An overall strategy for the testing of chemicals for human hazard and risk assessment under the EU REACH system

Alternatives to Laboratory Animals

Volumn 31, Issue 1, 2003, Pages 7-19

  Combes, Robert ^a   Barratt, Martin ^b   Balls, Michael ^a  

^a RUSSELL AND BURCH HOUSE   (United Kingdom)

^b Marlin Consultancy   (United Kingdom)

Author keywords

(Q)SAR and expert systems; Biokinetic modelling; Decision trees; ECVAM; EU chemicals policy; Non animal testing scheme; Read across; Risk assessment; Threshold of regulation

Indexed keywords

CHEMICAL COMPOUND;

ANIMAL TESTING ALTERNATIVE; ARTICLE; DECISION THEORY; ECONOMIC ASPECT; EUROPE; EXPERT SYSTEM; FUTUROLOGY; HAZARD; HEALTH CARE POLICY; MEDICAL DOCUMENTATION; MEDICAL ETHICS; MEDICAL EXPERT; NONHUMAN; PHYSICAL CHEMISTRY; PREDICTION; PRIORITY JOURNAL; QUANTITATIVE STRUCTURE ACTIVITY RELATION; RISK ASSESSMENT; TIME; TOXICITY TESTING; VALIDATION PROCESS;

ANIMALIA;

EID: 0037230506     PISSN: 02611929     EISSN: None     Source Type: Journal    
DOI: 10.1177/026119290303100103     Document Type: Article

References (31)

