In Vitro Toxicity Testing; Designed to Generate Data Concerning the Adverse Effects of A Substance on Human or Animal Health, or the Environment

 

In Vitro Toxicity Testing

In vitro toxicity testing is the scientific analysis of the effects of toxic chemical substances on cultured bacteria or mammalian cells. There are various assays that are used in testing, such as ATP, MTS, MTT, Neutral Red, and Enzyme-linked Immunosorbent Assay (ELISA). The MTT assay is used to compare the viability changes in treated cells to untreated cells. The MTS assay is used to assess cell proliferation, cell viability and cytotoxicity. The ATP assay has the main advantage of providing results quickly and only requires fewer sample cells.

Toxicity assays include the assessment of whether the transplanted cell product exerts any general toxicity effects in the host that could affect organs such as the kidney, liver, heart, and brain. In vitro toxicity testing is one of the biological evaluation and screening tests that use tissue cells in vitro to observe the cell growth, reproduction, and morphological effects by medical devices. It finds application in the pharmaceuticals, household products, food and beverages, cosmetics, and chemicals sectors.

In vitro toxicity testing offers many advantages, such as the use of concentrations relative to human exposure, the ability to elucidate cellular-response networks and toxicity pathways, and enabling high-throughput studies. It is used to examine the toxic properties of compounds and mixtures on cultured bacteria or mammalian cells. The demand for in vitro toxicity testing has increased due to its various advantages. The test provides adequate detection of toxic effects on organisms at very low concentrations, which are otherwise not possible in animal testing.

Except for the genotoxicity test, there are two regulatory guidelines in Japan for in vitro toxicity studies. One of them is a cytotoxicity test for the safety evaluation of extracts from plastic devices for medical use. The other is an in vitro endotoxin test (the Limulus test). Both of them are included in the Japanese Pharmacopoeia.


Location: India

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