The purpose of the OECD 473: In Vitro Mammalian Chromosomal Aberration test is to evaluate structural chromosomal aberrations in cultured mammalian cells. This study design follows the current OECD guideline Test No. 473: In Vitro Mammalian Chromosomal Aberration Test (2016) and can be performed in accordance with Good Laboratory Practices. This individual in vitro test is often coupled with an additional in vitro and in vivo genotoxicity test, in order to fulfill the FDA/ICH S2(R1) guidelines for a New Drug Submission.
Chromosomal aberrations have been the cause of many human genetic diseases, and there is substantial evidence that these chromosomal damages are associated with tumor formation in animals and humans. Therefore, the in vitro mammalian chromosomal aberration test is one of the recommended tests to determine the mutagenic potential of a substance.
The In Vitro Mammalian Chromosomal Aberration test can be performed in both established or primary cell lines, including, but not limited to, cultured Chinese Hamster Ovary cells (CHO) or human peripheral blood lymphocytes. This assay involves the exposure of the test article to the cells, either with or without metabolic activation. Cells are then treated with a metaphase-arresting chemical and analyzed microscopically to measure the frequency of chromatid-type and chromosome-type aberrations. At Nucro-Technics, these tests can be conducted with either short-term or long-term exposure, and may include a preliminary dose-range finding test and primary mutagenicity test.
Testing under OECD 473 will require 1 gram of test article. A draft report will be ready for review within 10-12 weeks after the experiment start date. Archiving of all documents will be for six years.