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J. Kanno, L. Onyon, S. Peddada, J. Ashby, E. Jacob, W. Owens (2003)
The OECD program to validate the rat uterotrophic bioassay. Phase 2: dose-response studies.Environmental Health Perspectives, 111
R. Combes (2000)
Endocrine Disruptors: A Critical Review of In Vitro and In Vivo Testing Strategies for Assessing Their Toxic Hazard to HumansAlternatives to Laboratory Animals, 28
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The use of prediction models in toxicology: what should they predict
J. Owens, J. Ashby (2002)
Critical Review and Evaluation of the Uterotrophic Bioassay for the Identification of Possible Estrogen Agonists and Antagonists: In Support of the Validation of the OECD Uterotrophic Protocols for the Laboratory RodentCritical Reviews in Toxicology, 32
Jun Kanno, L. Onyon, Joseph Haseman, Penelope Fenner-Crisp, John Ashby, W. Owens (2001)
The OECD program to validate the rat uterotrophic bioassay to screen compounds for in vivo estrogenic responses: phase 1.Environmental Health Perspectives, 109
J. Kanno, L. Onyon, S. Peddada, J. Ashby, E. Jacob, W. Owens (2003)
The OECD program to validate the rat uterotrophic bioassay. Phase 2: coded single-dose studies.Environmental Health Perspectives, 111
M. Festing, V. Baumans, R. Combes, M. Haider, C. Hendriksen, B. Howard, D. Lovell, Graham Moore, P. Overend, M. Wilson (1998)
Reducing the Use of Laboratory Animals in Biomedical Research: Problems and Possible SolutionsAlternatives to Laboratory Animals, 26
H. Spielmann, M. Liebsch (2001)
Lessons learned from validation of in vitro toxicity test: from failure to acceptance into regulatory practice.Toxicology in vitro : an international journal published in association with BIBRA, 15 4-5
E. Genschow, G. Scholz, N. Brown, A. Piersma, M. Brady, N. Clemann, H. Huuskonen, F. Paillard, S. Bremer, K. Becker, H. Spielmann (2000)
Development of prediction models for three in vitro embryotoxicity tests in an ECVAM validation study.In vitro & molecular toxicology, 13 1
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Alternative (nonanimal) methods for chemicals testing: current status and future prospects
LH Bruner, GJ Carr, JW Harbell, RD Curren (2002)
An investigation of new toxicity test method performance in validation studies: 2. comparison of three measures of toxicity test performanceHuman and Experimental Toxicology, 21
L. Bruner, G. Carr, J. Harbell, R. Curren (2002)
An investigation of new toxicity test method performance in validation studies: 1. toxicity test methods that have predictive capacity no greater than chanceHuman and Experimental Toxicology, 21
Leon Bruner, G. Carr, M. Chamberlain, R. Curren (1996)
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V. Baker (2001)
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Report and recommendations of the CAAT/ERGATT workshop on the validation of toxicity test procedures
W. Owens, J. Ashby, J. Odum, L. Onyon (2003)
The OECD program to validate the rat uterotrophic bioassay. Phase 2: dietary phytoestrogen analyses.Environmental Health Perspectives, 111
J. Ashby (2000)
Validation of In Vitro and In Vivo Methods for Assessing Endocrine Disrupting ChemicalsToxicologic Pathology, 28
H. Blom, G. Tintelen, C. Vorstenbosch, V. Baumans, A. Beynen (1996)
Preferences of mice and rats for types of bedding materialLaboratory Animals, 30
R. Combes, M. Balls (2003)
How Much Flexibility is Possible When Validating New In Vivo and In Vitro Toxicity Test Methods?Alternatives to Laboratory Animals, 31
Balls Michael, Blaauboer j., F. helen, Bruner Leon, C. D., E. Bjorn, Fielder Robin, Guillonzo Andre, L. Richard, Lovell David, R. Christoph, Sladowski Dariusz, S. Horst, Zucco Flavia (1995)
Practical Aspects of the Validation of Toxicity Test Procedures
H. Spielmann, M. Liebsch (2002)
Validation Successes: ChemicalsAlternatives to Laboratory Animals, 30
W. Owens, H. Koëter (2003)
The OECD program to validate the rat uterotrophic bioassay: an overview.Environmental Health Perspectives, 111
J. Ashby, W. Owens, J. Odum, H. Tinwell (2003)
The intact immature rodent uterotrophic bioassay: possible effects on assay sensitivity of vomeronasal signals from male rodents and strain differences.Environmental Health Perspectives, 111
J. Bailey, K. Nephew (2002)
Strain differences in tamoxifen sensitivity ofSprague-Dawley and Fischer 344 ratsAnti-Cancer Drugs, 13
Leon Brunei, G. Carr, M. Chamberlain, R. Curren (1996)
No Prediction Model, No Validation StudyAlternatives to Laboratory Animals, 24
H. Holzhütter, G. Archer, N. Dami, D. Lovell, Andrea Saltelli, M. Sjöström (1996)
Recommendations for the Application of Biostatistical Methods during the Development and Validation of Alternative Toxicological MethodsAlternatives to Laboratory Animals, 24
L. Edler, C. Ittrich (2003)
Biostatistical Methods for the Validation of Alternative Methods for In Vitro Toxicity TestingAlternatives to Laboratory Animals, 31
Balls Michael (1996)
The Validation of Alternative Test Methods
The design and execution of a recently completed validation study on the rat uterotrophic assay for detecting oestrogens and anti-oestrogens, managed by the OECD, are critically assessed with respect to internationally agreed criteria for the validation of new in vitro and in vivo toxicity test methods. It is concluded that, while the design of the study did not take account of several important criteria for validation, the uterotrophic assay appears to reliably detect the strong and weak oestrogenic substances used in the study, which act via binding to the oestrogen receptor in vivo. However, the reliability of the assay has not been substantiated for detecting anti-oestrogens that act as antagonists, due to the involvement of an insufficient number of experiments and test chemicals. Moreover, the data do not permit an assessment of the accuracy of the prediction of oestrogenicity, and the protocols have not been sufficiently optimised with regard to controlling variables. This problem has been exacerbated by a wish to introduce as much flexibility as possible into the protocols during the formal validation phase of the study, rather than during a separate prevalidation stage. In addition, the choice between surgically treated and/or immature animals, and details of housing and husbandry conditions that are necessary for increasing the sensitivity and efficiency of the assay, need to be clarified. The assay also lacks a well-defined prediction model by which the overall relevance of the data to toxicity, and especially to human hazard, can be assessed, and no performance criteria have been established. The results of this analysis of the study indicate that it would be premature to produce an OECD test guideline for the uterotrophic assay at this time, before some of the above issues have been satisfactorily resolved.
Alternatives to Laboratory Animals – SAGE
Published: Sep 1, 2003
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