Summary and Validation of New Animal-Free Toxicity Tests

Abstract

Alternatives to animal testing have been developed mainly in the fields of toxicology and vaccine testing. Typical examples are the evaluation of phototoxicity, eye irritation, or skin corrosion resulting from cosmetics and industrial chemicals. Examples also can be found in other biomedical areas, however, including the control of the quality of drug preparations or for the control of the production process of biologics. For regulatory purposes, the quality, transferability, and predictivity of an alternative method need to be evaluated. This procedure often is called the “validation process” of a new method. It follows defined rules, and several governmental institutions have been established to perform, supervise, or advise on this process. As this often results in a delay of method implementation, different alternatives for the evaluation of a method’s suitability and quality are subject to discussion. We describe here the principles of model development and quality control. We also give an overview of methods that have undergone validation. Strengths and shortcomings of traditional approaches are discussed, and new developments and challenges are outlined.