Preparation of irritant polymer samples for an in vitro round robin study.

A round robin study using reconstructed human epidermis (RhE) tissues was conducted to test medical device polymer extracts for skin irritation potential. Test samples were four irritant and three non-irritant medical device polymers. Five of these polymer samples were developed and two were obtained commercially. The three non-irritant samples were comprised of 100% 80A polyurethane, one-part silicone, and polyvinyl chloride (PVC). The polyurethane samples were made using a hot-melt process, while the silicone samples were created by mixing and casting. The PVC samples were commercially produced sheets. The four irritant samples were comprised of one-part silicone and 25% heptanoic acid (HA), two-part silicone and 15% sodium dodecyl sulfate (SDS), PVC and 4% Genapol® X-100, and PVC and 5.8% Genapol® X-080. The HA, SDS, and Genapol® X-100 samples were produced using the mixing and casting method, while the Genapol® X-080 sheet samples were obtained commercially. During development, irritant polymer samples were extracted using polar and non-polar solvents that were subsequently analyzed chemically. Samples with sufficient levels of extracted irritants were tested on RhE tissues to confirm their irritation potential. Polymers that passed this screening test were used in the round robin study described elsewhere in this special edition.