Summary and Validation of New Animal-Free Toxicity Tests

Validation is a normal procedure in all fields of science once a test is developed (Hartung, 2007). The validation process is intended to provide confidence in the results, to define where the test may or may not be applied, and to give an account of test characteristics such as precision, accuracy, specificity, sensitivity, robustness, and transferability. The establishment, validation, and documentation of test methods in different areas of science all have been extensively covered in the specialist literature. This includes specific recommendations published by regulatory bodies. For instance, OECD GD 34 gives guidance on “Development, Validation and Regulatory Acceptance of New and Updated Internationally Acceptable Test Methods in Hazard Assessment.” While the predictivity and biological relevance often are difficult to quantify, the quality of an assay system may be assessed by strictly quantitative methods.