In Vitro Dermal Toxicity Testing
Irritation and corrosion testing uses 3D human skin models (EpiDerm™ and EpiSkin®). In addition, an in chemico assay, Corrositex®, can be used to assign skin corrosion classifications. In silico models are also used to identify skin corrosion, irritation or sensitization potential.
Skin sensitization is a hypersensitivity reaction resulting from the interaction of a sensitizing agent with host proteins to form an immunogenic complex. Examples of sensitizers include para-phenylenediamine (PPD) in hair dyes and nickel in clothes or jewelry. When these small molecules (haptens) bind to proteins, they become immunogenic and activate the immune system, which causes localized inflammation at the site of sensitizing agent exposure.
Does the implementation of a non-animal testing strategy for skin sensitization reduce the need for animal-based test results?
Just how applicable are the alternative testing methods for the typical range of substances submitted for registration under REACH? Read our recent paper, REACH alternative testing strategy for skin sensitization in practice: Fact or fiction?
While regulatory acceptance of in vitro alternatives in a tiered approach continues to grow, in vitro skin assays are also a valuable tool for screening ahead of in vivo testing.
In our blog post, Skin Sensitization Tests: Doing More with Less, the head of our Flexible Innovation Team discusses the shift we are seeing with the industry.
Read the Blog
As part of our integrated toxicology testing strategy, there may be cases where the in vivo test should be performed rather than the in vitro test. For example, the in vivo test should be used when a classification cannot be assigned or where a regulatory authority specifically requires in vivo data. In European labs, in vitro skin assays and data collection must be performed prior to evaluating the need for or performing in vivo testing.
Scientific Publications
- In vitro Percutaneous Absorption and Metabolism of Bisphenol A (BPA) Through Fresh Human Skin
- Application of In Vitro Skin Penetration Measurements to Confirm and Refine the Quantitative Skin Sensitization Risk Assessment of Methylisothiazolinone
In Vitro Skin Assays
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SKIN SENSITIZATION ASSAYS
- DPRA (direct peptide reactivity assay)
- KeratinoSens and LuSens
- MUSST
- In silico (QSAR)
- LLNA (local lymph node assay)
- GPMT (guinea pig maximization test)
- Buehler assay (contact sensitization)
- DTH (delayed-type hypersensitization)
- GARDskin® genome test
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SKIN IRRITATION ASSAYS
- SkinEthic EpiSkin® skin irritation (OECD 439)
- Dermal acute nonrodent
- Acute dermal rodent
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SKIN CORROSION ASSAYS
- SkinEthic EpiSkin® skin corrosion (OECD 431)
- Corrositex® skin corrosion (OECD 435)
- Acute dermal rodent
Frequently Asked Questions (FAQ) for In Vitro Skin Assays
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Is there a robust and accurate way of predicting the ability of chemicals to induce sensitization in vitro?
Through a collaboration with SenzaGen, we can perform the GARDskin genome test as an in vitro alternative to the traditional animal testing methods.
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What are 3D human skin models?
3D human skin models are constructs of primary cells cultivated in a laboratory environment to form human dermal tissue. These models can then be used to perform in vitro studies of skin irritation, skin sensitization and skin corrosion, which were traditionally conducted in vivo.