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Updated: Jun 20, 2026

Quantification of Tumor Cell Adhesion in Lymph Node Cryosections
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Quantification of Tumor Cell Adhesion in Lymph Node Cryosections

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Potency values from the local lymph node assay: application to classification, labelling and risk assessment.

S E Loveless1, A-M Api, R W R Crevel

  • 1DuPont Haskell Global Centers for Health and Environmental Sciences, Newark, DE, USA. scott.e.loveless@usa.dupont.com

Regulatory Toxicology and Pharmacology : RTP
|September 8, 2009
PubMed
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Skin sensitization: Implications for integration of clinical data into hazard identification and risk assessment.

Human & experimental toxicology·2015

Accurately characterizing skin sensitizing hazards is crucial. The local lymph node assay (LLNA) provides a science-based, four-category system for classifying contact allergens by potency, aiding risk assessment.

Area of Science:

  • Toxicology
  • Dermatology
  • Chemical Safety

Background:

  • Contact allergens pose significant hazards, necessitating accurate identification and characterization.
  • Existing methods for assessing skin sensitization require refinement for classification and risk assessment.

Purpose of the Study:

  • To evaluate the local lymph node assay (LLNA) for defining threshold criteria (EC3 values) for classification and labeling.
  • To reassess existing recommendations for sub-categorizing substances based on potency.
  • To provide recommendations for classifying and labeling preparations under the Globally Harmonized System (GHS).
  • To integrate LLNA data into quantitative risk assessment strategies.

Main Methods:

  • Review of the local lymph node assay (LLNA) and its application in determining EC3 values.

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  • Analysis of concentration-response data for skin sensitizing chemicals.
  • Evaluation of existing frameworks for classifying contact allergens by potency.

    • Main Results:

    • Currently, an EC3 value below 100% cannot be reliably defined as a threshold for classification and labeling.
    • A four-category system ('extreme', 'strong', 'moderate', 'weak') is proposed as the most appropriate science-based classification for contact allergens based on potency.
    • LLNA EC3 values are suitable for determining a no expected sensitization induction level, a key step in quantitative risk assessment.

    Conclusions:

    • The LLNA is a valuable tool for assessing skin sensitization potency.
    • A refined, multi-category classification system based on LLNA data improves the scientific basis for hazard characterization.
    • LLNA data integration into risk assessment provides a quantitative approach to managing skin sensitization risks.