Dermatitis to FD &C Yellow No. 6 Dye in Orange Antiseptic Solution

A 25-year-old white man was referred for an intensely pruritic erythematous papular and vesicular eruption on his right forearm (Figure 1A) that began several days after placement of a long arm plaster cast after an open reduction and internal fixation for a right ulnar styloid fracture. An orange hue could be seen under the cotton in his cast (Figure 1B). The only antiseptic that had been used during the surgery was Hi-Lite Orange ChloraPrep (CareFusion, Leawood, Kansas); tincture of benzoin was not used. The eruption resolved with application of triamcinolone acetonide, 0.1%, ointment before recasting the arm.

ChloraPrep is an antiseptic containing isopropyl alcohol, 70%, chlorhexidine gluconate, 2%, and purified water; Hi-Lite Orange ChloraPrep is identical except that it also contains Federal Food, Drug, and Cosmetic Act (FD &C) yellow No. 6 dye (proprietary amount)¹ in a polyester pledget through which the alcohol and chlorhexidine mixture flows. Patch testing was performed with the 29-allergen T.R.U.E. Test (SmartPractice, Phoenix, Arizona), as well as the ChloraPrep with and without orange tint, in standard patch testing and open application testing on bilateral forearms. The only allergen on the T.R.U.E. test to provoke a positive reaction was balsam of Peru (Myroxylon pereirae resin), 2+ reaction at 96 hours. Open application testing of ChloraPrep with orange tint showed a 2+ reaction at 48 and 96 hours, but the ChloraPrep without tint was nonreactive (Figure 2). Standard patch testing showed a 1+ reaction for ChloraPrep with orange tint and no reaction for Chloraprep without tint. Open application testing of the ChloraPrep with orange tint was performed in 10 volunteers; all were nonreactive.

The combination of alcohol and chlorhexidine is used perioperatively because it is associated with lower positive culture rates than povidone-iodine or iodine plus alcohol.² A representative from the manufacturer reported that the irritation rate to ChloraPrep is less than 1%, but eruptions have occurred after breast and orthopedic surgical procedures, presumably increased by the immediate occlusive dressings or casts (Amy Taitt, RN, e-mail communication, April 24, 2009). The Material Safety Data Sheet for ChloraPrep with orange tint states that “prolonged contact may cause dermatitis. ”¹ Allergic contact dermatitis to chlorhexidine is rare but has been reported³ ; that possibility is excluded in this case by the lack of reaction to the ChloraPrep without tint.

Federal Food, Drug, and Cosmetic Act yellow No. 6 dye is an azo dye that is also called Sunset Yellow FCF (CI 15985), E110, or disodium 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfononate. Allergic contact dermatitis to FD &C yellow No. 6 dye has rarely been reported; Guin⁴ patch tested 144 patients to FD &C yellow No. 6 dye and found 4 positive reactions. A commercial patch test to FD &C yellow No. 6 dye is not available, but patch test studies of other yellow dyes show high concentrations may be needed and that test results may not be reproducible over time.^{5 - 6} Federal Food, Drug, and Cosmetic Act yellow No. 6 dye has been associated with gastroenteritis, asthma, urticaria, and anaphylactoid reactions.^{7 - 8}

It appears that this patient had an allergic contact dermatitis to FD &C yellow No. 6 dye. It is possible that the occlusion following orthopedic surgery creates a condition under which this arises. Inactive ingredients can be a cause of many ailments including contact dermatitis.^{8 - 9}