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The Local Lymph Node Assay

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Alternatives for Dermal Toxicity Testing

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Abstract

The local lymph node assay (LLNA) was the first alternative method to undergo formal validation for skin sensitisation hazard identification, followed by the challenges of regulatory acceptance, and so provided lessons for the entire process. What ensued has been instructive for test developers and those involved in validation and acceptance: widespread use of the LLNA led to questions and challenges not anticipated in the development and validation activity; the LLNA was applied to regulatory toxicology, such as in testing of formulations, despite no evidence of functionality for that purpose; perceived imperfections with the assay led some to view the preceding guinea pig methods with rosy nostalgia, even though those methods had not been validated. However, for the toxicology community, the main interest was the evolution of the LLNA from a hazard identification tool to a technique for measurement of the relative potency of skin sensitising chemicals. It is in this manifestation that the LLNA has proven of greatest utility in terms of driving improvements in risk assessment, risk management and protection of human health.

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Author information

Authors and Affiliations

  1. DABMEB Consultancy Ltd, Sharnbrook, MK44 1PR, UK

    David A. Basketter

  2. Faculty of Life Sciences, University of Manchester, Michael Smith Building, Oxford Road, Manchester, M13 9PT, UK

    Ian Kimber

  3. The Procter and Gamble Company, Central Product Safety, Mason, OH, 45040, USA

    G. Frank Gerberick

Authors
  1. David A. Basketter
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  2. Ian Kimber
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  3. G. Frank Gerberick
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Corresponding author

Correspondence to David A. Basketter .

Editor information

Editors and Affiliations

  1. SeCAM, Magliaso, Switzerland

    Chantra Eskes

  2. Innovitox Consulting & Services, Houten, The Netherlands

    Erwin van Vliet

  3. Department of Dermatology, University of California School of Medicine, San Francisco, California, USA

    Howard I. Maibach

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Basketter, D.A., Kimber, I., Gerberick, G.F. (2017). The Local Lymph Node Assay. In: Eskes, C., van Vliet, E., Maibach, H. (eds) Alternatives for Dermal Toxicity Testing. Springer, Cham. https://doi.org/10.1007/978-3-319-50353-0_15

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  • DOI: https://doi.org/10.1007/978-3-319-50353-0_15

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