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Abstract for IMM91024

Immunotoxicity of Fluconazole (FLU) in Female B6C3F1 Mice

CASRN: 86386-73-4
Chemical Formula: C13H12F2N6O
Molecular Weight: 306.2748
Report Date: June 1992


The following abstract presents results of a study conducted by a contract laboratory for the National Toxicology Program. The findings have not been peer reviewed and were not evaluated in accordance with the levels of evidence criteria established by NTP in March 2009. The findings and conclusions for this study should not be construed to represent the views of the NTP or the U.S. Government.

Fluconazole (FLU) was selected for evaluation as a sensitizing agent for contact hypersensitivity in mice. Fluconazole is marketed as Diflucan by the Roerig Division of Pfizer Incorporated. It is the first of a new class of synthetic broad-spectrum bis-triazole antifungal agents. The PDR indicates that skin rash was associated with 1.8% of 4048 patients receiving Diflucan for 7 or more days. No examples of contact hypersensitivity in human subjects or animal models could be found in the recent literature.

The objective of this study was to determine the sensitizing potential of fluconazole when applied dermally to female B6C3F1 mice.

Fluconazole was tested on female B6C3F1 mice. The doses of fluconazole ranged from 1.0% to 10% in 100% ethanol for sensitization and 10% for challenge. Mice received 20 µl by direct dermal application for 5 consecutive days to a prepared site. Site preparation included intradermal injection of Freund's complete adjuvant in some mice. DNFB (1-fluoro-2,4-dinitrobenzene, 99.6%, Sigma Chemical Co.) was used as a positive control at a concentration of 0.25% for sensitization and 0.5% for challenge. Measurement of the contact hypersensitivity response was accomplished by the mouse ear swelling test (MEST).

No statistically significant (p < 0.05) or dose-dependent (p < 0.05) contact hypersensitivity response to fluconazole could be detected.


Summary of Irritancy and Contact Hypersensitivity Results
Type of Response   Method Used Adjuvant Dose Response
(p < 0.05)
Positive Response
(p < 0.05)
Irritation   Radioisotopic
No No No
Day +1 MEST No
  Day +2 MEST No

Abbreviations: MEST = Mouse Ear Swelling Test