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Related Experiment Videos

Validation successes: chemicals.

Horst Spielmann1, Manfred Liebsch

  • 1National Centre for Documentation and Evaluation of Alternative Methods to Animal Experiments (ZEBET), Federal Institute for Health Protection of Consumers and Veterinary Medicine (BgVV), Diedersdorfer Weg 1, 12277 Berlin, Germany.

Alternatives to Laboratory Animals : ATLA
|January 7, 2003
PubMed
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The European Centre for the Validation of Alternative Methods (ECVAM) validation concept has led to the acceptance of validated in vitro toxicity tests for phototoxicity, skin corrosivity, and embryotoxicity by regulatory agencies worldwide.

Area of Science:

  • Toxicology
  • Regulatory Science
  • In Vitro Testing

Background:

  • The ECVAM validation concept, established in 1990 and 1994, incorporates prevalidation and biostatistically defined prediction models.
  • This concept has gained official acceptance from EU Member States, US federal regulatory agencies, and the OECD.

Purpose of the Study:

  • To introduce and apply the ECVAM validation concept to in vitro toxicity tests.
  • To validate and promote the regulatory acceptance of alternative testing methods.

Main Methods:

  • Application of the ECVAM validation concept to in vitro phototoxicity, skin corrosivity, and embryotoxicity tests.
  • Experimental validation studies conducted between 1996 and 2000.

Main Results:

Related Experiment Videos

  • The 3T3 neutral red uptake in vitro phototoxicity test was the first validated in vitro toxicity test recommended for regulatory use by ESAC and accepted into EU legislation in 2000.
  • Two in vitro skin corrosivity tests were validated and accepted into EU regulations in 2000.
  • Three in vitro embryotoxicity tests (WEC, MM, EST) were successfully validated and are considered for routine use.

Conclusions:

  • The ECVAM validation concept has successfully facilitated the validation and regulatory acceptance of key in vitro toxicity tests.
  • Validated in vitro tests for phototoxicity, skin corrosivity, and embryotoxicity are poised for wider regulatory and industrial adoption globally.