Determination of skin sensitization potential is a critical toxicological endpoint in the safety assessment of novel chemicals. Although the Guinea Pig Maximization Test (GPMT) and in vivo Local Lymph node assay (LLNA) have traditionally been used to assess skin sensitization, recent activity has focused on the development of novel alternative assays for the endpoint.
As a culmination of these efforts, the Organization for Economic Cooperation and Development (OECD) published the following test guidelines for non-animal skin sensitization testing on 5 February 2015: ARE-Nrf2 Luciferase Test Method (also referred to as the KeratinoSensTM Assay (OECD TG 442D) and Direct Peptide Reactivity Assay (DPRA) (OECD TG 442C). IIVS offers these two OECD-approved methods for non-animal skin sensitization testing, the KeratinoSensTM and DPRA methods, as part of our in vitro and in chemico laboratory testing services.
Given the complex cascade of events leading to skin sensitization, it is generally thought that an integrated testing approach combining multiple assays and in silicopredictive tools will be needed to fully replace the animal based methods. There is a significant effort underway to ascertain how the non-animal assays may be combined to both qualitatively and quantitatively assess skin sensitization most effectively.
Additionally, we are in the process of transferring the h-CLAT (human Cell Line Activation Test) to our lab and plan to offer the test as a commercial service in 2016. We have participated in the validation of the LuSens assay and the KeratinoSens™ assay, which are ARE-reporter gene assays.
Please contact us for information on these skin sensitization assays and how they may be used as part of an integrated testing strategy within your existing testing program.