Study sounds warning note on BADGE-based epoxy resins

Aluminum pharmaceutical tubes are often coated internally with bisphenol A diglycidyl ether (BADGE)-based epoxy resins - and according to a new study from Germany, this may present a problem for people who manufacture or work with these tubes.

The study, headed by Kristine Breuer, M.D., of Dermatologikum Hamburg, suggests that exposure to such equipment can result in contact-allergy reactions.

The research team examined the safety of BADGE-contaminated ointments in individuals sensitized to BADGE-based epoxy resins by use tests. The researchers administered repeated open application testing to 11 patients.

Three patients were found to have reactions to 30 mg/kg BADGE ointment, while three more 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 epoxy-resin-coated aluminum tubes pose a risk of developing contact dermatitis to patients sensitized to epoxy-resin based on BADGE,” the authors wrote, adding that quality standards should be mandatory for the production and use of epoxy-resin-coated aluminum tubes.

The study was published online Oct. 29 in Allergy.

Reference: Breuer K, Lipperheide C, Likpe U, et al. Contact allergy induced by bisphenol A diglycidyl ether leachables from aluminum tubes for pharmaceutical use. Allergy. 29 Oct 2014 [Epub ahead of print] http://onlinelibrary.wiley.com/doi/10.1111/all.12538/abstract