Registration Dossier
Registration Dossier
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EC number: 700-615-0 | CAS number: -
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Justification of the selected rate for oral, dermal and inhalation routes.
Key value for chemical safety assessment
- Absorption rate - oral (%):
- 50
- Absorption rate - dermal (%):
- 10
- Absorption rate - inhalation (%):
- 50
Additional information
Oral absorption rate:
Given the extremely low water solubility and high partition coefficient characteristics, together with the high molecular weight (> 1000), Sepisol Fast Violet 3B is expected to not be readily absorded after ingestion. However, a conservative oral rate of 50% is selected.
Inhalation absorption rate:
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.
Furthermore, as stated in the guidance document chapter R.7.c, given the extremely low water solubility and high partition coefficient, powder depositing in the nasopharyngeal region can be coughed or sneezed out of the body or swallowed. In case of deeper deposit in the tracheo-bronchial region, clearance from the lungs by the mucocilliary mechanism followed by swallowing will allow the elimination of the particules from the respiratory tract. For the small fraction of ~10% that could penetrate deeply in the lungs, would mainly be engulfed by alveolar macrophages and be either translocated to the ciliated airways or carried into the pulmonary interstitium and lymphoid tissues. Therefore, an absorption rate of 50% is selected.
Dermal absorption rate:
Given the extremely low water solubility and high partition coefficient characteristics (> 4), together with the high molecular weight (> 1000), Sepisol Fast Violet 3B is expected to have a limited extent cross the skin. According to the guidance document chapter R.7.c, a value of 10% skin absorption is chosen.
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