Hazard 9 P 3 B 3 T 3 Risk See below
The T-value in the score for hazard refers to chronic toxicity. Underlying data for P, B and T comes from assessment report, see below. "The compound is considered as vP and vB."
Assessment report for assessment report for Nexavar (sorafenib) 25 April 2014 EMA/CHMP/220738/2014.
Persistence: "There was no degradation after 28 days. DT50 (transformation in soil) - 187 days." Conclusion: vP.
Bioaccumulation: BCF = 7 250 "ratio fish/water concentration at the end of exposure." Conclusion: vB.
Chronic toxicity: There is NOEC /EC10 for 3 trophic levels, lowest NOEC /EC10 for fish 0,17 microg/L.
"The compound is considered as vP and vB."
The risk, PEC/PNEC, calculated from data in the assessment report from a European perspective:
PEC = 0.0378 microg/L
PNEC = Lowest NOEC/EC10: 0.17 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 0.017 mikrog/L
PEC/PNEC = 2.224
Fass environmental information
Fass environmental information for Nexavar (sorafenib) (downloaded 2018-06-27).
Persistence: "Sorafenib showed no degradation in a water-sediment system (OECD 308). Sorafenib is potentially persistent."
Bioaccumulation: "The BCFs was determined with 5300 for the higher concentration and >7300 for the lower concentration, where no steady-state was reached."
Chronic toxicity: here is NOEC /EC10 for 3 trophic levels, lowest NOEC /EC10 (EC10/28d; mortality) for fish 0.17 microg/L.
PEC/PNEC is based on sales data in Sweden in year 2015. PEC/PNEC = 0.2 which gives the environmental risk low. As stated above: "The compound is considered as vP and vB."
Author: Health and Medical Care Administration, Region Stockholm