Registration Dossier

Administrative data

Description of key information

Sepisol Fast Blue 85219 has been classified as acute toxicity category 4 with a LD 50 experimentally determined between 2000 and 300 mg/kg in rat.

Some concerns have been raised in regards to the toxicity per inhalation because of the relatively fine granulometry.

It was not reasonably possible to conclude but precautionnary measures should be taken so as to avoid exposition.

Key value for chemical safety assessment

Additional information

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

90% of the particles 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, Sepisol Fast Blue 85219 has been classified as acute toxicity category 4 according to the CLP regulation.

Sepisol fast blue 85219 also shows a high Kow value which would suggest a good bioavaibilitity following a penetration through the alveoli. However the substance is a powder and is practically insoluble. As a result, it is unlikey that the substance will be solubilized. In this case the substance would remain as a particle state and would not be absorbed.

Moreover the vehicle (olive oil) used in the acute toxicity per os is not appropriate for this way of exposure.This would imply a change in the level of bioavailability.

As a result of the previous reasons, Sepisol fast blue 85219 is not expected to be also toxic per inhalation. The precautionary principle would recommend the warning of this possible effect inside safety documents.

Justification for classification or non-classification