The chemical industry is currently confronted with challenges as the advancement in regulations and guidelines for safety assessment of exposure to chemicals is redefined in the United States. The Frank R. Lautenberg Chemical Safety for the 21st Century Act, revises the standard under the Toxic Substances Control Act (TSCA) used to determine whether regulatory control of a certain chemical is warranted. Under section 4 (h) REDUCTION OF TESTING ON VERTEBRATES, the bill encourages and facilitates “the use of scientifically valid test methods and strategies that reduce  or  replace  the  use  of  vertebrate  animals  while  providing  information of equivalent or better scientific quality and relevance that will support regulatory decisions under this title” and “promote the  development  and  timely  incorporation  of  new  scientifically  valid  test  methods   and   strategies   that   are   not   based   on   vertebrate   animals’. As an industry we can draw upon lessons learned from EU Regulation 1223/2009, which bans animal testing of cosmetic ingredients and finished products in the EU, and also the REACH guidelines which have validated non-animal based assays as default methods for several endpoints including skin sensitization. Currently, there are three non-animal skin sensitization testing methods which have published Organisation for Economic Co-operation and Development (OECD) test guidelines, with many others in various stages of development, validation and standardization. A major area of research is how to best combine these various methods to ensure consumer and worker safety. In this presentation, I will review the Adverse Outcome Pathway (AOP) for skin sensitization and the non-animal based methodologies plus assays which model each key event of the complex cascade leading to allergic contact dermatitis, the regulatory status of these models, and approaches to combining the methods in integrated testing strategies (ITS) to improve accuracy of predictions.<br/>

<i>In vitro</i> methods available for chemical risk assessment under amended TSCA for skin sensitization evaluation

254th National Meeting (2017)

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In vitro methods available for chemical risk assessment under amended TSCA for skin sensitization evaluation