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Related Experiment Videos

Local lymph node assay - validation, conduct and use in practice.

D A Basketter1, P Evans, R J Fielder

  • 1SEAC, Unilever Colworth House, Sharnbrook, Beds MK44 1LQ, UK. david.basketter@unilever.com

Food and Chemical Toxicology : an International Journal Published for the British Industrial Biological Research Association
|April 17, 2002
PubMed
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The local lymph node assay (LLNA) is a validated alternative to animal testing for identifying skin sensitization hazards. This report examines its regulatory validation and flexibility for global toxicological needs.

Area of Science:

  • Toxicology
  • Regulatory Science
  • In vitro testing

Background:

  • The validation of alternative methods in toxicology is an emerging field.
  • The local lymph node assay (LLNA) is a novel method for identifying chemicals that cause skin sensitization.
  • The LLNA was the first test to undergo formal regulatory validation in the USA through ICCVAM.

Purpose of the Study:

  • To explore the nine recommendations made by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM).
  • To discuss the interpretation of ICCVAM recommendations in relation to the OECD Guideline 429 for the LLNA.
  • To examine the value and limitations of statistical data evaluation and positive controls in the LLNA.

Main Methods:

  • Review of ICCVAM recommendations.

Related Experiment Videos

  • Analysis of OECD Guideline 429.
  • Discussion of statistical evaluation and positive controls in the context of the LLNA.

    • Main Results:

    • ICCVAM approved the LLNA as an alternative to guinea pig tests for skin sensitization hazard identification.
    • The study examines the interpretation of ICCVAM's nine recommendations concerning the LLNA.
    • The utility of statistical analysis and positive controls within the LLNA framework is evaluated.

    Conclusions:

    • The OECD Guideline 429 for the LLNA offers flexibility for regulatory agencies and toxicologists worldwide.
    • The LLNA is a validated alternative method for assessing skin sensitization.
    • The current OECD Guideline accommodates diverse regulatory and toxicological requirements.