Lacking applicability of in vitro eye irritation methods to identify seriously eye irritating agrochemical formulations: Results of bovine cornea opacity and permeability assay, isolated chicken eye test and the EpiOcular™ ET-50 method to classify according to UN GHS
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TLDR
A lack of applicability of the three in vitro methods to reliably predict UN GHS Cat 1 of agrochemical formulations means testing protocols and/or prediction models need to be modified or classification rules should be tailored to in vitro testing rather than using in vivo Draize data as a standard.About:
This article is published in Regulatory Toxicology and Pharmacology.The article was published on 2017-04-01 and is currently open access. It has received 15 citations till now.read more
Citations
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Journal ArticleDOI
Workshop on acceleration of the validation and regulatory acceptance of alternative methods and implementation of testing strategies.
Aldert H. Piersma,T. Burgdorf,Kimmo Louekari,Bertrand Desprez,R. Taalman,Robert Landsiedel,João Barroso,Vera Rogiers,Chantra Eskes,M. Oelgeschläger,Maurice Whelan,Albert Braeuning,Anne Marie Vinggaard,Anne S. Kienhuis,J. van Benthem,Janine Ezendam +15 more
TL;DR: This report describes the proceedings of the BfR-RIVM workshop on validation of alternative methods which was held 23 and 24 March 2017 in Berlin, Germany and describes the integrated and defined approaches are emerging at OECD.
Journal ArticleDOI
A framework for establishing scientific confidence in new approach methodologies
Anna J van der Zalm,João Barroso,Patience Browne,Warren Casey,John Gordon,Tala R. Henry,Nicole Kleinstreuer,Anna Lowit,Monique M. Perron,Amy J. Clippinger +9 more
TL;DR: In this article , the authors proposed a framework comprising five essential elements to establish scientific confidence in NAMs for regulatory use: fitness for purpose, human biological relevance, technical characterization, data integrity and transparency, and independent review.
Journal ArticleDOI
A retrospective analysis of in vivo eye irritation, skin irritation and skin sensitisation studies with agrochemical formulations: Setting the scene for development of alternative strategies.
TL;DR: A retrospective analysis of existing results from in vivo skin irritation, eye irritation, and skin sensitisation studies on a database of 223 agrochemical formulations suggests low prevalence of skin and eye irritants, suggesting bottom‐up approaches.
Journal ArticleDOI
CON4EI: CONsortium for in vitro Eye Irritation testing strategy - EpiOcular™ time-to-toxicity (EpiOcular ET-50) protocols for hazard identification and labelling of eye irritating chemicals
Helena Kandarova,Silvia Letasiova,Els Adriaens,Robert Guest,Jamin A. Willoughby,Agnieszka Drzewiecka,K. Gruszka,Nathalie Alépée,Sandra Verstraelen,An R. Van Rompay +9 more
TL;DR: In order to achieve optimal prediction for all three classes, a testing strategy was developed which combines the most predictive time-points of both protocols and for tests liquids and solids separately and the very high specificity of 97% was maintained.
Journal ArticleDOI
Human-relevant approaches to assess eye corrosion/irritation potential of agrochemical formulations
Amy J. Clippinger,Hans Raabe,David G. Allen,Neepa Choksi,Anna J. van der Zalm,Nicole Kleinstreuer,João Barroso,Anna Lowit +7 more
TL;DR: There are multiple in-vitro and ex vivo eye irritation and corrosion test methods that are available as internationally harmonized test guidelines for regulatory use as mentioned in this paper, however, despite their demonstrated use, they are not widely used.
References
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Journal Article
Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes
Book ChapterDOI
OECD guidelines for testing of chemicals
TL;DR: This updated Test Guideline 430 provides an in vitro procedure allowing the identification of non-corrosive and corrosive substances and mixtures in accordance with UN GHS.
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