Vortioxetine
Summary
Hazard 9 P 3 B 3 T 3 Risk See below
The T-value in the score for hazard refers to chronic toxicity.
According to EU established criteria, vortioxetine is considered a PBT/vPvB substance. The toxicity of aquatic organisms is very high, the substance is capable of bioaccumulation and degradation is slowly in the environment.
Assessment report
Assessment report for Brintellix (vortioxetine) 24 October 2013, EMA/699150/2013.
Hazard
Persistence: OECD 308: "DT50, water = 2.1-3.7 days, DT50, sediment = not calculable, DT50, whole system = 7.2-50.1 days % shifting to sediment (d100) = 90.7% / 86.7%"
Bioaccumulation: BCF = 2 032-2 121
Chronic toxicity: There is NOEC for 3 trophic levels, lowest NOEC for fish 0.091 microg/L.
Risk
Th risk, PEC/PNEC, from assessment report is from a European perspective. "Free base; risk for fish PEC/PNEC > 1", i.e. moderate.
"The compound is considered as PBT. [---] The available data do not allow to conclude definitively on the potential risk of vortioxetine to the environment. The CHMP recommends further investigation." No further information has been found.
Fass environmental information
Environmental information is missing on fass.se (2018-06-14). It is voluntary for manufacturers to provide information about environmental impact on fass.se.
Author: Health and Medical Care Administration, Region Stockholm