If you’re manufacturing ingredients that are used in toothpastes, mouthwashes or oral medicines, or manufacturing medical devices used in the mouth such as oral swabs or dental guards, we’re pleased to announce the addition of oral irritation and gingival irritation tests to our portfolio.
The tests are non-regulatory and are used to assess the potency of chemicals used in products for the mouth. The method provides results which can be compared against other products and benchmark controls. If you have a number of different formulations or products in development, they are also useful for determining a rank order of irritation potential.
The test method is based on normal, human-derived buccal cells or primary human gingival cells that have been cultured to form a highly differentiated 3D model of human oral tissue or gingival mucosa. Products (test items) are applied directly to the tissue surface, providing a good model of “real life” exposure. Cell viability is measured by enzymatic conversion of the vital dye MTT into a blue formazan salt that is quantitatively measured after extraction from the tissues. Irritation potential is calculated in terms of the “ET50” value: the time taken, in minutes, for the product to reduce the viability of the tissue model to 50%.
ET50 values are then used to assign the rank order of irritation potential for a series of products or ingredients. As well as the ET50 determination, histological changes and cytokine expression may be assessed using the system. Additionally, inflammation may be induced within the test system using pro-inflammatory cytokines to investigate the protective or anti-inflammatory actions of test items.
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You can download our test information sheets or find out pricing details here: