Bis and tris and tetra (4-{bis[4-(dimethylamino)phenyl]methylene}-N,N-dimethylcyclohexa-2,5-dien-1-iminium) [12,21-dihydro-29H,31H-phthalocyanine-bis and tris and tetrasulfonato-k4N29,N30,N31,N32]cuprate

Endpoint summary

Description of key information

Under experimental conditions and based on a read-across with a very similar substance, Sepisol Fast Violet 3B has been found to be highly irritating for the eyes (with irreversible damage) and is also expected to be a respiratory irritant.
Sepisol Fast Violet 3B was not found to be an irritant for the skin of rabbits (also based on a read-across).

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

Effects on eye irritation: highly irritating

Effects on respiratory irritation: irritating

Justification for classification or non-classification

Irritation of the respiratory tract :

The substance Sepisol Fast Violet 3B is a powder exhibiting a fine granulometry.

In the key study, the particles size distribution has been determined by laser diffraction. 90% of the particles size stands below 233.5 µm; 50% below 77.39 µm and 10% below 11.1 µm. In the supporting study, the size of 82.8 % of the total sample is less than 125 µm. Thus the MMAD is most probably below 100 µm.

It is then expected that this powder will be present all along the respiratory tract, however, only a small fraction (~10%) will penetrate deeply in the lungs.

Following an in vivo assay used for the read accross, the substance of concern as been classified as eye damage category 1 according to the CLP regulation. The effect did not seem to be caused by a mechanical irritation. As a result of the previous reasons Sepisol fast Violet 3B is foreseen to be a possible irritant for the mucous membrane lining the respiratory tract. Therefore it has been classified accordingly: STOT cat 3 - inhalation; H 335.

Skin irritation properties:

An Episkin test method was run on Sepisol Fast Violet 3B but considered as incompatible with the test material. To avoid an unnecessary in vivo test on rabbits'skin, a read-across with a very identical substance has been performed. This read-across leads us to the conclusion that Sepisol Fast Violet 3B was not expected to be an irritant to the skin (according to CLP criteria).

For the eyes irritating properties:

A Bovine Corneal Opacity and Permeability Test Method was performed on Sepisol fast Violet 3B. Despite the fact that the study was well-conducted, the result was inconclusive. On the basis of the results obtained for each time of contact, a corneal score was calculated and the test element was classified moderately irritant. However, corneas from the treatment group were coloured in blue after 30 min of contact. Since opacity can be due to the corneal blue coloration and not due to a real corneal opacity, the result is uncertain. Futhermore, the laboratory does not have any recoil on this category of substances (i.e. organic colorant) and no comparaison with an appropriate database was performed. So the accuracy of BCOP assay and its applicability domain for this category of substance cannot be assessed and the results remain uncertain.

To avoid an unnecessary in vivo test on rabbits'eyes, a read-across with a closely identical substance has been performed. This read-across leads to the conclusion that Sepisol Fast Violet 3B was to be considered as an irreversible eye irritant (eye damage category 1 according to CLP criteria).

Comment: The BCOP assay was found not be appropriatde for this category of organic dyes as it apparently underestimates the eye irritancy potential of the Sepisol Fast Violet 3B.