Decision trees for evaluating skin and respiratory sensitizing potential of chemicals in accordance with European regulations

Regulatory Toxicology and Pharmacology : RTP
Maryjane K SelgradeScott E Loveless

Abstract

Guidance for determining the sensitizing potential of chemicals is available in EC Regulation No. 1272/2008 Classification, Labeling, and Packaging of Substances; REACH guidance from the European Chemicals Agency; and the United Nations Globally Harmonized System (GHS). We created decision trees for evaluating potential skin and respiratory sensitizers. Our approach (1) brings all the regulatory information into one brief document, providing a step-by-step method to evaluate evidence that individual chemicals or mixtures have sensitizing potential; (2) provides an efficient, uniform approach that promotes consistency when evaluations are done by different reviewers; (3) provides a standard way to convey the rationale and information used to classify chemicals. We applied this approach to more than 50 chemicals distributed among 11 evaluators with varying expertise. Evaluators found the decision trees easy to use and recipients (product stewards) of the analyses found that the resulting documentation was consistent across users and met their regulatory needs. Our approach allows for transparency, process management (e.g., documentation, change management, version control), as well as consistency in chemical hazard assessment for...Continue Reading

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Citations

Jun 18, 2014·Regulatory Toxicology and Pharmacology : RTP·A MaierM J K Selgrade
Dec 17, 2014·Food and Chemical Toxicology : an International Journal Published for the British Industrial Biological Research Association·A M ApiD K Wilcox
Jul 12, 2016·Regulatory Toxicology and Pharmacology : RTP·Colin M NorthConnie L Chen
Oct 13, 2017·Risk Analysis : an Official Publication of the Society for Risk Analysis·Kenneth T Bogen, Michael R Garry
Oct 19, 2017·Archives of Toxicology·Aline CharyBrunhilde Blömeke
May 14, 2020·Allergy, Asthma & Immunology Research·Hung Chang TsuiJeroen A J Vanoirbeek

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