The purpose of the in vitro chromosome aberration test is to identify agents that cause structural chromosome aberrations in cultured mammalian somatic cells. Metaphase cells are analyzed microscopically for the presence of chromosome aberrations.
| Test model | Chinese hamster ovary (CHO), human peripheral blood lymphocytes |
| Assay controls | Appropriate vehicle and positive control |
| Exposure time | Short duration: With and without metabolic Activation, 3 – 6 hrs Prolonged duration treatment: Without metabolic activation, 20 – 21 hrs |
| Test item quantity | Should not be greater than 10mM, 2 mg/mL, or 2 μL/mL |
| End point | Scoring of 300 metaphases to identify aberrations |
| Data delivery | Percent chromosomal aberrations and type of chromosomal aberrations, mitotic index |
| Timeline | 10 – 12 weeks |