Traditionally, tests in small animals have been performed prior to testing on humans to help predict human responses. More recently, in vitro tests as well as human tests have been added as adjuncts or alternatives. For skin irritation testing of neat chemicals, in vitro tests were developed using reconstructed human epidermis (RhE) models[31]. The method was adapted for detection of irritant chemicals in medical device extracts. The results of a large interlaboratory study that tested two types of RhE models showed that these models can also be used to detect the presence of irritant chemicals extracted from polymeric materials [polyvinylchloride (PVC) and silicone] commonly used in the manufacture of medical devices[6]. This method was found to be equally sensitive in the detection of low concentrations of some strong irritant compounds when compared to the human patch testing and intracutaneous rabbit test. Therefore, a stepwise approach for irritant testing can start with the in vitro Rhe model…
