The Use of In Vitro Systems for Evaluating Immunotoxicity: The Report and Recommendations of an ECVAM Workshop

Abstract

This is the report of a workshop organised by the European Centre for the Validation of Alternative Methods (ECVAM). ECVAM's main goal, as defined in 1993 by its Scientific Advisory Committee, is to promote the scientific and regulatory acceptance of alternative methods that are of importance to the biosciences and which replace, reduce or refine the use of laboratory animals. One of the first priorities set by ECVAM was the implementation of procedures that would enable it to become well informed about the state-of-the-art of non-animal test development and validation, and the potential for the possible incorporation of alternative tests into regulatory procedures.

It was decided that this would be best achieved by the organization of ECVAM workshops on specific topics, at which small groups of invited experts would review the current status of various types of in vitro tests and their potential uses, and make recommendations about the best ways forward ().

The workshop on “The use of in vitro systems for evaluating Immunotoxicity” was held at ECVAM (Ispra), Italy, on 24th–26th November 2003. The participants represented academia, national organizations, international regulatory bodies and industry. The aim of the workshop was to review the state-of-the-art in the field of in vitro immunotoxicology, and to develop strategies towards the replacement of in vivo testing. At the end of this report are listed the recommendations that should be considered for prevalidation and validation of relevant and reliable procedures, that could replace the use of animals in chemical and cosmetics toxicity testing.

Keywords :

• in vitro
• methods
• immunosuppression
• alternative models

Notes

Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. O.J. L 196/1 of 16 August 1967. And related Amendments, Adaptations to Technical Progress, Commission Decisions, and Commission Communications.

〈http://europa.eu.int/comm/enterprise/chemicals/chempol/ whitepaper/consultation.htm〉.

OECD Guidelines for the Testing of Chemicals, 1997, vol. 1, no. 4, pp. 1–8.

OECD Guidelines for the Testing of Chemicals, 1997, vol. 1, no. 4, pp. 1–10.

OECD Guidelines for the Testing of Chemicals, 1997, vol. 1, no. 4, pp. 1–14.

Note for Guidance on Repeated Dose Toxicity, CPMP/SWP/ 1042/99, 〈http://www.emea.eu.int/pdfs/human/swp/104299en.pdf 〉.

CDER Guidance for Industry: Immunotoxicology Evaluation of Investigational New Drugs, October 2002 〈http://www.fda.gov/ cder.guidance/4945fnl.doc〉

CDRH Guidance for Industry and FDA Reviewers—Immunotoxicity testing Guidance, May 1999 〈http://www.fda.gov/ cdrh/ost/ostggp/immunotox.html〉

Health Effects Test Guidelines (ftp:fedbbs.access.gpo.gov (IP 162.140.64.19).OPPTS 870.7800 Immunotoxicity. OPPTS 870.2600 Skin Sensitization.

ICICIS, Report of Validation Study of Assessment of Direct Immunotoxicity in the Rat. Toxicology, 125, 183, 1998.