An animal model assessment of common dye–induced allergic contact dermatitis

Abstract

Dyes are a category of substances capable of inducing allergic contact dermatitis found in a variety of foods, drugs, textiles, cosmetics, and hair dyes. This study tested 33 dyes in guinea pigs using a modified Buehler and Klecak method for open epicutaneous testing. The dyes were tested at an induction concentration of 10% and challenge concentrations of 10.0%, 5.0%, and 2.5%. Nine of the 33 dyes tested produced positive allergic reactions in the guinea pig model (2‐amino‐4‐nitrophenol, 2‐amino‐5‐nitrophenol, acid yellow 23, acid orange 3, basic black 3, basic orange 1, disperse orange 3, solvent black 27, and solvent black 34). When eight of the nine positive dyes were retested using a 1% induction concentration, five dyes produced allergic contact dermatitis at a 1% challenge concentration (2‐amino‐4‐nitrophenol, 2‐amino‐5‐nitrophenol, acid yellow 23, disperse orange 3, and solvent black 34), two at a 0.5% challenge concentration (2‐amino‐5‐nitrophenol and solvent black 34), and one at a 0.25% challenge concentration (2‐amino‐5‐nitrophenol). DNCB at a 0.5% induction/challenge concentration was used as a positive control. With the exception of disperse orange 3 and acid yellow 23, the seven additional dyes that elicited positive allergic reactions in the guinea pig model have not been previously reported.

HC Yellow No. 4

“…1 The Expert Panel reviewed newly available studies since that assessment along with updated information regarding types and concentrations of use. 2 –6 The Expert Panel determined to not reopen this safety assessment. Therefore, the Expert Panel confirmed the original conclusion that HC Yellow No.…”

Sensitizing capacity of Disperse Orange 1 and its potential metabolites from azo reduction and their cross‐reactivity pattern

“…The most investigated disperse dyes regarding their sensitizing capacity are Disperse Blue 124 and 106, Disperse Orange 3, and Disperse Yellow 3 . When discussing sensitizing capacity, it is important to know that the investigated substances do not contain other substances, but, in these aforementioned studies, the purity of the tested dyes was not reported.…”

Acid Orange 3

“…An extensive search of the world’s literature was performed for studies dated 1997 forward, and new data were found. 4-7 The Expert Panel agreed that an updated search of the published literature did not reveal toxicity data that warrant re-evaluation of the safety of this ingredient in cosmetic products. The Expert Panel did note that the European Union has banned Acid Orange 3 for use in cosmetic products; however, this ban is due to a lack of safety test data and not because of any toxicological findings.…”

“…An extensive search of the world's literature was performed for studies dated 1997 forward, and new data were found. [4][5][6][7] The Expert Panel agreed that an updated search of the published literature did not reveal toxicity data that warrant reevaluation of the safety of this ingredient in cosmetic products.…”