Diammonio(ethyl)[4-[[4-[ethyl(3-sulphonatobenzyl)amino]phenyl](2-sulphonatophenyl)methylene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium

Endpoint summary

Description of key information

Not sensitiser

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

The following reported data were obtained for Similar Substance 1. It is expected that the Target substance will present similar effects of skin sensitisation. Justification for Read Across is given in Section 13 of IUCLID.

A study for skin sensitization was performed on Similar Substance 1. At that time, the OECD testing guideline was not yet available. Anyway the study procedure follows the experimental design of the Local lymph node assay (OECD 429). The study was not performed under GLP, but it was performed at a professional Contract Research Organization that routinely works under GLP. The quality of the experimental performance is therefore considered acceptable. The study was performed with doses up to 25% with no specific justification. However, from experience, 25% is a top dose very often used for solid substances as higher concentrations cannot technically be achieved. The high dose is therefore considered to be sufficiently high. In addition, there is no trend towards an increase of the SI below the cut-off level, so that the result "non sensitizing" is of high certainty. The ear thickness was not increased either. In conclusion the substance is considered non sensitiser.

Another Study is reported to support the information coming from the key study. The results are summarised in SCCNFP COLIPA (2004). A Local Lymph Node Assay (OECD 429) on mice (CBA J female) has been performed using a dose 0.5 -4% of Similar Substance 1 in DMSO and in acetone/aqua (1:1) i.e. AA mixed with olive oil. On days 0, 1 and 2 the animals received 25 μl of one of the test preparations or vehicle on the dorsal surface of each ear. On day 5 all mice received intravenous injection of tritium labelled thymidine in phosphate buffered saline, and 5 hours later they were killed humanely and the draining auricular lymph nodes were removed. Single cell suspensions were prepared for each animal, appropriately treated and measured by liquid scintillation counting. The stimulation indices were less than 3 at all tested concentrations, hence an EC3 value could not be calculated, and the test substance was classified as non-sensitizing in the vehicles tested.

Overall, the data reliably shows that the substance is not a skin sensitizer in mice.

References:

- SCCNFP 2004. Opinion of the Sientific Committee on Cosmetic Products and Non-food Products intended for Consumers. Acid Blue 9 COLIPA n° C40.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008) for Category 1, a stimulation index (SI) of three or more is considered a positive response in the local lymph node assay. For all the concentrations tested in the key study and in the supporting study, the SI values are lower than three. According to the CLP Regulation (EC n.1272/2008) no classification is required for the substance as a skin sensitiser.