As a pioneer company in preclinical safety evaluation, Creative Biolabs is capable of providing a number of early stage and late stage approaches to evaluate the skin sensitization of test articles. With years of experience, we are pleased to leverage our extensive expertise and advanced platform to tailor the best service to our clients all over the world.

What is Skin Sensitization?

Skin sensitization is defined as the allergic response to a substance which results in an inflammatory skin reaction. The typical characterization is usually presented as a red, itchy, bumpy rash. According to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS), a product or substance can be classified as a skin sensitizer following the standard below:

  • If there is evidence in humans shows that the substance can lead to sensitization by skin contact in a substantial number of persons 
  • If there are positive results from an appropriate animal test

It has been proved that more than 4,000 chemicals can lead to skin sensitization after contacting. And approximately 20% of adults in the general population is allergic to one or more skin sensitizer. Therefore, it is critical to identify the products that have the potential to cause skin sensitization in the preclinical safety evaluation.

Skin Sensitization Test Fig. 1 The symbol of skin sensitizer.

Introduction of Skin Sensitization Test

In the past years, several animal tests for the determination of skin sensitization have been established including the Mouse Local Lymph Node Assay (LLNA), the Guinea Pig Maximization Test and the Buehler Assay. However, none of these methods can provide a broad coverage of key sensitization events in the adverse outcome pathway (AOP). Therefore, there is significant interest in new approaches that will reduce the need for animal testing and provide comprehensive data for the identification of skin sensitizing chemicals. In recent years, integrated approaches that rely on assays representing key events (KEs) in the skin sensitization AOP have been accepted by OECD for hazard identification and thus classification and labeling of chemicals.

Skin Sensitization Test Provided by Creative Biolabs

With abundant experience and advanced technology, Creative Biolabs can offer several approaches for in vitro skin sensitization testing, which including but not limited to:

  • Direct Peptide Reactivity Assay (DPRA) - an in chemico method for assessing protein activity.
  • Human Cell Line Activation Test (h-CLAT) - an in vitro method for monitoring cell surface marker (CD86 and CD54) expression in human monocytes.
  • SenCee Tox® Skin Sensitization Assay - a multi-endpoint, integrated testing method.
  • KeratinoSens™ Skin Sensitization Assay - an in vitro method for monitoring induction of genes regulated by the antioxidant response element (ARE) in human keratinocytes.

You may also be interested in other local toxicity studies:

  • Ear Irritation Test
  • Mucosa Irritation Test
  • Hemolysis Test (in vivo, in vitro)

Including skin sensitization test, we offer a comprehensive pipeline of toxicology studies to promote the IND-enabling process for our worldwide customers. If you are interested in the services we can provide, please click the links below to get more information.

Creative Biolabs will be your loyal partner at every step in the process of your new drug development. For more detailed information, please feel free to contact us or directly sent us an inquiry.

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