Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

The physico-chemical data (molecular mass and log Pow) indicate a very low probability of the substance for absorption. The theoretical conclusion is supported by the absence of systemic toxic effects in the available animal studies.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

Based on available toxicity studies, it is concluded that E-200 is non-toxic by exposure via oral and dermal route and it is non-irritant and non-sensitizer to skin.

Absorption on the inhalation route

The chemical does not enter into human body via inhalation due to its high boiling point (> 375 ºC), very low vapour pressure (< 1.33 x 10-8Pa at 20 ºC) and large particle size (D50: 255.545 µm). As over 10% of the powder particles have a particle diameter <100 µm there is a potential for dust particles to reach the thoracic and alveolar region of humans. However, the majority of them will be trapped in the nasal cavity, trachea and bronchia and subsequently transported by ciliary cells of the respiratory epithelium to the oesophagus.

 

Absorption on the dermal or oral route

The "rule of five" bioavailability criteria by Lipinski et al (2001) indicate that the components of the substance are not bioavailable because the log Pow are >5.0 and the molecular mass are >500 Dalton.