Round Robin Study To Evaluate The Reconstructed Human Epidermis Model As An In Vitro Skin Irritation Test For Medical Devices

Existing in vitro and in vivo tests used to assess the toxicity of chemicals can also be applied to engineered nanomaterials. However, shrinking a material to the nanoscale introduces new features that need to be taken into consideration when toxicity testing is conducted. Thus, validated toxicity tests are highly desirable. OECD recommended or scientifically validated tests may require adaptation for testing of nanomaterials. Nanoparticles as well as their aggregates/agglomerates can transfer across biological barriers and thus methods for detection and uptake must be an integral part of the testing strategy. In this chapter, an overview of in vitro and in vivo test methods for the evaluation of nanomaterial toxicity is provided and methods for assessment of cellular uptake and biodistribution are discussed. Care should be taken to the selection of in vitro endpoints to avoid interference with the assay and appropriate controls should be used.