Abstract
The first report of the FRAME Toxicity Committee (1) included the recommendation that more effort should be put into the development and validation of alternative techniques, but, at the time, with the notable exceptions of short-term tests for mutagenicity (2, 3) and for biologically-active mineral dusts (4), it was difficult to find any collaborative interlaboratory attempts to establish the reliability and usefulness of in vitro methods in toxicity testing (5). For this reason, FRAME established a research programme, which at that time was unique in that it involved collaboration between four laboratories in the development of a common cytotoxicity test protocol and led to a blind trial involving a relatively large number of coded chemicals (6). When other laboratories asked for access to coded chemicals, the FRAME Alternative Test Validation Scheme was established (7), and the results of a number of blind trials have since been published (e.g. 8–11).
This is a preview of subscription content, log in via an institution.
Preview
Unable to display preview. Download preview PDF.
REFERENCES
Anon (1982). Report of the FRAME Toxicity Committee, 40 pp. Nottingham: FRAME.
De Serres, F. & Ashby, J. eds (1981). Progress in Mutation Research, Vol. I, Evaluation of short-term tests for carcinogens. Amsterdam: Elsevier/North-Holland.
Purchase, I.F.H. (1982). An appraisal of predictive tests for carcinogenicity. Mutation Research 99, 53–71.
Brown, R.C., Chamberlain, M., Davies, R., Morgan, D.M.L., Pooley, F.D. & Richards, R.J. (1980). A comparison of 4 in vitro systems applied to 21 dusts. In The In Vitro Effects of Mineral Dusts (ed. R.C. Brown, LP. Gormley, M. Chamberlain & R. Davies), pp. 47–52. London: Academic Press.
Balls, M. (1983). The FRAME research programme. In Animals and Alternatives in Toxicity Testing (ed. M. Balls, R.J. Riddell & A.N. Worden), pp. 471–475. London: Academic Press.
Knox, P., Uphill, P.F., Fry, J.R., Benford, D.J. & Balls, M. (1986). The FRAME multi-centre project on in vitro cytotoxicology. Food and Chemical Toxicology 24, 457–463.
Balls, M. & Horner, S.A. (1985). The FRAME interlaboratory programme on in vitro cytotoxicology. Food and Chemical Toxicology 23, 209–213.
Stark, D.M., Shopsis, C, Borenfreund, E. & Babich, H. (1986). Progress and problems in evaluating and validating alternative assays in toxicology. Food and Chemical Toxicology 24, 449–455.
Kemp, R.B., Cross, D.M. & Meredith, R.W.J. (1986). Adenosine triphosphate as an indicator of cellular toxicity in vitro. Food & Chemical Toxicology 24, 465–466.
Riddell, R.J., Clothier, R.H. & Balls, M. (1986). An evaluation of three in vitro cytotoxicity assays. Food & Chemical Toxicology 24, 469–471.
Clothier, R.H. & Balls, M. (1990). Validation of alternative toxicity tests: principles, practices and cases. Toxicology in Vitro 4, 692–693.
Bondesson, I., Ekwall, B., Hellberg, S., Romert, L., Stenberg, K. & Walum, E. (1989). MEIC-a new international multicenter project to evaluate the relevance to human toxicity of in vitro cytotoxicity tests. Cell Biology and Toxicology 5, 331–347.
Ekwall, B., Bondesson, I., Castell, J.V., Gómez-Lechón, M.J., Hellberg, S., Högberg, J., Jover, R., Pondosa, X., Romert, L., Stenberg, K. & Walum, E. (1989). Cytotoxicity evaluation of the first ten MEIC chemicals: acute lethal toxicity in man predicted by cytotoxicity in five cellular assays and by oral LD50 tests in rodents. ATLA 17, 83–100.
Booman, K.A., Cascieri, T.M., Demutrulias, J., Driedger, A., Griffith, J.F., Grochoski, G.T., King, B., McCormick, W.C., North-Root, H., Rozen, M.G. & Sedlak, R.I. (1988). In vitro methods for estimating eye irritancy of cleaning products. Phase 1: preliminary assessment. Journal of Toxicology and Cutaneous and Ocular Toxicology 7, 173–185.
Gettings, S.D. & McEwen, G.N. (1990). Development of potential alternatives to the Draize eye test: the CTFA evaluation of alternatives program. ATLA 17, 317–324.
Kalweit, S., Besoke, R., Gerner, I. & Spielmann, H. (1990). A national validation project of alternative methods to the Draize rabbit eye test. Toxicology in Vitro 4, 702–706.
Scala, R.A. (1987). Theoretical approaches to validation. In Alternative Methods in Toxicology, Vol. 5, Approaches to Validation (ed. A.M. Goldberg), pp. 1–9. New York: Mary Ann Liebert.
Balls, M., Riddell, R.J., Horner, S.A. & Clothier, R.H. (1987). The FRAME approach to the development, validation and evaluation of in vitro methods. In Alternative Methods in Toxicology, Vol. 5, Approaches to Validation (ed. A.M. Goldberg), pp. 45–58. New York: Mary Ann Liebert.
Balls, M. & Clothier, R. (1989). Validation of alternative toxicity test systems: lessons learned and to be learned. Molecular Toxicology 1, 547–559.
Frazier, J.M. (1990). Scientific Criteria for the Validation of In Vitro Toxicity Tests. OEC Environment Monograph 36, 62 pp. Paris: OECD.
Bulling, E., Spielmann, H. & Bass, R. eds (1989). Wege zur Bewertung und Anerkennung von Alternativen zum Tierversuch. BGA Schriften 2, 1–88.
