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BADGE Exposure Can Elicit Contact Allergy Reactions

Reactions elicited with exposure to bisphenol A diglycidyl ether-contaminated macrogol ointments

THURSDAY, Nov. 6, 2014 (HealthDay News) -- Exposure to aluminum tubes for pharmaceutical use that are internally lacquered with epoxy resins (ER) based on bisphenol A diglycidyl ether (BADGE) can elicit contact allergy reactions, according to a study published online Oct. 29 in Allergy.

Kristine Breuer, M.D., Ph.D., from Dermatologikum Hamburg in Germany, and colleagues examined the safety of BADGE-contaminated macrogol ointments in individuals sensitized to ER based on BADGE by use tests. Eleven patients underwent repeated open application testing (ROAT).

The researchers found that three patients had reactions to 30 mg/kg BADGE ointment, and another three had reactions to 300 mg/kg ointment. There was no evidence of reactions to the vehicle control or to 3 mg/kg BADGE.

"Elevated BADGE concentrations in ER-coated aluminum tubes pose a risk of developing contact dermatitis to patients sensitized to ER based on BADGE," the authors write. "Quality standards are deemed necessary for the production of ER-coated aluminum tubes intended for pharmaceutical use and should consider the results of the present ROAT study."

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