The sensitization potential of D & C Yellow No. 11 in guinea pigs.

The certified drug and cosmetic dye substance known as D & C Yellow No. 11 [2-(2-quinolyl)-1,3 indandione] was tested for its dermal sensitization potential in guinea pigs. An induction regimen consisting of a single footpad injection of Complete Freund's Adjuvant diluted with antigen, and an intradermal injection of antigen, produced delayed-type hypersensitivity reactions. A high sensitization frequency was observed with 50 micrograms D & C Yellow No. 11 and the positive control 2,4-dinitrochlorobenzene (DNCB). The reaction severities of both DNCB and 50 micrograms D & C Yellow No. 11 were comparable. A dose-response profile was obtained with D & C Yellow No. 11 employing several concentrations (50, 250 and 500 micrograms/ml). Histologic examination of selected skin sites demonstrated a cellular inflammatory response which was consistent with delayed-type hypersensitivity.