korea, and conducts genetic toxicology for drug, agricultural pesticide and various chemicals with rich experience. Also, in case of clients' requests, we consult regarding various genetic toxicology tests. Especially, the genetic toxicology test is one of the most significant test that is mandatory at the stage of substance screening when developing new drug or chemicals to save costs from carcinogenicity test.
Field of Test
As there are numerous mechanism of toxicology, to examine the correct genetic toxicology of test substance, several genetic toxicology tests are conducted in Battery. Currently, the most common 3-batter test method includes bacterial reverse mutation test, in vitro chromosomal aberration assay, invivo micronucleus assay. Each tests abides by the guidelines of test substance registration institutions (OECD, ICH, EPA, US-FDA, MFDS, JMHLW and JMAFF) and GLP regulation.
Bacterial Reverse Mutation Test, Ames Test, OECD TG 471
- Bacterial reverse mutation test is a test method that measures genetic toxicity by checking if the test substance converts microorganism with disrupted amino acid composition to amino acid synthetic strain. It was developed by Dr. Bruce Ames in the early 70s, and also known as Amestest. This test uses more than 5 strains to measure the genetic damage on the single base level of DNA. In general, the test uses 5 strains such as Salmonella typhimurium TA98,TA100, TA1535, TA1537 and Escherichia coli WP2 uvrA, and also use Salmonella typhimurium TA102 in accordance with the property of test substance. This test method is quick, simple and has very close correlation with carcinogenicity test which is widely used in the safety test of drug, food additives, agricultural pesticide, general chemicals and at the early screening stage of new drug development.
In vitro Chromosomal Aberration Assay, OECD TG 473
- This test measures the structural abnormality of chromosome caused by the test substance, and generally uses Chinese Hamster Lung(CHL), Chinese Hamster Ovary(CHO) cell, the mammal cell.
In vivo Micronucleus Assay, OECD TG 474
- This test detects the chromosome damage or mitotic apparatus damage caused by bone marrow of rodent or peripheral blood cell injected with test substance. It measures cytogenetic damage based on the formation of micronucleus including the entire chromosome or piece of chromosome.
In vitro Micronucleus Assay, OECD TG 487
- In vitro micronucleus assay measures substance that cause clastogenic and aneugenic of chromosome using mammal cell, and measures the micronucleus that exists cytoplasm of interphase cell. It is a test method to measure clastogenic and aneugenic of chromosome caused by test substance, and mainly uses CHL cell, the mammal cell, TK6 and Human Fibroblasts (IMR90,WI-38), the human cell.
In vivo Comet assay Single Cell Gel Electrophoresis, OECD TG489
- This tests assess the damage of DNA from individual cell by putting the single cell suspension to lowmelting agar gel, dissolving and conducting electrophoresis in alkali(pH>13) condition. It is also called comet assay as the DNA movement pattern using electrophoresis gel looks like comet. We generally conduct test on stomach and liver tissue of SD rat, and additionally can conduct test on brain, peripheral blood and whole tissues.
In vivo Pig-a gene mutation assay
- In vivo gene mutation assay detects mutation of Pig-a gene from X chromosome. Currently, the registration as OECD TG is under discussion, and we can conduct non-GLP test on Pig-a gene mutation assay using peripheral blood of SD Rat.