1. Anon (2001). White Paper on a Strategy for a Future Chemicals Policy (COM(2001)88 final). Web site http://europa.eu.int/comm/environment/chemicals/whitepaper.htm (Accessed 8.1.01).
2. Combes, R.D. (2002). The EU white paper: Strategy for a Future Chemicals Policy (an idea that must have seemed good at the time!). ATLA 30, 1-3.
3. Worth, A.P. & Balls, M., eds (2002). Alternative (non-animal) methods for chemicals testing: current status and future prospects. A report prepared by ECVAM and the ECVAM Working Group on Chemicals. ATLA 30, Suppl. 1, 1-125.
4. Bottrill, K, (1998). The use of biomarkers as alternatives to current animal tests on food chemicals. ATLA 26, 421-480.
5. Cramer, G.M., Ford, R.A. & Hall, R.L. (1978). Estimation of toxic hazard: a decision-tree approach. Food and Chemical Toxicology 16, 255-276.
6. Atterwill, C.K. & Wing, M.G. (2002). In vitro preclinical lead optimisation technologies (PLOTs) in pharmaceutical development. Toxicology Letters 127, 143-151.
7. Frawley, J.P. (1967). Scientific evidence and common sense as a basis for food-packaging regulations. Food and Chemical Toxicology 5, 293-308.
8. Munro, I.C., Ford, R.A., Kennepohl, E. & Spreger, J.G. (1996). Correlation of structural class with no-observed-effect levels: a proposal for establishing a threshold of concern. Food and Chemical Toxicology 34, 829-867.
9. Cheeseman, M.A., Machuga, E.J. & Bailey, A.B. (1999). A tiered approach to Threshold of Regulation. Food and Chemical Toxicology 37, 387-412.
10. Combes, R.D. (1997). Defining a "threshold of regulation" the ultimate alternative for safety assessment? ATLA 25, 187-191.
11. Kroes, R. & Kozianowski, G. (2002). Threshold of toxicological concern (TTC) in food safety assessment. Toxicology Letters 127, 43-46.
12. Hanway, R.H. & Evans, P.F. (2000). Read-across of toxicological data in the notification of new chemicals. Toxicology Letters 116, Suppl. 1, 61.
13. Barratt, M.D. (2000). Principles of toxicity prediction from structure. In Progress in Reduction, Refinement and Replacement in Animal Experimentation (ed. M. Balls, A-M. van Zeller & M.E. Halder), pp. 449-456. Amsterdam, The Netherlands: Elsevier.
14. Kayser, D. & Roll, R., eds (1995). Strategy of Toxicological Testing to Assess Chemicals within the Framework of the Chemicals Act. BgVV Schriften (published in German and English). 76 pp. Munich, Germany: MMV Medizin Verlag.
15. Combes, R.D. (1992). The in vivo relevance of in vitro genotoxicity assays incorporating enzyme activation systems. In Progress in Drug Metabolism, Vol 13 (ed. G.G. Gibson), pp. 295-321. London, UK: Taylor and Francis.
16. Coecke, S., Rogiers, V., Bayliss, M., Castell, J., Doehmer, J., Fabre, G., Fry, J., Kern, A. & Westmoreland, C. (1999). The use of long-term hepatocyte cultures for detecting induction of drug metabolising enzymes: the current status. ECVAM hepatocyte and metabolically competent systems task force report 1. ATLA 27, 579-638.
17. Wiebel, F.J., Andersson, T.B., Casciano, D.A., Dickins, M., Fischer, V., Glatt, H., Horbach, J., Langenbach, R.J., Luyten, W., Turchi, G. & Vandewalle, A. (1997). Genetically engineering cell lines: characterisation and applications in toxicity testing. Report and recommendations of ECVAM workshop 26. ATLA 25, 625-639.
18. Coecke, S., Bogni, A., Langezaal, I., Worth, A., Hartung, T. & Monshouwer, M. (2001). The use of genetically engineered cells for assessing CYP2D6-related polymorphic effects. Toxicology in Vitro 15, 2553-2556.
19. Dearden, J.C., Barratt, M.D., Benigni, R., Bristol, D.W., Combes, R.D., Cronin, M.T.D., Judson, P.M., Payne, M.P., Richard, A.M., Tichy, M., Worth, A.P. & Yourick, J.J. (1997). The development and validation of expert systems for predicting toxicity. The report and recommendations of an ECVAM/ECB workshop (ECVAM workshop 24). ATLA 25, 223-252.
20. Greene, N., Judson, P.N., Langowski, J.J. & Marchant, C.A. (1999). Knowledge-based expert systems for toxicity and metabolism predictions: DEREK, StAR and METEOR. SAR & QSAR in Environmental Research 10, 299-314.
21. Combes, R.D. & Judson, P. (1995). The use of artificial intelligence systems for predicting toxicity. Pesticide Science 45, 179-194.
22. Langowski, J. & Long, A. (2002). Computer systems for the prediction of xenobiotic metabolism. Advanced Drug Delivery Reviews 54, 407-415.
23. Darvas, F., Szabó, I., Karancsi, T., Slégel, P., Dormán, G., László, Ü. & Krajcsi, P. (2002). Dual uses of in silico and in vitro metabolism data in lead discovery, ComGenex' MAID is a metabolism alerting system for the early phase of drug discovery. Genetic and Engineering News 22, 32-34.
24. Worth, A.P., Barratt, M.D. & Houston, J.B. (1998). The validation of computational prediction techniques. ATLA 26, 241-247.
25. Worth, A.P. & Cronin, M.T.D. (2003). Report of the workshop on the validation of QSARs and other computational prediction models. Proceedings of the Fourth World Congress on Alternatives and Animal Use if the Life Sciences, New Orleans, 2002. ATLA 31, Suppl. 2, in press.
26. Barratt, M.D., Castell, J.V., Chamberlain, M., Combes, R.D., Dearden, J.C., Fentem, J.H., Gerner, I., Giuliani, A., Gray, T.J.B., Livingstone, D.J., Provan, W.M., Rutten, F.A.J.J.L., Verhaar, H.J.M. & Zbinden, P. (1995). The integrated use of alternative approaches for predicting toxic hazard. The report and recommendations of ECVAM workshop 8. ATLA 23, 410-429.
27. Zinke, S., Gerner, I. & Schlede, E. (2002). Evaluation of a rule base for identifying contact allergens by using a regulatory database: comparison of data on chemicals notified in the European Union with "Structural Alerts" use in the DEREK Expert System. ATLA 30, 285-298.
28. Blaauboer, B.J., Barratt, M.D. & Houston, J.B. (1999). The integrated use of alternative methods in toxicological risk evaluation. ECVAM integrated testing strategies task force report 1. ATLA 27, 229-237.
29. Blauuboer, B.J. (2002). The applicability of in vitro-derived data in hazard identification and characterisation of chemicals. Environmental Toxicology and Pharmacology 11, 213-225.
30. European Centre for the Ecotoxicology and Toxicology of Chemicals (2002). Outline concept of a pragmatic approach to risk assessment. Web site www.ecetoc.org (Accessed 3.8.02).
31. The Oil Companies' European Organisation for Environment, Health and Safety (2001). Suggested approach to the basic ranking of exposure under the REACH scheme. Web site www.concawe.be (Accessed 20.11.02).