Why 'suitable' in vitro methods, as defined in the final EU REACH legislation, are an inappropriate basis for risk assessment

Alternatives to Laboratory Animals

Volumn 35, Issue 2, 2007, Pages 289-293

  Combes, Robert D ^a  

^a RUSSELL AND BURCH HOUSE   (United Kingdom)

Author keywords

'Suitable' test methods; Final REACH legislation; Risk assessment; Validation

Indexed keywords

ANIMAL TESTING ALTERNATIVE; DRUG DOSE REGIMEN; IN VITRO STUDY; LAW; NONHUMAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; RISK ASSESSMENT; VALIDATION PROCESS; VALIDITY;

EID: 34249984157     PISSN: 02611929     EISSN: None     Source Type: Journal    
DOI: 10.1177/026119290703500202     Document Type: Review

References (15)

1. Grindon, C. (2007). The new EU REACH regulation has finally been adopted: Is this the end of the campaign trail or just the beginning...? ATLA 35, 239-242.
2. Anon. (2006). Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC and 2000/21/EC. Official Journal of the European Union L396, 849pp. Brussels, Belgium: European Commission. Website http://eur-lex.europa.eu/LexUriServ/site/ en/oj/2006/1_396/1_39620061230en00010849.pdf (Accessed 20.02.07).
3. Anon. (2001). Strategy for a Future Chemicals Policy (COM(2001)88 final), 32pp. Brussels, Belgium: European Commission: Website http://europa.eu.int/comm/environment/chemicals/whitepaper.htm (Accessed 08.01.01).
4. Combes, R., Barratt, M. & Balls, M. (2003). An overall strategy for the testing of chemicals for human hazard and risk assessment under the EU REACH system. ATLA 31, 7-19.
5. Grindon, C., Bhogal, N., Combes, R. & Balls, M. (2005). The scientific, animal welfare and regulatory implications of the EU REACH system for chemical safety. TOPRA Regulatory Rapporteur 2, 16-22.
6. Grindon, C., Combes, R., Cronin, M.T.D., Roberts, D.W. & Garrod, J.F. (2006). Integrated testing strategies for use in the EU REACH system. ATLA 34, 407-427.
7. Grindon, C., Combes, R., Cronin, M.T.D., Roberts, D.W. & Garrod, J.F. (2006). Integrated decision-tree testing strategies for environmental toxicity with respect to the requirements of the EU REACH legislation. ATLA 34, 651-664.
8. Anon. (2007). General Guidelines for Submitting a Proposal to ECVAM for the Evaluation of the Readiness of a Test Method to Enter the ECVAM Prevalidation and/or Validation Process. Ispra, Italy: European Centre for the Validation of Alternative Methods. Website http://ecvam-sis.jrc.it/ upload_docs/m_5/Guidelines.pdf (Accessed 27.02.07).
9. Stokes, W.S., Schechtman, L.M. & Hill, R.N. (2002). The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM): a review of the ICCVAM test method evaluation process and current international collaborations with the European Centre for the Validation of Alternative Methods (ECVAM). ATLA 30, Suppl. 2, 23-32.
10. Anon. (2005). Guidance Document on the Validation and International Acceptance of New or Updated Test Methods for Hazard Assessment. OECD Series on Testing and Assessment. Number 34, Environment Directorate Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology, 96pp. Paris, France: OECD.
11. Combes, R. & Balls, M. (2003). How much flexibility is possible when validating new in vivo and in vitro toxicity test methods? ATLA 31, 225-232.
12. Combes, R., Balls, M., Illing, P., Bhogal, N., Dale, J., Duvé, G., Feron, V., Grindon, C., Gülden, M., Loizou, G., Priston, R. & Westmoreland, C. (2006). Possibilities for a new approach to chemicals risk assessment - The Report of a FRAME Workshop. ATLA 34, 621-649.
13. Balls, M. & Combes, R. (2005). The need for a formal invalidation process for animal and non-animal tests. ATLA 33, 299-308.
14. Combes, R. & Balls, M. (2005). Intelligent testing strategies for chemicals testing - A case of more haste, less speed? ATLA 33, 289-297.
15. Combes, R.D. (2006). The OECD Health Effects Test Guidelines for REACH need updating. ALTEX 23, Special Issue, 124-130.