The epiderm™ skin irritation test (epiderm™ SIT)

Abstract

Assessment of the skin irritation belongs to the basic battery of toxicology tests. Due to the enormous efforts from test methods developers, validation centers and regulators, several in vitro test methods have been developed, validated and regulatory adopted as potential replacements of the rabbit skin irritation test. This chapter describes in details the skin irritation test (SIT) based on the use of the in vitro reconstructed human epidermis model EpiDerm™ (EpiDerm™ SIT). The EpiDerm™ SIT is a validated and regulatory adopted method under the OECD Test Guidelines 439 along with three other tissue models. The chapter focuses on the technical details of this assay and also provides information about the performance of this test method obtained during the validation study. Part of this chapter also describes other EpiDerm™ skin irritation protocols that can be used for the safety assessment of final cosmetic products and for testing extracts from Medical Devices in line with the ISO 10993.