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Am J Rhinol. 2004 Sep-Oct;18(5):291-9.

Nasal toxicity of benzalkonium chloride.

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  • 1Department of Otorhinolaryngology, University of Ulm, Medical School Prittwitzstr 43, 89075 Ulm, Germany.

Abstract

BACKGROUND:

Benzalkonium chloride (BAC) is added to nasal preparations to prevent microbial contamination. Adverse effects of BAC on human nasal mucosa should be evaluated.

METHODS:

The ciliotoxicity of BAC was assessed in isolated human nasal epithelia from 15 donors. The effects of nasal BAC 0.05% (4 x 200 microL/day for 8 days) on nasal saccharin transport time, inflammatory cells and cytokine levels in nasal secretions, and nasal symptom scores were assessed in a randomized, double-blind crossover trial in 16 healthy volunteers.

RESULTS:

In vitro, BAC was ciliotoxic (p < 0.0001). In vivo, BAC did not alter saccharin transport time in healthy individuals (p > 0.8). No BAC-associated proinflammatory effects were observed. The staining index for myeloperoxidase was 4.8% in the placebo period and 6.3% (p = 0.42) in the BAC period. Also, nasal secretion levels of cytokines and the neuropeptide substance P revealed no BAC-associated differences. Concentrations for interleukin (IL)-6 in the placebo period were 41.5 pg/mL (0.9-91.7 pg/mL) and in the BAC period were 17.6 pg/mL (3.2-65.9 pg/mL; p = 0.46), and concentrations for substance P were 119 pg/mL (58-293 pg/mL) and 131 pg/mL (80-330 pg/mL; p = 0.31), respectively. Immediately after application, BAC caused nasal irritation (p = 0.001), a burning sensation (p = 0.0003), and hypersecretion (p = 0.006). Moreover, BAC caused a persistent sensation of nasal irritation (p < 0.01).

CONCLUSION:

BAC in concentrations used in nasal preparations is ciliotoxic. In healthy individuals, the ciliotoxic effect of BAC is neutralized, probably by components of nasal secretions. No BAC-related proinflammatory effects have been observed. At higher doses than normally used therapeutically, BAC caused significant nasal irritation.

PMID:
15586800
[PubMed - indexed for MEDLINE]
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