Detection of skin sensitization hazards in medical device materials using a combination of three alternative in vitro testing methods.

This study attempted to detect the skin sensitization hazards of medical device materials by combining multiple in vitro alternative testing methods. Nine materials were extracted using organic solvents, and the re-dissolved solutions were evaluated using the Amino acid Derivative Reactivity Assay (ADRA), Epidermal Sensitization Assay (EpiSensA), and human Cell Line Activation test (h-CLAT). The combined results of each test were compared with those of the Guinea Pig Maximization Test (GPMT) results. The findings of ADRA and h-CLAT were consistent with the GPMT results for seven of the nine materials, and EpiSensA was consistent with the GPMT results for eight of the nine materials. The findings of the "2 out of 3" and Sequential Testing Strategy (STS) approaches were compared with the GPMT results. The GMPT results for all nine materials were correctly predicted when the "2 out of 3" approach was used. When the STS was used, it correctly predicted the GMPT results for eight of the nine materials. Therefore, integrating the ADRA, EpiSensA, and h-CLAT may provide an effective testing method for detecting skin sensitization hazards of organic solvent extracts from medical device materials.