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R. Curren, J. Southee, H. Spielmann, M. Liebsch, J. Fentem, M. Balls (1995)
The Role of Prevalidation in the Development, Validation and Acceptance of Alternative MethodsAlternatives to Laboratory Animals, 23
(1994)
In vitro photo - toxicity testing . The report and recommendations of ECVAM workshop 2
M. Balls (1998)
Statement on the scientific validity of the 3T3 NRU PT test (an in vitro test for phototoxic potential), 26
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
M. Liebsch, D. Traue, C. Barrabas, H. Spielmann, P. Uphill, Susan Wilkins, J. McPherson, C. Wiemann, T. Kaufmann, Martina Remmele, Hermann-Georg Holzhütter (2000)
The ECVAM Prevalidation Study on the Use of EpiDerm for Skin Corrosivity TestingAlternatives to Laboratory Animals, 28
H. Spielmann, W. Lovell, E. Hölzle, B. Johnson, T. Maurer, M. Miranda, W. Pape, O. Sapora, D. Šladowski (1994)
In Vitro Phototoxicity TestingAlternatives to Laboratory Animals, 22
(2001)
Statement on the application of the EpiDerm TM human skin model for skin corrosivity testing
Horst Spielmann, M. Balls, M. Brand, B. Döring, Hermann-Georg Holzhütter, S. Kalweit, G. Klecak, H. Eplattenier, M. Liebsch, W. Lovell, T. Maurer, F. Moldenhauer, Lynda Moore, W.J.W. Pape, U. Pfanenbecker, J. Potthast, O. Silva, W. Steiling, A. Willshaw (1994)
EEC/COLIPA project on in vitro phototoxicity testing: First results obtained with a Balb/c 3T3 cell phototoxicity assay.Toxicology in vitro : an international journal published in association with BIBRA, 8 4
H. Spielmann, M. Balls, M. Balls, J. Dupuis, J. Dupuis, W. Pape, W. Pape, W. Pape, G. Pechovitch, G. Pechovitch, O. Silva, O. Silva, O. Silva, H. Holzhütter, H. Holzhütter, H. Holzhütter, R. Clothier, R. Clothier, R. Clothier, P. Desolle, P. Desolle, P. Desolle, F. Gerberick, F. Gerberick, F. Gerberick, M. Liebsch, M. Liebsch, W. Lovell, W. Lovell, T. Maurer, T. Maurer, T. Maurer, U. Pfannenbecker, U. Pfannenbecker, U. Pfannenbecker, J. Potthast, J. Potthast, J. Potthast, M. Csató, M. Csató, M. Csató, D. Šladowski, D. Šladowski, W. Steiling, W. Steiling, W. Steiling, P. Brantom, P. Brantom (1998)
The International EU/COLIPA In Vitro Phototoxicity Validation Study: Results of Phase II (Blind Trial). Part 1: The 3T3 NRU Phototoxicity Test.Toxicology in vitro : an international journal published in association with BIBRA, 12 3
H. Spielmann, E. Genschow, G. Scholz, N. Brown, A. Piersma, M. Brady, N. Clemann, H. Huuskonen, F. Paillard, S. Bremer, K. Becker (2001)
Preliminary Results of the ECVAM Validation Study on Three In Vitro Embryotoxicity TestsAlternatives to Laboratory Animals, 29
H. Spielmann, M. Balls, J. Dupuis, W. Pape, O. Silva, Hermann-Georg Holzhütter, F. Gerberick, M. Liebsch, W. Lovell, U. Pfannenbecker (1998)
A Study on UV Filter Chemicals from Annex VII of European Union Directive 76/768/EEC, in the In Vitro 3T3 NRU Phototoxicity TestAlternatives to Laboratory Animals, 26
(1990)
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M. Balls, P. Botham, L. Bruner, H. Spielmann (1995)
The EC/HO international validation study on alternatives to the draize eye irritation test.Toxicology in vitro : an international journal published in association with BIBRA, 9 6
The Three Rs concept, which was developed by Russell & Burch in 1959, was implemented into the legal framework in the European Union (EU) for the protection of vertebrate animals used for experimental and other scientific purposes, when Directive 86/609/EEC was adopted in 1986. One focus of activity under this Directive is the use of animals and alternative methods in regulatory testing. To reduce or replace animal testing for regulatory purposes, non-animal tests must be independently validated to prove that they can provide information that is relevant and reliable for hazard prediction in relation to specific types of toxicity in vivo. At the end of the 1980s, no scientific concept existed for the formal validation of in vitro toxicity tests, so a small group of European and American scientists met to develop a set of principles for experimental validation, which were first adopted by ECVAM in Europe in 1995, and, after harmonisation with experts from the USA and Japan, accepted internationally by the OECD in 1996. ECVAM has directly funded a number of validation studies, and a major breakthrough in the year 2000 was the acceptance for regulatory purposes in the EU of scientifically validated in vitro toxicity tests for phototoxic potential and for skin corrosivity. These, and other examples which are discussed, confirm that the internationally harmonised ECVAM/ICCVAM/OECD validation concept is a practical and effective way of making possible the replacement of regulatory testing in animals.
Alternatives to Laboratory Animals – SAGE
Published: Nov 1, 2001
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