Cytotoxicity

This assay tests for biocompatibility. The test article is extracted with DMEM media supplemented with 5% fetal bovine serum and tested on monolayer L929 mouse fibroblast cells based on the current ISO 10993‐5 standard. This protocol is a qualitative test to determine the potential of a test article to produce cytotoxicity.

This assay tests for cytotoxicity by indirect contact. This assay is not appropriate for leachables that cannot diffuse through the agar or may react with agar. The test article is laid on an agar layer poured above a monolayer of L929 mouse fibroblast cells based on the current ISO 10993-5 standard. This protocol is a qualitative test to determine the potential of a test article to produce cytotoxicity.

The MTT assay is a colorimetric test based on mitochondrial activity. It uses a yellow tetrazolium salt (MTT: 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide) that is reduced by metabolically active cells into purple formazan crystals.

The XTT assay uses a water-soluble tetrazolium salt (XTT: 2,3-bis-(2-methoxy-4-nitro-5-sulfophenyl)-2H-tetrazolium-5-carboxanilide) that is converted by viable cells into a soluble orange dye for cytotoxicity assessment.

This assay tests for the cytotoxic potential of a test article when applied to a monolayer of epidermal keratinocytes or fibroblasts in culture.

The assay is designed to detect the phototoxicity induced by the combined action of a test article and light by using an in vitro cytotoxicity assay with the Balb/c 3T3 mouse fibroblast cell line. The test identifies aqueous-soluble compounds (or formulations) that have the potential to exhibit in vivo phototoxicity.

To determine the proliferative or cytotoxic potential of a test article when applied to epidermal keratinocytes or fibroblasts in culture. Can use MTT reduction or Neutral Red Uptake.