WHAT WE CAN DOIn vitro Safety testing

We offer standard OECD in vitro and ex vivo protocols to validate the security of your samples before the efficacy assays
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FAST RESPONSE AND RELIABILITYMTT Cytotoxicity: ECVAM Protocol nº17

This protocol is used to determine the viability/number of cells in culture after the application of the sample at different concentrations. The quantitative measurement is performed through the use of MTT reagent.
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The ability of cells to reduce tetrazolium salt 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT)  provides an indication of mitochondrial integrity and activity which, in turn, may be interpreted as a measure of viability and/or cell number. The assay has therefore been adapted for use with cultures of exponentially growing cells. Determination of their ability to reduce MTT to the formazan product after exposure to test compounds, compared to the untreated control, enables the relative toxicity of test chemicals to be assessed.

In Dermaclaim, we have adapted this ECVAM protocol to yield a cytotoxic potential (number), through which you can conduct screenings of different compounds at the same time and determine the cytotoxic and irritating potential of finished products and ingredients in the initial phases of product development.

TOP-QUALITY CUSTOMER ATTENTIONSkin Irritation in RHE: OECD 439

Skin irritation refers to the production of reversible damage to the skin following the application of a test chemical for up to 4 hours, as defined by the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

This OECD 439 (July, 2015) protocol may be used to determine the skin irritancy of chemicals either as a stand-alone replacement test for in vivo skin irritation testing or as a partial replacement test within a testing strategy.

It is based on the in vitro test system of reconstructed human epidermis (RhE), which closely mimics the biochemical and physiological properties of the upper parts of the human skin, i.e. the epidermis. The RhE test system uses human derived non-transformed keratinocytes as cell source to reconstruct an epidermal model with representative histology and cytoarchitecture.

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COST-EFFECTIVE TESTINGPhototoxicity NRU: OECD 432

Phototoxicity is defined as a toxic response from a substance applied to the body which is either elicited or increased (apparent at lower dose levels) after subsequent exposure to light, or that is induced by skin irradiation.
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The in vitro 3T3 NRU phototoxicity test is used to identify the phototoxic potential of a test substance induced by the excited chemical after exposure to light. The test evaluates photo-cytotoxicity by the relative reduction in viability of cells exposed to the chemical in the presence versus absence of light.

Substances identified by this test are likely to be phototoxic in vivo following systemic application and distribution to the skin, or after topical application.

LATEST LABORATORY EQUIPMENTSkin Corrosion in RHE: OECD 431

Skin corrosion refers to the production of irreversible damage to the skin manifested as visible necrosis through the epidermis and into the dermis, following the application of a test chemical.

This protocol OECD 431 provides an in vitro procedure allowing the identification of non-corrosive and corrosive substances and mixtures in accordance with UN GHS. It also allows a partial sub-categorisation of corrosives.

This test makes use of reconstructed human epidermis (RHE), obtained from human derived non-transformed epidermal keratinocytes  which closely mimics the histological, morphological, biochemical and physiological properties of the upper parts of the human skin, i.e. the epidermis.

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LATEST LABORATORY EQUIPMENTEye Irritation RHE: OECD 492

Serious eye damage refers to the production of tissue damage in the eye, or serious physical decay of vision, which is not fully reversible, occurring after exposure of the eye to a test chemical
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This protocol OECD 492 provides an in vitro procedure allowing the identification of chemicals (substances and mixtures) not requiring classification and labelling for eye irritation or serious eye damage in accordance with UN GHS.

It makes use of reconstructed human cornealike epithelium (RhCE) which closely mimics the histological, morphological, biochemical and physiological properties of the human corneal epithelium.

FULL TRANSPARENCYSkin Absorption: OECD 428

This test guideline has been designed to provide information on absorption of a test substance applied to excised skin, through the use of a Static Diffusion Cell (Franz Cell).

This guideline presents general principles for measuring dermal absorption and delivery of a test substance using excised skin. Skin from many mammalian species, including 3D reconstructed skin, humans explants, or pigskin, can be used. The permeability properties of skin are maintained after excision from the body because the principal diffusion barrier is the stratum corneum.

The test substance, which may be radiolabelled, is applied to the surface of a skin sample separating the two chambers of a diffusion cell. The chemical remains on the skin for a specified time under specified conditions, before removal by an appropriate cleansing procedure. The receptor fluid is sampled at time points throughout the experiment and analysed for the test chemical and/or metabolites using HPLC-MS/MS, ELISA, etc.


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Salamanca, et al. Franz Diffusion Cell Approach for Pre-Formulation Characterisation of Ketoprofen Semi-Solid Dosage Forms. Pharmaceutics 2018.

R&D QUALITY FOCUSED ON MARKETINGSkin Mutagenicity: Ames Test OECD 471

The bacterial reverse mutation test is commonly employed as an initial screen for genotoxic activity and, in particular, for point mutation-inducing activity. Many chemicals that are positive in this test exhibit mutagenic activity in other tests.
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The bacterial reverse mutation test uses amino-acid requiring strains of Salmonella typhimurium and Escherichia coli to detect point mutations, which involve substitution, addition or deletion of one or a few DNA base pairs. The principle of this bacterial reverse mutation test is that it detects mutations which revert mutations present in the test strains and restore the functional capability of the bacteria to synthesize an essential amino acid. The revertant bacteria are detected by their ability to grow in the absence of the amino acid required by the parent test strain.

Suspensions of bacterial cells are exposed to the test substance in the presence and in the absence of an exogenous metabolic activation system. In the plate incorporation method, these suspensions are mixed with an overlay agar and plated immediately onto minimal medium. In the preincubation method, the treatment mixture is incubated and then mixed with an overlay agar before plating onto minimal medium. For both techniques, after two or three days of incubation, revertant colonies are counted and compared to the number of spontaneous revertant colonies on solvent control plates.

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