title: Eye Irritation Testing: The Way Forward. The Report and Recommendations of ECVAM Workshop 34.
abstract: This is the report of the thirty-fourth of a series of workshops organised by the European Centre for the Validation of Alternative Methods (ECVAM). ECVAM's main goal, as defined in 1993 by its Scientific Advisory Committee, is to promote the scientific and regulatory acceptance of alternative methods which are of importance to the biosciences and which reduce, refine or replace the use of laboratory animals. One of the first priorities set by ECVAM was the implementation of procedures which would enable it to become well-informed about the state-of-the-art of non-animal test development and validation, and the potential for the possible incorporation of alternative tests into regulatory procedures. It was decided that this would be best achieved by the organisation of ECVAM workshops on specific topics, at which small groups of invited experts would review the current status of various types of in vitro tests and their potential uses, and make recommendations about the best ways forward (1). The workshop on Eye Irritation Testing: The Way Forward was held in Egham, UK, on 15-17 June 1998, under the chairmanship of Michael Balls (ECVAM, Italy). The workshop had two aims, the first of which was to review some of the previous multi-laboratory validation studies on alternatives to the Draize eye test and assess why many promising alternative methods were not successful in these studies. The second aim was to discuss strategies for making progress toward the short-term reduction, refinement, and eventual replacement, of the Draize test, including: a new approach to the validation of in vitro tests for eye irritancy, based on the use of reference standards, which promises to overcome some of the problems encountered in previous studies; the use of stepwise testing strategies which reduce and refine the use of animals in eye irritation testing; the use of multivariate and other statistical techniques for the further analysis of data generated in previous validation studies; and a programme of research aimed at understanding the underlying mechanisms of eye irritation.
authors.affiliation: ECVAM, JRC Environment Institute, 21020 Ispra, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Balls
authors.affiliation: Novo Nordisk, Novo Alle, 2880 Bagsvaerd, Denmark.
authors.forename: N
authors.initials: N
authors.lastname: Berg
authors.affiliation: Procter & Gamble (Health and Beauty Care), Lovett House, Lovett Road, Staines, Middlesex TW18 3AZ, UK.
authors.forename: L H
authors.initials: LH
authors.lastname: Bruner
authors.affiliation: Institute for In Vitro Sciences, 21 Firstfield Road, Gaithersburg, MD 20878, USA.
authors.forename: R D
authors.initials: RD
authors.lastname: Curren
authors.affiliation: L'Oréal Recherche Avancée - Sciences du Vivant, 1 Avenue Eugène Schueller, 93601 Aulnay-sous-Bois Cedex, France.
authors.forename: O
authors.initials: O
authors.lastname: de Silva
authors.affiliation: SEAC Toxicology Unit, Unilever Research, Colworth House, Sharnbrook, Bedford MK44 1LQ, UK.
authors.forename: L K
authors.initials: LK
authors.lastname: Earl
authors.affiliation: Rhône-Poulenc, 355 rue Dostoievski, 06903 Sophia Antipolis Cedex, France.
authors.forename: D J
authors.initials: DJ
authors.lastname: Esdaile
authors.affiliation: ECVAM, JRC Environment Institute, 21020 Ispra, Italy.
authors.forename: J H
authors.initials: JH
authors.lastname: Fentem
authors.affiliation: ZEBET, BgVV, Diedersdorfer Weg 1, 12277 Berlin, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Liebsch
authors.affiliation: Division of Pharmacology, Biological Safety Research Centre, National Institute of Health Sciences, 1-18-1 Kamiyoga, Setakaya-ku, Tokyo 158, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Ohno
authors.affiliation: TNO Nutrition and Food Research Institute, Division of Toxicology, 3700 AJ Zeist, The Netherlands.
authors.forename: M K
authors.initials: MK
authors.lastname: Prinsen
authors.affiliation: ZEBET, BgVV, Diedersdorfer Weg 1, 12277 Berlin, Germany.
authors.forename: H
authors.initials: H
authors.lastname: Spielmann
authors.affiliation: ECVAM, JRC Environment Institute, 21020 Ispra, Italy.
authors.forename: A P
authors.initials: AP
authors.lastname: Worth