Registration Dossier

Administrative data

Description of key information

Under experiemental conditions Sepisol Fast Blue 85219 has been found to be irritating for the eyes and is also expected to be a respiratory irritant.

Sepisol Fast blue 85219 was not found to be an irritant for the skin of rabbits.

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: irritating

Effects on respiratory irritation: irritating

Justification for classification or non-classification

The substance Sepisol fast blue 85219 is a powder exhibiting a fine granulometry.

90% of the particles size are below 268,5 µm; 50% below 69 µm and 10% below 8.7 µm. The size of 93.5 % of the total sample is less than 125 µm and most probably the MMAD is below 100 µm. It is then expected that this powder will be present all along the respiratory tract and will penetrate deeply in the lungs.

Following a in vivo assay, the substance of concern has been classified as irritant category 2 for the eyes 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 blue 85219 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.