Practical Aspects of the Validation of Toxicity Test Procedures

The Report and Recommendations of ECVAM Workshop 51,2

Reprinted with minor amendments from ATLA 23, 129-147.

Appendix A: Terminology

Validation is the process by which the reliability and relevance of a procedure are established for a specific purpose.

Reliability of a procedure describes whether it can be performed reproducibly within and among laboratories and over time.

Relevance of a procedure describes whether it is meaningful and useful for a particular purpose.

Test development is the process by which the components of a protocol (e.g. experimental system, exposure conditions, endpoint, endpoint measurement and data analysis procedures) are defined for a specific purpose, and is normally carried out in the laboratory of origin.

Interlaboratory assessment establishes whether or not a test can be successfully transferred from one laboratory to another. It should include two phases: pre-validation, which results in fine-tuning of the study design and final optimisation and agreement of the standard protocol to be used, and formal validation, in which a set of test chemicals is evaluated by the standard protocol.

Procedure refers to a test, test battery or testing strategy.

Test refers to the combination of the experimental system used, exposure conditions, endpoint, endpoint measurement and data analysis method.

Endpoint refers to the processes, responses or effects assessed.

Endpoint measurement refers to the techniques used to assess endpoints.

Protocol refers to the precise step-by-step description of a test.

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