Use of human predictive patch test (HPPT) data for the classification of skin sensitization hazard and potency.

Autor: Herzler M; German Federal Institute for Risk Assessment (BfR), Berlin, Germany. matthias.herzler@bfr.bund.de., Abedini J; Inotiv, Inc., Morrisville, NC, USA., Allen DG; Inotiv, Inc., Morrisville, NC, USA., Germolec D; Systems Toxicology Branch, Division of Translational Toxicology, National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), Research Triangle Park, NC, USA., Gordon J; United States Consumer Product Safety Commission, Rockville, MD, USA., Ko HS; United States Food and Drug Administration, Silver Spring, MD, USA., Matheson J; United States Consumer Product Safety Commission, Rockville, MD, USA., Reinke E; Inotiv, Inc., Morrisville, NC, USA., Strickland J; Inotiv, Inc., Morrisville, NC, USA., Thierse HJ; German Federal Institute for Risk Assessment (BfR), Berlin, Germany., To K; Inotiv, Inc., Morrisville, NC, USA., Truax J; Inotiv, Inc., Morrisville, NC, USA., Vanselow JT; German Federal Institute for Risk Assessment (BfR), Berlin, Germany., Kleinstreuer N; National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), Predictive Toxicology Branch, Division of Translational Toxicology, NIEHS/NIH, Research Triangle Park, NC, USA.
Jazyk: angličtina
Zdroj: Archives of toxicology [Arch Toxicol] 2024 May; Vol. 98 (5), pp. 1253-1269. Date of Electronic Publication: 2024 Mar 14.
DOI: 10.1007/s00204-023-03656-4
Abstrakt: Since the 1940s, patch tests in healthy volunteers (Human Predictive Patch Tests, HPPTs) have been used to identify chemicals that cause skin sensitization in humans. Recently, we reported the results of a major curation effort to support the development of OECD Guideline 497 on Defined Approaches (DAs) for skin sensitization (OECD in Guideline No. 497: Defined Approaches on Skin Sensitisation, 2021a. https://doi.org/10.1787/b92879a4-en ). In the course of this work, we compiled and published a database of 2277 HPPT results for 1366 unique test substances (Strickland et al. in Arch Toxicol 97:2825-2837, 2023. https://doi.org/10.1007/s00204-023-03530-3 ). Here we report a detailed analysis of the value of HPPT data for classification of chemicals as skin sensitizers under the United Nations' Globally Harmonized System of Classification and Labelling of Chemicals (GHS). As a result, we propose the dose per skin area (DSA) used for classification by the GHS to be replaced by or complemented with a dose descriptor that may better reflect sensitization incidence [e.g., the DSA causing induction of sensitization in one individual (DSA1+) or the DSA leading to an incidence of induction in 5% of the tested individuals (DSA05)]. We also propose standardized concepts and workflows for assessing individual HPPT results, for integrating multiple HPPT results and for using them in concert with Local Lymph Node Assay (LLNA) data in a weight of evidence (WoE) assessment. Overall, our findings show that HPPT results are often not sufficient for deriving unambiguous classifications on their own. However, where they are, the resulting classifications are reliable and reproducible and can be integrated well with those from other skin sensitization data, such as the LLNA.
(© 2024. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)
Databáze: MEDLINE
Externí odkaz: