Sorafenib
Summary
Persistence. Sorafenib is considered as very persistent.
Bioaccumulation. Sorafenib has high potential for bioaccumulation.
Toxicity. Sorafenib has very high chronic toxicity.
Risk. The use of sorafenib (sales data Sweden 2015) has been considered to result in low environmental risk.
Sorafenib is considered as vP and vB. This summary information comes from assessment report and fass.se.
Detailed information
Assessment report
Assessment report for assessment report for Nexavar (sorafenib) 25 April 2014 EMA/CHMP/220738/2014.
Hazard
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."
Risk
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).
Hazard
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.
Risk
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