Hazard 3 P 3 B 0 T 0 Risk Insignificant
The T-value in the score for hazard refers to chronic toxicity. Underlying data for P, B and T comes from assessment report. Risk comes from Fass.se.
Assessment report for Eliquis (apixaban) 26 June 2014, EMA/478338/2014.
Bioaccumulation: log Kow 1.2. Conclusion: not B.
Chronic toxicity: There is NOEC for 3 trophic levels, lowest NOEC for algae (Pseudokirchneriella subcapitata) 3 600 microg/L.
The risk, PEC/PNEC, calculated from data in the assessment report from a European perspective:
PEC = 0.175 microg/L
PNEC = Lowest NOEC, 3 600 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 360 microg/L
PEC/PNEC = 0.000486
Fass environmental information for Eliquis (apixaban) (downloaded 2019-10-14).
Persistence: "The total system half-life of apixaban (based on dissipation rates) for sediment 1 and 2 was 100 and 182 days, respectively."
Bioaccumulation: "Log Do/w = 1.20 at approximately neutral pH at 21°C (apixaban is non-ionizable)."
Chronic toxicity: There is NOEC for 3 trophic levels, lowest NOEC for algae (Pseudokirchneriella subcapitata) (OECD 201) NOEC 72 h (growth rate/biomass) = 3.6 mg/L.
PEC/PNEC is based on sales data in Sweden in year 2017. PEC/PNEC = 0.000117 which gives the risk insignificant.
Author: Health and Medical Care Administration, Region Stockholm