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General Toxicity Assays: Teratogenicity Assays
Teratotox Assay
In order to understand the potential of a drug to induce birth defects in offspring, teratogenic studies must be performed. Reproductive toxicity is a major concern and different guidelines, such as the ICH S5(R3), state the need to assess chemicals safety during the Drug Discovery and Development Process or before drug commercialization.
Zebrafish embryos strain expressing a green fluorescent protein in the heart are used in this assay. Embryos at 2-4 hpf are treated with the test item and 5 concentrations are assayed per compound.
Embryos are analyzed at 2 and 4 dpf (days post fertilization) under the stereoscope and the minimum concentration at which lethality is induced is calculated.
Different organs and processes are analyzed under a dissecting stereoscope, including teratogenic and toxic endpoints. EC50, LC50, Teratogenic Index (TI) (ratio between LC50 and EC50) and NOAEL (Non observable adverse effect level) values are also calculated.
Further bioavailability analysis can also be performed using HPLC or MS/MS.
