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New Guidelines for Skin Sensitization Testing
In 2021, the Organization for Economic Co-operation and Development (OECD) published new test guidelines for skin sensitization - OECD 497: Defined Approaches (DAs) on skin sensitisation. These defined approaches are based on non-animal methods and can be used to predict whether chemicals can cause allergic reactions in the skin. But what does this mean for the chemical industry?
OECD 497 Guideline for Skin Sensitization
Before the introduction of OECD 497 for skin sensitization there was uncertainty around the best testing approach to adopt. In addition, based on only in vitro methods, potency could not be determined. With OECD 497, it is now possible to not only determine skin sensitization hazard but also the potency of a chemical. This helps significantly as skin sensitization has long been a concern, with many existing testing strategies being developed for, and in partnership with, the cosmetics industry. Without the option of animal testing for cosmetics, innovative testing approaches were needed, which led to new non animal testing options now being adopted in other industries.
Skin sensitization testing under OECD 497 is applicable to the industrial chemical industry as they build their dossiers for submission in the EU to comply with REACH regulations. Charles River has been working with clients for a number of years on skin sensitization methods, partnering with organizations like the Research Institute for Fragrance Materials or BASF to develop and validate methods for their ingredients. We were also involved in the evaluation and validation of assays for the OECD 442C and OECD 497 guidelines. This expertize means they can partner with industrial chemical clients to help them choose a testing strategy that fits their needs.
Skin Sensitization Partner of Choice
Charles River understands that skin sensitization testing is not a "one size fits all" solution and the unique combination of toxicology expertize, global regulatory support services, and physical chemical skills make us the partner of choice. We have extensive experience in working with compounds and molecules that can often be challenging to dissolve.
An initial pre-assessment can be carried out to define what the ideal testing package is. Then as the testing is carried out, revisions can be made as necessary, should results from one stage of testing mean the following stages need to change. With this partnership approach, you can avoid unnecessary testing thereby avoiding unnecessary costs. And since Charles River’s portfolio includes in silico, in chemico, in vitro, and in vivo options, you won’t need to switch partners. Charles River can collaborate with you every step of the way through your testing journey, including support on data interpretation and dossier preparation for submission, where needed.