Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

Key value for chemical safety assessment

Additional information

Basic Brown 1 acetate is a black organic solid, usually put on the market in acetic acid aqueous solution. It shows very low vapour pressure, it is insoluble in water and has an estimated Log Kow of 3.41. All this information suggests a good potential for absorption being a lipophilic substance ; however the substance has a molecular weight that counterbalance this property. No adverse local or systemic effects were observed after dermal application suggesting no percutaneous absorption. The very low water solubility would be moreover in favour of a null absorption after inhalation. The only expected absorption of the substance is therefore supposed to happen through the GI tract, in particular at the intestine level where the substance is most likely in its neutral form (Solvent Brown 41). The only systemic adverse effects were observed after repeated oral exposure at the highest dose level, as the mortality after single oral application was observed at doses > 3000 mg/kg.

No mutagenic effects (gene mutation and chromosome aberration) were observed after in vivo studies performed by oral gavage and injection to rats even though the substance was systemically present.

A more complete description of the toxicokinetic behaviour is reported in the attached document