1. Reflections on the OECD guidelines for in vitro skin absorption studies
- Author
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F. Marquet, F. Larese Filon, Gunnar Johanson, Nancy B. Hopf, L. Chedik, J.L. Du Plessis, Sharyn Gaskin, Annette L. Bunge, Gerald B. Kasting, Anja Franken, Aurélie Berthet, F. Frasch, S. Kilo, Linda Schenk, C. Champmartin, Elena Reale, Klara Midander, Anneli Julander, Hopf, N. B., Champmartin, C., Schenk, L., Berthet, A., Chedik, L., Du Plessis, J. L., Franken, A., Frasch, F., Gaskin, S., Johanson, G., Julander, A., Kasting, G., Kilo, S., Larese Filon, F., Marquet, F., Midander, K., Reale, E., Bunge, A. L., 10101268 - Du Plessis, Johannes Lodewykus, and 12776998 - Franken, Anja
- Subjects
medicine.medical_specialty ,Diffusion cell ,Skin Absorption ,Time lag ,Percutaneous permeation ,Skin permeability ,010501 environmental sciences ,Toxicology ,030226 pharmacology & pharmacy ,01 natural sciences ,Hazardous Substances ,Chemical skin absorption ,In vitro skin permeation tests ,OECD guideline 428 ,Skin absorption ,Skin permeation ,Skin permeation coefficient ,03 medical and health sciences ,0302 clinical medicine ,Occupational Exposure ,Humans ,Medicine ,Medical physics ,Organisation for Economic Co-Operation and Development ,0105 earth and related environmental sciences ,Research evidence ,In vitro skin permeation test ,integumentary system ,business.industry ,Guidance documents ,Environmental Exposure ,General Medicine ,Environmental exposure ,Congresses as Topic ,Guideline Adherence ,business ,Ireland - Abstract
At the 8th conference of Occupational and Environmental Exposure of the Skin to Chemicals (OEESC) (16–18 September 2019) in Dublin, Ireland, several researchers performing skin permeation assays convened to discuss in vitro skin permeability experiments. We, along with other colleagues, all of us hands-on skin permeation researchers, present here the results from our discussions on the available OECD guidelines. The discussions were especially focused on three OECD skin absorption documents, including a recent revision of one: i) OECD Guidance Document 28 (GD28) for the conduct of skin absorption studies (OECD, 2004), ii) Test Guideline 428 (TGD428) for measuring skin absorption of chemical in vitro (OECD, 2004), and iii) OECD Guidance Notes 156 (GN156) on dermal absorption issued in 2011 (OECD, 2011). GN156 (OECD, 2019) is currently under review but not finalized. A mutual concern was that these guidance documents do not comprehensively address methodological issues or the performance of the test, which might be partially due to the years needed to finalize and update OECD documents with new skin research evidence. Here, we summarize the numerous factors that can influence skin permeation and its measurement, and where guidance on several of these are omitted and often not discussed in published articles. We propose several improvements of these guidelines, which would contribute in harmonizing future in vitro skin permeation experiments.
- Published
- 2020
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