Leon H Bruner

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This is the final report of the Management Team for a European Commission/British Home Office (EC/HO) validation study on alternatives to the Draize eye irritation test. The principal goal of the study was to establish whether one or more of nine non-animal tests could be used to replace the Draize test for all severely irritating materials (or those(More)
The principal goal of this study was to determine whether the results from a set of selected currently available alternative methods as used by cosmetics companies are valid for predicting the eye irritation potential of cosmetics formulations and ingredients and, as a consequence, could be valid replacements for the Draize eye irritation test. For the(More)
Many studies have been conducted in order to assess the validity of alternative methods as replacements forin vivo toxicity tests. The purpose of this review is to build on what has been learned in the course of this work by presenting a practical process that can be used to conduct future validation programmes. The important role of a clearly stated(More)
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(More)
An area that requires further research is how best to measure test method performance in validation studies and how to set criteria that should be used to judge the adequacy of this performance. The studies reported here were designed to begin an investigation of these questions. Computer simulations were used to generate data sets similar to those that(More)
Often, the only measures of toxicity test performance provided in validation studies are the contingent probability statistics (CPS) sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). Sensitivity and specificity are generally used in preference to NPV and PPV since NPV and PPV are assumed to vary with changes in(More)
This paper represents a summary of presentations made during a round-table discussion at the ECVAM Opening Symposium. After introductory comments on the cosmetic industry's use of alternative methods in the safety assessment process, the use of alternative methods by L'Oréal and by the Japanese cosmetic industry is outlined, current validation studies in(More)
Although the Draize eye irritation test has provided important and useful information for eye safety assessments, considerable effort has been directed toward refining the assay procedure, reducing the number of animals used, and replacing this assay with alternative methods. The low-volume eye test (LVET) is a refinement of the Draize eye irritation test(More)
Government mandates are requiring serious consideration of alternatives to animal testing. For eye irritation testing, many non-whole animal alternatives exist that now need to be assessed as to their validity in replacing the animal model. The best promise for identifying useful alternatives comes from using both statistical and biological factors to(More)