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Dimethylfumarate: potency prediction and clinical experience

David A Basketter1, Ian R White, Florence G Burleson

  • 1DABMEB Consultancy Ltd, Sharnbrook MK44 1PR, UK. dabmebconsultancyltd@me.com

Contact Dermatitis
|April 17, 2013
PubMed
Abstract

Insights

Dimethylfumarate (DMF) is a strong skin sensitizer. The widespread allergic contact dermatitis outbreak was caused by prolonged exposure to DMF in leather products, not just its intrinsic potency.

Area of Science:

  • Dermatology
  • Toxicology
  • Immunology

Background:

  • Dimethylfumarate (DMF) caused a widespread allergic contact dermatitis outbreak, termed 'toxic sofa dermatitis', due to its use as an antifungal in leather goods.
  • The outbreak highlighted the need to understand factors contributing to DMF-induced skin reactions.

Purpose of the Study:

  • To investigate if the frequency and severity of allergic contact dermatitis from DMF were related to its inherent potency or the extent of exposure.
  • To quantify the skin-sensitizing potential of DMF.

Main Methods:

  • The intrinsic skin-sensitizing potency of Dimethylfumarate (DMF) was assessed using the standard local lymph node assay (LLNA).
  • An EC3 value, indicating the concentration required for a 3-fold increase in lymphocyte proliferation, was determined as a measure of relative skin-sensitizing potency.

Main Results:

  • The EC3 value for DMF was determined to be 0.35% in dimethylformamide, classifying it as a strong, but not extreme, skin sensitizer in the mouse model.
  • This potency is comparable to that of formaldehyde, another known strong human skin sensitizer.

Conclusions:

  • The high incidence and severity of allergic contact dermatitis linked to DMF suggest that prolonged, repeated, and occlusive exposure over large skin areas, combined with its strong sensitizing ability, created conditions for an epidemic.
  • The findings underscore the critical role of exposure patterns in the development of chemical-induced allergic contact dermatitis.

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