Skin Irritation and Sensitization In Vitro Test

In vitro skin tests using human, animal, and three-dimensional (3D) tissue substitutes effectively replace the traditional acute toxicity test model. This transformation is particularly evident in skin irritation and skin sensitization models, all of which are fully supported by Creative Biolabs.

What is Skin Irritation and Sensitization?

Skin is the largest human organ, composed of multiple layers, and has many vital functions for survival. One of them is to protect the human body from environmental hazards (such as toxic or corrosive substances). Therefore, in the preclinical safety evaluation of drugs, it is very important to determine the products that may cause skin irritation and allergy.

  • Skin Irritation
  • The so-called skin irritation refers to the local toxicity caused by skin local contact with certain substances, and the damage is reversible. Many types of products can cause skin irritation through the stratum corneum, which is characterized by redness, itching, or pain in the area where the product is in contact.

  • Skin Sensitization
  • Skin sensitization refers to the allergic reaction to certain substances, which leads to skin inflammation. The typical feature is usually a red, itchy, raised rash. The substance is classified as skin sensitive if there is evidence in humans that the substance can cause allergies through skin contact, or if the appropriate animal test results are positive.

Skin Irritation and Sensitization In Vitro Test

There is a growing demand for the alternative in vitro methods to replace animal testing and to be successful, new methods are required to be at least as accurate as existing in vivo tests. At present, various cell-based methods have been developed and used for the evaluation and/or ranking of skin irritants. Cell models include monolayer culture of human and animal skin cells (keratinocytes), multi-layer (3D) culture of skin cells providing barrier function similar to the skin surface, and co-culture model of two or more cell types found in the skin.

Based on cell models, through the use of related biological systems, the high amount of information expressed in the entire genome, and comprehensive bioinformatics, the determination of the most complex biological processes can be achieved.


For a topical application or exposed live biotherapeutic products, in vitro skin test to evaluate the possibility of skin irritation and skin sensitization is a key factor in their safety assessment.

At present, we have developed several in vitro skin tests to evaluate the skin sensitization and irritation potential of live biotherapeutic products, including but not limited to:

  • Direct peptide reactivity analysis (DPRA) - a chemical method for evaluating protein activity by measuring the binding of applied products to synthetic peptides used to mimic skin proteins;
  • Human Cell Line Activation Test (h-CLAT) - an in vitro method for monitoring the expression of surface markers on human monocytes;
  • Reconstructed Human Epidermis Test (RHET) - A state-of-the-art in vitro skin irritation test (SIT) method.

Both the existing technologies and the development of new and high-throughput in vitro toxicology methods at the level of genomics and proteomics have shown good consistency with in vivo tests. At Creative Biolabs, we have a team of experts dedicated to contributing to the field of in vitro toxicology and can support the testing needs of our customers from all over the world through standard analysis and customized methods. If you have any questions about our services, please contact us for more information.

For Research Use Only. Not intended for use in food manufacturing or medical procedures (diagnostics or therapeutics). Do Not Use in Humans.

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For Research Use Only. Not intended for use in food manufacturing or medical procedures (diagnostics or therapeutics). Do Not Use in Humans.

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