Table 6.
In vitro and in vivo genetic toxicity assays that optimize the standard battery for genetic toxicology recommended by the International Conference on Harmonisation
| Test name ∗ | No./Chapter No. |
|||
|---|---|---|---|---|
| OECD | EPA-OCSP | FDA Redbook 2000 | ||
| In vitro | Bacterial reverse mutation test (Ames test) | 471 | 870.5100 | IV.C.1.a. |
| In vitro mammalian chromosome aberration assay | 473 | 870.5375 | IV.C.1.b. | |
| In vitro mammalian cell micronucleus test | 487 | None | None | |
| In vitro mammalian cell gene mutation test | 476 | 870.5300 | IV.C.1.c. (only MLA) | |
| In vivo | Mammalian micronucleus test | 474 | 870.5395 | IV.C.1.d. (only erythrocyte) |
| Mammalian bone marrow chromosome aberration test | 475 | 870.5385 | None | |
| Unscheduled DNA synthesis (UDS) test with mammalian liver cells in vivo | 486 | None | None | |
| Transgenic mouse mutation assay | 488 | None | None | |
| In vivo comet assay | None | None | None | |
| Alkaline elution assay | None | None | None | |
| In vivo DNA covalent binding assay | None | None | None | |
EPA, Environmental Protection Agency; FDA, Food and Drug Administration; MLA, methyllycaconitine; OCSP, the Office of Chemical Safety and Pollution Prevention; OECD, Organisation for Economic Co-operation and Development.
Note. From R.D. Harbison, M.M. Bourgeois, and G.T. Johnson, Hamilton and Hardy's Industrial Toxicology, 6th ed, p. 1183. Copyright 2015, Hoboken (NJ): John Wiley & Sons, Inc. Adapted with permission.
∗
The recommended International Conference on Harmonisation standard test battery.