First Alternative Method Validated by a Retrospective Weight-of-Evidence Approach to Replace the Draize Eye Test for the Identification of Non-Irritant Substances for a Defined Applicability Domain

Knowledge Source Identification
Knowledge source name First Alternative Method Validated by a Retrospective Weight-of-Evidence Approach to Replace the Draize Eye Test for the Identification of Non-Irritant Substances for a Defined Applicability Domain
Owner/Developer Alternatives to Animal Experimentation
Abbreviated owner ALTEX
Country Switzerland
Languages English
URL http://www.altex.ch/resources/Altex_1_10_Hartung.PDF
Description A replacement alternative to the rabbit eye irritation test has been sought for many years. First published in 1944 by FDA toxicologist J. H. Draize, the test, now known as the Draize Eye Test, has been used extensively to assess eye safety. It has also been a focal point for concern regarding its animal use. In 1992, Molecular Devices developed the Cytosensor Microphysiometer (CM) technology, an automated potentiometric online measurement of pH changes in cells, and evaluated it also for chemically induced irritation. The method was included in some of the six major validation studies for eye irritation from 1991-1997. The results for CM were inconclusive as were those from other tests evaluated as stand-alone methods to fully replace the animal test. [...] After a new, comprehensive evaluation of the prior available data, the ECVAM scientific advisory committee (ESAC) has recently accepted the CM as capable of identifying non-irritants for testing limited to water-soluble surfactants and water-soluble surfactant-containing mixtures. This 25-year development is remarkable and instructive in many respectsThe authors see this as opening the door, at last, for an end to the use of animals as a standard requirement for eye irritation. Here, several of the people critically involved in this processes have summarized the important aspects of this history.
Knowledge Source Category
Category Publication
Sub categories Report, Review / Research article
Knowledge Dissemination and Sharing
Dissemination channel Website, Printed
Targeted audience (specified/objective analysis) Scientists, Policy-makers, Regulators, Industry, Researchers, Students
Users access Open access
Knowledge Characterization
3Rs relevance Replacement
Purpose Documentation and information
Technology/Tools Alternative test methods (in vitro)