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In vitro Sensitisation / Hypersensitisation

A further step to avoid animal testing

A central claim of the authorities in the context of biological testing is to reduce, refine and replace animal testing by functional cell assays. In this context the REACH Concept, the Cosmetics Regulation, the Biocidal Products Regulation or the CLP Regulation demand to substitute in vivo animal studies by cell based in vitro test systems wherever this is possible.

As a specialized laboratory for the evaluation of medical devices, cosmetics and chemicals MicroMol already has implemented cell-based test systems for the evaluation of in vitro Cytotoxicity, Irritation to the skin and eye as well as for the determination of Skin Corrosion and Genotoxicity.

Here we announce the implementation of a novel cell-based assay for the determination of a potential allergenic reactivity of test substances, the so called Human Cell Line Activation Test (H-CLAT): The HCLAT represents a central test of the ISO 10993-10 and points out its importance especially for the cosmetic industry or in the context of Medical Device testing.

The H-CLAT defines an allergen or sensitizer by its ability to up-regulate inflammatory markers such as CD54, DC86 on the cell surface of antigen presenting cells which can be determined by Flow Cytometry in MicroMol’s section of immune analytics.

The power of this assay is further strengthened by the fact that many pharmaceutic relevant substances induce hypersensitivity reactions using the same pathway as classical sensitizers indicating that this test might get additional relevance for the pharmaceutical industry in the future.

MicroMol offers all cell-based assays ISO 17025 accredited or GMP compliant.



Dr. Wolfgang Rudy (CSO)
P +49 721 941 52 13

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