Inter-laboratory performance of ICE histopathology scoring to identify UN GHS Category 1 surfactants and non-extreme pH detergents

Autor: Klaus Weber, Ian Taylor, Dominic Byrne, Marcel V.W. Wijnands, Menk K. Prinsen, Chantra Eskes, Caroline Bertein, Vasanthi Mowat, Erwin van Vliet, Robert Kreutzer, Martina Hermann
Rok vydání: 2021
Předmět:
Zdroj: Regulatory Toxicology and Pharmacology. 126:105044
ISSN: 0273-2300
DOI: 10.1016/j.yrtph.2021.105044
Popis: The inter-laboratory performance of Isolated Chicken Eye (ICE) histopathology scoring was assessed for predicting EU CLP/UN GHS Cat. 1 surfactants. Furthermore, the predictive capacity of ICE histopathology was evaluated for the combined dataset of surfactants and existing data for non-extreme pH (2 pH 11.5) detergents. Use of ICE histopathology led to increased sensitivity compared to the ICE test method alone for surfactants. When combined with the existing dataset of detergents, use of histopathology in addition to the standard ICE test method decreased the false negative rates from 64% (14/22) to 27% (6/22); increased accuracy from 53% (16/30) to 77% (23/30); and led to acceptable level of false positives (from 0/8 to 1/8 (12.5%). Moreover, good reproducibility of ICE histopathology predictions conducted on the same slides was found between pathologists and peer-reviewers from three independent laboratories (10/12 or 83%) and over time. Use of ICE histopathology was therefore found suitable to predict EU CLP/UN GHS Cat. 1 surfactants and non-extreme pH detergents. In addition, appropriate reproducibility of ICE histopathology was found, provided that i) an internal peer-review system was in place; ii) original slides were assessed to enable evaluation of three dimensional effects; and iii) appropriate training and proficiency appraisal were conducted.
Databáze: OpenAIRE
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