Betina J. Lew served as a roving reporter at the SOT 2013 Annual Meeting and submitted the article below.
Understanding the current global regulatory and safety requirements is an important piece of a toxicologist's responsibilities in multinational companies. The REACH (Registration, Evaluation, Authorization and Restriction of Chemical substances) is the European Union regulation on chemicals and their safe use, which came into force in 2007. One of the Continuing Education (CE) courses offered this year during the 2013 SOT Annual Meeting focused on the REACH regulation and Safety Assessment Approaches for Chemicals That Come in Contact with the Skin.
Jens Thing Mortensen, of CiToxLAB Scantox, Denmark, chaired the CE course and opened the session with a great overview of the regulations. He explained that the regulation will be enforced gradually (until 2018) and that 30,000–40,000 new and existing chemicals will need to be (re)classified and (re)registered under REACH.
The skin is an important route of exposure and target organ for those chemicals, and one of the objectives of the course was to demonstrate how skin effects such as irritation corrosion, sensitization, and dermal penetration of chemicals are currently evaluated and the requirements for compliance with REACH regulations. Laura Rossi, from the European Chemicals Agency, talked about the regulations in general. Dr. Rossi addressed registration, data sharing, evaluation, authorization, and restrictions. She presented a case study in which the risk characterization was refined by exposure assessment and dermal penetration.
Hans Raabe, from the Institute for In Vitro Sciences, talked about in vitro alternatives for irritation/corrosion methods, followed by David J. Esdaile, of CiToxLab, Hungary, who discussed read across, (Q)SAR, and in vitro methods to address skin sensitization. Jon Heylings, of Dermal Technology Laboratory Ltd., closed the session by giving examples of alternative methods to measure dermal penetration.
The course provided great perspective on how alternative, non-animal methods can be used for the safety evaluation of ingredients and also presented efforts ongoing to develop new methods and the validation status of alternative state-of-the art investigational methods within dermal toxicity.