European Centre for Validation

A working group under the auspices of the European Centre for Validation of Alternative Methods has recommended alternative methods that can be used for safer testing of medical devices. These include two in vitro tests as potential substitutes for the in vivo assays for skin and eye irritation. 

Lambre CR, Aufderheide M, Bolton RE, et al. (1996) Authors In Vitro Tests for Respiratory Toxicity. The Report and Recommendations of ECVAM Workshop 18. European Commission, Institute for Health and Consumer Protection, European Centre for Validation of Alternative Methods (ECVAM). (Reprinted with minor amendments from ATLA 24 671-681.)... 

The European Centre for Validation of Alternative Methods (ECVAM) and other organizations have developed and/or recommended tiered testing approaches and strategies to assess eye and skin corrosion and irritation potential. These tiered approaches use in vitro methods and other nonanimal approaches, for example, structure-activity relationship (SAR) models. A tiered testing strategy is now... 

By 1990, ECETOC had published over 100 reports and was recognized officially by the WHO IPCS and the International Agency for Research on Cancer (lARC). Liaison with these and other agencies such as the European Commission s European Chemicals Bureau (ECB) and European Centre for Validation of... 

European Centre for the Validation of Alternative Methods (ECVAM), six in vitro systems for chronic neurotoxicity testing are recommended for further consideration (Worth and Balls 2002). These are described as in vitro models that may be suitable for long-term toxicity testing. The systems are... 

In vitro tools could be used alone or in test batteries with increased potency of the description of cellular events and changes. The chapter provides a brief introduction on the components of an in vitro system, the main differences between models for research and models for testing and a list of validated alternative methods according to the European Centre for the Validation of Alternative Methods (ECVAM) (http // ecvam.jrc.it/, http //ecvam.jrc.ec.europa.eu/) evaluation. 

An important point, made by the European Centre for the Validation of Alternative Methods (ECVAM), is that these 3 aspects (3Rs) should not be considered as alternatives that could replace each other, but as parts of an integrated system which should lead to progress in the development of non-animal tests and testing strategies. Another important key point recently defined by ECVAM is that the use of existing information must be maximized instead of testing methods. 

Alternative tests will have to be validated scientifically and established as acceptable by industry and the regulators before being used for registration. The EU body which undertakes this validation process is the European Centre for the Validation of Alternative Methods (ECVAM), and the US equivalent is the Interagency Co-ordinating Committee on the Validation of Alternative Methods (ICCVAM). 

ECVAM European Centre for the Validation of PEC Predicted environmental concentration... 

To test the irritancy potential of substances, two tests which can reliably distinguish between skin corrosives and noncorrosives are endorsed by the European Centre for the Validation of Alternative Methods (ECVAM). The testing procedures are based on the transcutaneous electrical resistance (TER) measurements of rat skin and on a human skin model. Both test systems [141-145] will be briefly outlined below. Nevertheless, these tests are not suited for the group of mild irritants which do not induce an acute effect on the barrier function. For those substances, new markers need to be evaluated. First results are available for heat shock protein 27 where higher levels were observed in skin models after exposure to mildly irritating chemicals [146, 147]. 

Le Ferrec E, Chesne C, Artursson P, Brayden D, Fabre G, Gires P, Guillou F, Rousset M, Rubas W, Scarino ML (2001) In vitro models of the intestinal barrier. The report and recommendations of ECVAM Workshop 46. European Centre for the Validation of Alternative methods. Altern Lab Anim 29 649-668. 

ECETOC. 2007b. European Centre for Ecotoxicology and Toxicology of Chemicals (publications) website http /www.ecetoc.org/Content/Default.asp PagelD = 21 ECVAM. 2007. European Center for Validation of Alternative Methods website. http /ecvam.jrc.it/index.htm EU. 2006. The DG Environment REACH website. http /ec.europa.eu/environment/chemicals/reach EU. 2007. European Commision, Research Science and Society website The role of ethics in EU research. 

Genschow E, Spiehnann H, Scholz G et al (2002) The ECVAM international validation study on in vitro embryotoxicity tests results of the definitive phase and evaluation of prediction models. European Centre for the Validation of Alternative Methods. Altern Lab Anim 30(2) 151-176... 

One key issue is the requirement for animal testing. The report and recommendations of the European Centre for the Validation of Alternative Methods (ECVAM) workshop (Leahy et al., 1997) clearly state that a major priority is to reduce the number of animals used in pharmacokinetic studies in drug development. As much information as possible should be obtained from alternative sources, such as computer modeling or using data already generated for similar compounds. 

A European Centre for the Validation of Alternative Methods (ECVAM) was created by a Communication from the Commission to the Council and the Parliament in 1991, pointing to a requirement in Directive 86/609/EEC for the protection of animals used for experimental and other scientific purposes, which requires that the Commission and the Member States should actively support the development, validation, and acceptance of methods which could reduce, refine, or replace the use of laboratory animals [11]. As defined in the Communication of the European Commission to Council and the European Parliament, the duties of ECVAM are ... 

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