Balls, M., Blaauboer, B., Brusick, D., Frazier, J., Lamb, D., Pemberton, M., Reinhardt, C., Roberfroid, M., Rosenkranz, H., Schmid, B., Spielmann, H., Stammati, A.–L. & Walum, E. (1990). Report and recommendations of the CAAT/ERGATT workshop on the validation of toxicity test procedures. ATLA 18, 313–337.
Balls, M., Botham, P., Cordier, A., Fumero, S., Kayser, D., Koëter, H., Koundakjan, P., Gunnar Lindquist, N., Meyer, O., Pioda, L., Reinhardt, C., Rozemond, H., Smyrniotis, T., Spielmann, H., Van Looy, H., an der Venne, M.-T. & Walum, E. (1990). Report and recommendations of an international workshop on promotion of the regulatory acceptance of validated non-animal toxicity test procedures. ATLA 18, 339–344.
Purchase, I.F.H. (1990). An international reference chemical data bank would accelerate the development, validation and regulatory acceptance of alternative toxicity tests. ATLA 18, 345–348.
Warren, M., Atkinson, K. & Steer, S. (1989). Introducing INVITTOX: the ERGATT/ FRAME in vitro toxicology data bank. ATLA 16, 332–343.
Anon. (1990). The INVITTOX register of validation schemes. ATLA 18, 200.
Smyrniotis, T. (1990). Juridical criteria for the evaluation and recognition of methods to replace and supplement animal experiments in the European Community. BGA Schriften 2, 59–62.
van den Heuvel, M.J. (1990). A fixed-dose procedure as a replacement for the classical LD50 test: the UK initiative. In LD50 Testing and Classification Schemes: The Possibilities for Change, pp. 71–82. Brussels: CEC.
van den Heuvel, M.J. (1990). An alternative to the LD50? Human and Experimental Toxicology 9, 369–370.
Balls, M. (1991). The validation and acceptance of in vitro toxicity tests. In In Vitro Toxicology: An Alternative to Animal Testing? (ed. L. Valette & A. Cordier). London: Academic Press, in press.
Anon. (1986). Council Directive of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes. Official Journal of the European Communities 29 (L358), 1–29.
Zbinden, G. (1988). A look behind drug regulatory guidelines. In National and International Drug Safety Guidelines (ed. S. Adler & G. Zbinden), pp. 7–19. Zollikon: MTC Verlag.
Balls, M., Reinhardt, CA., Spielmann, H. & Walum, E. (1991). The development, validation and acceptance of in vitro toxicity tests. In Animals and Alternatives in Toxicology-Present Status and Future Prospects (ed. M. Balls, J.W. Bridges & J.A. Southee), 291–301. London: Macmillan Press and New York: VCH Publishers Inc.
Doull, J. (1984). The past, present and future of toxicology. Pharmacological Reviews 36, 155–185.
Warner, F., ed. (1986). Risk Assessment: A Study Group Report. London: Royal Society.
Aldridge, W.N. & Schlatter, C.H. (1980). Training and Education in Toxicology. Archives of Toxicology 45, 249–256.
Miya, T.S., Gibson, J.E., Hook, J.B. & McCellan, R.O. (1988). Contemporary issues in toxicology. Preparing for the twenty-first century. Report of the TOX-90’s Commission. Toxicology and Applied Pharmacology 96, 1–6.
Press, F. (1984). Keynote address. In: Symposium on Safety Assessment: The Interface Between Science, Law and Regulation. 12–14 September, 1983. Fundamental and Applied Toxicology 4 S257–S260.
Ruckelshaus, W. (1983). Science risk and public policy. Science, New York 221, 126–129.
Rodricks, J.V. (1986). Improving the use of risk assessment in regulation. Comments on Toxicology 1, 95–76.
Wilkinson, C.F. (1986). Risk assessment and regulatory policy. Comments on Toxicology 1, 1–2.
Roe, F.J.C. (1989). What is wrong with the way we test chemicals for carcinogenic activity? In Advances in Applied Toxicology (ed. A.D. Dayan & A.J. Paine), pp. 1–17. London: Taylor & Francis.
Roberfroid, M.B. (1988). Toxicologe in vitro, un défi pour le XXIème siècle, réflexions d’un fondamentaliste. In Méthodes in Vitro en Pharmaco-Toxicologie (ed. M. Adolphe & A. Guillouzo), pp. 147–158. Paris: Colloque INSERM.
Kroes, R. & Feron, V.J. (1984). General toxicity testing: sense and nonsense, science and policy. In: Symposium on Safety Assessment: The Interface Between Science, Law and Regulation, 12–14 September, 1983. Fundamental and Applied Toxicology 4, S298–S308.
Hall, R.L. (1984). What will food science require of toxicology? In: Symposium on Safety Assessment: The Interface Between Science, Law and Regulation, 12–14 September, 1983. Fundamental and Applied Toxicology 4, S278–S283.
Hicks, M. & Kroes, R. (1991). Proceedings of the Symposium Organised by ILSI Europe on Re-evaluation of Current Methodology of Toxicology Testings Including Gross Nutrients. Food and Chemical Toxicology, 28, 733–790.
Anon. (1989). LD50 Testing and Classification Schemes: The Possibilities for Change, Brussels: CEC, 107 pp.
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Copyright information
© 1991 FRAME
About this chapter
Cite this chapter
Balls, M., Reinhardt, C.A., Spielmann, H., Walum, E. (1991). The Development, Validation and Acceptance of In Vitro Toxicity Tests. In: Balls, M., Bridges, J., Southee, J. (eds) Animals and Alternatives in Toxicology. Palgrave, London. https://doi.org/10.1007/978-1-349-12667-5_11
Download citation
DOI: https://doi.org/10.1007/978-1-349-12667-5_11
Publisher Name: Palgrave, London
Print ISBN: 978-1-349-12669-9
Online ISBN: 978-1-349-12667-5
eBook Packages: EngineeringEngineering (R0)