Contact allergy induced by bisphenol A diglycidyl ether leachables from aluminium tubes for pharmaceutical use
| Autor: | Sonja Molin, Uwe Lipke, Vera Mahler, Claudia Pföhler, Kristine Breuer, Cornelia Lipperheide, H. Löffler, Axel Schnuch, Thomas Zapf, H. Schwantes, Heinrich Dickel, Regina Treudler |
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| Rok vydání: | 2015 |
| Předmět: |
Adult
Male Macrogol Immunology chemistry.chemical_element Macrogol ointment Ointments Young Adult chemistry.chemical_compound Aluminium medicine Humans Immunology and Allergy Benzhydryl Compounds Bisphenol A diglycidyl ether Allergic contact dermatitis Aged Chromatography Epoxy Middle Aged Patch Tests medicine.disease 3. Good health chemistry Contact allergy visual_art Dermatitis Allergic Contact visual_art.visual_art_medium Epoxy Compounds Female Contact dermatitis Aluminum |
| Zdroj: | Allergy. 70:220-226 |
| ISSN: | 0105-4538 |
| DOI: | 10.1111/all.12538 |
| Popis: | Background Aluminium tubes for pharmaceutical use are internally lacquered with epoxy resins (ER) based on bisphenol A diglycidyl ether (BADGE). Recently, it was shown that remnants of ER polymerization like BADGE are extractable from epoxy-based coatings of commercially available tubes and may leach into semi-solid drug preparations. We aimed to evaluate the safety of BADGE-contaminated macrogol ointments in individuals sensitized to ER based on BADGE by use tests. Methods Repeated open application testing (ROAT) in 11 patients sensitized to ER based on BADGE with BADGE in macrogol ointments (3 mg/kg; 30 mg/kg, equivalent to BADGE concentration determined in macrogol ointment after storage in a commercially available tube; 300 mg/kg). Results The 30 mg/kg BADGE ointment elicited reactions in three patients, and another three patients reacted to 300 mg/kg BADGE ointment. No reactions to the vehicle control and 3 mg/kg BADGE were observed. Conclusions Elevated BADGE concentrations in ER-coated aluminium tubes pose a risk of developing contact dermatitis to patients sensitized to ER based on BADGE. Quality standards are deemed necessary for the production of ER-coated aluminium tubes intended for pharmaceutical use and should consider the results of the present ROAT study. |
| Databáze: | OpenAIRE |
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