Registration Dossier
Registration Dossier
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EC number: 305-897-5 | CAS number: 95193-83-2
Endpoint summary
Administrative data
Description of key information
Studies on human volunteers should not be taken into account for the overall assessment of the skin sensitisation potential of the substance.
Additional information
Some data on the sensitisation potential of the substance on humans can be found in literature. Nevertheless, the results from these studies are inconsistent as in some cases (Bjorkner B. (a), 1981) (Bjorkner B. (b), 1983) the skin sensitisation potential of the substance is described on a single patient while in another 2 studies (Kita S., 1987) (Weaver J. E., 1983) the substance did not induce skin sensitisation potential in the human volunteers. Considering the low number of patients and the contradictory results, the studies on human volunteers should not be taken into account for the overall assessment of the skin sensitisation potential of the substance.
Bjorkner B. (a). (1981). Patch test sensitization D&C Yellow No. 11 and simulatneous reaction to Quinolone Yellow. Contact Dermatitis (1981), 7, 1-4.
Bjorkner B. (b). (1983). Contact allergic reaction to D&C Yellow No. 11 and Quinoline Yellow. Contact Dermatitis, 9, 263-268.
Kita S. (1987). Human maximization testing of D & C Yellow no.10 and Yellow no. 11. Contact dermatitis, 1984, 11, 210-213
Weaver J. E. (1983). Dose response relationships in delayed hypersensitivity to quinoline dyes. Contact Dermatitis, 1983, 9, 309-312
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