4,4'-[1,3-phenylenebis(azo)]bisbenzene-1,3-diamine

Endpoint summary

Key value for chemical safety assessment

Bioaccumulation potential:

no bioaccumulation potential

Additional information

Solvent brown 41 is a brown organic solid that shows very low vapour pressure, it is considered insoluble in water (< <22 mg/l at 25°C experimentally, ca. 0.018 mg/l by estimation) and has an estimated Log Kow of 2.26. All this information suggests a good potential for absorption being a substance lipophilic with a molecular weight smaller than the cut-off value of 500. However, no adverse local or systemic effect were observed after inhalatory application of Solvent Brown 41. 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. Neverthless, mortality after single oral application of analogue substance 1 was observed at doses > 2000 mg/kg and systemic adverse effects were observed after repeated oral exposure only at the highest dose level (240 mg/kg bw /day) of the analogue substance 2, tested following OECD 422. Some adverse effect that, however, do not trigger classification, were recorded in the same study for the developmental toxicity endpoint (OECD 422) ,on the basis of decreased number of females bearing live pups, increased prenatal mortality and decreased mean litter weight, setting the corresponding NOAEL to 60 mg/kg bw /day.

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