1,4-Benzenedisulfonic acid, 2,2'-[1,2-ethenediylbis[(3-sulfo-4,1-phenylene)imino[6-[bis(2-hydroxypropyl)amino]-1,3,5-triazine-4,2-diyl]imino]]bis-, sodium salt (1:6)

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Reliable data have been obtained on skin sensitisation of two members of the category of derivatives of 4,4’-bis(1,3,5-triazinyl-2-yl)amino)stilbene-2,2’-disulfonic acid, each with one anilino and one alkyl amino moiety: 476-900-6 and EC 416-640-2. Both substances were found to be non-sensitizer. Therefore, it is concluded that the substance defined in section1 is not sensitising to skin and have not to be classified for skin sensitisation.

EC 476-900-6:

The substance was tested in an OECD 429 LLNA (Skin Sensitisation: Local Lymph Node Assay) test. The test substance was applied to the mouse ear at concentrations of 5%, 10% and 25 % in ethanol/ water, 7/3 v/v. No clinical signs were observed in any animal of groups 0% (control), 5% and 10%. On second application day a slight erythema was observed at both application sites of the 25% group persisting for a total of 2 days. The result obtained were the corresponding stimulation index (SI) with 0.9, 1.1 and 1.6, respectively. Based on this test results the test substance was found to be a non-sensitizer.

EC416-640-2:
The substance was tested in an OECD Guideline 406 (Skin Sensitisation) test. The test substance was applied to guinea pig skin at concentrations of 25% and 50% in water. No skin reactions were noted at the challenge sitesat the 24 and 48-hour observations. The test material produced a 0% (0/10) sensitisation rate

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the category members are not considered to be classified for skin sensitisation under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

 

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the category members are not considered to be classified for skin sensitisation under Regulation (EC) No. 1272/2008.