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Dose-response relationship in skin sensitization

R L Bronaugh1, C D Roberts, J L McCoy

  • 1Center for Food Safety and Applied Nutrition, Food and Drug Administration, Washington, DC 20204.

Food and Chemical Toxicology : an International Journal Published for the British Industrial Biological Research Association
|February 1, 1994
PubMed
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Investigating skin sensitization dose-response in guinea pigs revealed non-linear relationships. Lower concentrations of sensitizers like dinitrochlorobenzene (DNCB) showed flattened responses, potentially underestimating reactions.

Area of Science:

  • Toxicology
  • Dermatology
  • Immunology

Background:

  • Skin sensitization is a significant health concern.
  • Understanding dose-response relationships is crucial for risk assessment.
  • Previous methods may lack sensitivity for weaker sensitizers.

Purpose of the Study:

  • To investigate the dose-response relationship of skin sensitization.
  • To compare the efficacy of different testing methods for dose-response assessment.
  • To evaluate the dose-response curves for both potent and weak skin sensitizers.

Main Methods:

  • Utilized Hartley guinea pigs previously sensitized.
  • Employed dinitrochlorobenzene (DNCB) as a strong sensitizer and p-phenylenediamine (PPDA) as a weaker sensitizer.

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  • Compared the open epicutaneous test (OET), Buehler occlusive patch test, and maximization test for dose-response evaluation.

    • Main Results:

    • A clear dose-response gradation was observed for DNCB using OET and Buehler tests.
    • OET and Buehler tests were insufficient for PPDA dose-response due to low responder incidence at high doses.
    • The maximization test was effective for PPDA.
    • Both DNCB and PPDA exhibited non-linear dose-response curves, flattening at lower concentrations.

    Conclusions:

    • Skin sensitization dose-response curves are non-linear, particularly at lower concentrations.
    • Assuming linearity can lead to underestimation of risk for weak sensitizers at typical exposure levels.
    • Testing methodologies should be carefully selected based on the sensitizer's potency.