Biosafety testing

The tests we offer can be carried out according to the UNI EN ISO 10993-5 regulation on the biological evaluation of medical devices and they allow to highlight the safety and the efficacy of cosmetic products tested by validated in vitro methods  alternative to animal testing.

Our assays could be classified as biosafety testing and efficacy testing.

 

BIOSAFETY TESTING

  • Evaluation of cytotoxicity (MTT TEST)
    It ‘s a colorimetric test which allows to evaluate the percentage of viable cells and consequently the effect of the treatment with the product or raw material on the viability of the cell population. The test is based on the ability of the compound MTT (tetrazolium salt, 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) to be metabolized by the mitochondrial succinate dehydrogenase enzyme, thus constituting a good marker of the health status of the cellular and mitochondrial dehydrogenases. The reduction of MTT leads to the formation of crystals of a blue product, the formazan, insoluble in water, whose amount is proportional to the number of cells.

 

  • Evaluation of cytotoxicity (NRU)
    The Neutral Red Uptake (NRU) assay is performed in order to assess the potential of skin/eye irritation of a medical device/cosmetic product using in vitro cultures of keratinocytes/primary human fibroblasts.
    Using this test it is possible to measure the damage caused by the substance on the cell membrane of keratinocytes/fibroblasts. The cells are exposed to scalar concentrations of the product to be tested and are treated with the neutral red dye (NR), which accumulates into cytoplasmic lysosomes thanks to an active transport that requires the integrity of cell membranes. Therefore, the test is able to provide information on cell integrity and, indirectly, on cell viability providing an excellent evaluation of the cytotoxic potential of the substances analyzed.

 

  •  Assessment of the phototoxic potential
    The test allows to determine the phototoxicity induced by the combined action of a chemical and of the light. The 3T3 NRU assay is based on the absorption of the vital NRU dye within the lysosomes of still intact cells and involves the comparison with the toxicity of a chemical substance, assessed in presence and in absence of exposure to a non-cytotoxic dose of UVA/visible light.
    The 3T3 NRU assay helps to identify whether the different molecules to be tested exposed to radiation (mostly UVA) show or not cytotoxic effects on the cultured cells (permanent murine fibroblast BALB / C 3T3 cell line) and is performed according to OECD guideline 432.

 

  • Evaluation of allergenic activity
    It is a test able to evaluate, by flow cytometric analysis of membrane antigens, the pro-sensitizing potential caused by raw materials/finished products for medical and cosmetic use. , the immunological reactivity of immune cells (monocytes) exposed to contact with the substance under examination is evaluated by the analysis of the expression of co-stimulatory molecules, after having identified the non-toxic concentrations using the MTT test.