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Primary Tests

These are the most rapid and economical and include:

Cytotoxic testing includes the placement of a dental material directly on to the tissue culture cells. The cells react metabolically depending upon the components that leach from these dental materials. The toxic response can be quantified by measurement of some biologic function such as DNA synthesis, protein synthesis, or the concentration of components that cause a decrease in cellular activity by 50% i.e. TC 50 concentration. TC 50 concentration is inversely proportional to the potency of the cytotoxic
response i.e., lower the TC 50 concentration higher is the potency. These tests do not measure whether materials biodegrade over long periods of time as a result of the physical and chemical environment.

Genotoxicity tests mammalian or non-mammalian cells, bacteria, yeasts or fungi are used to determine specifically whether gene mutations, changes in chromosome structure, or other DNA or genetic changes are caused by the test materials, devices and extracts from materials, their extract and other devices, if any.

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