Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

- The substance is not metabolised by rat or human microsomal enzymes;

- Patent blue V has low absorption and limited systemic availability;

- It is mainly exctreted in faeces.

Key value for chemical safety assessment

Additional information

An in vitro study was performed in 2011 (Guerbet/Eurofins, Study of Patent Blue V metabolisation on human and rat microsome, 88 pages, February 16, 2011) in order to measure the metabolism of E131 Patent blue V in hepatic microsomes from rats and humans: the substance is not metabolised at concentrations of 1 to 100 μM.

Several in vivo studies demonstrated that the substance is not metabolised and completely excreted in 72 hours with no accumulation potential.