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
Not sensitiser to skin.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitisation potential of the substance is evaluated mainly using two in vitro skin sensitisation assay addressing the key event of activation of dendritic cells on the adverse outcome pathway for skin sensitisation (OECD 442e, GLP study) and two in vivo studies on Guinea pigs, a Guinea Pig Maximisation Test (Sato Y., 1984) and a test performed according to a modified Buehler Method (Lamson S.A., 1982). In the first OECD 442e study the substance induced IL-8 activation in THP-1 derived IL-8 reporter cell line. The test item was purified and subsequently, the IL-8 Luc assay was performed on the purified batch in a second test. The purified test item did not induce IL-8 activation in THP-1 derived IL-8 reporter cell line in all the three independent runs at all the concentration tested. Thus, the first IL-8 Luc assay was disregarded. For additional information see the attachment. Under the conditions of the two in vivo studies on Guinea pigs, the substance did not induce skin sensitisation. Nevertheless, the study by Lamson et al (Lamson S.A., 1982) is not reliable as in the negative control group a high number of animals developed skin sensitisation.
Some data on the skin sensitisation potential of the substance on humans can be found in literature. In 2 studies (Kita S., 1987) (Weaver J. E., 1983) the substance did not induce skin sensitisation potential in human volunteers. Nevertheless, the results of other two studies (Bjorkner B. (a), 1981) (Bjorkner B. (b), 1983) describe the skin reaction to Quinoline Yellow. The study of 1981 reported that the 1% Quinoline Yellow_10 induced a positive skin reaction after 72 h application on a single patient (out of 88 patients tested). However, the substance was applied to the skin of the patient after two previous application of the skin sensitizer Quinoline Yellow_11. In the study of 1983, a single patient was tested. The patient was first exposed to Quinoline Yellow_11 and then to Quinoline Yellow_10 contamined by Quinoline Yellow_11. Therefore, the two studies of Bjorkner of 1981 and 1983 should be carefully considered for the overall assessment of the skin sensitisation potential of substance.
The skin sensitisation potential of the substance has been evaluated also in silico with QSAR Toolbox v4.5. The main profiling methods related to the sensitization were selected. The substance did not match any of the criteria of the profiling scheme and no alerts were generated for skin sensitization.
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.
Lamson S.A. (1982). D&C Yellow Nos. 10 and 11: delayed contact hypersensitivity in the guinea pig.
Sato Y. (1984). D&C nos. 10 and 11: chemical composition analysis and delayed contact hypersensitivity testing in the guinea pig.
Weaver J. E. (1983). Dose response relationships in delayed hypersensitivity to quinoline dyes. Contact Dermatitis, 1983, 9, 309-312.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In the OECD 442e study the substance did not induced IL-8 activation in THP-1 derived IL-8 reporter cell line. This test method addresses only the Key Event related to Dendritic Cells activation, the third Key Event of the skin sensitisation Adverse Outcome Pathway (AOP). Under the conditions of the test, the substance shall not be classified as Skin Sensitiser according to the CLP Regulation (EC) No. 1272/2008. The results obtained by the IL-8 Luc assay are consistent with other in-vivo studies on Guinea Pigs and epidemiological studies on human, indicating that the substance is not a skin sensitizer.
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