Sorafenib
Summary
Persistence. Sorafenib is considered as very persistent.
Bioaccumulation. Sorafenib has high potential for bioaccumulation.
Toxicity. Sorafenib has very high chronic toxicity.
Risk. Particularly hazardous environmental properties
Sorafenib is considered as vP and vB. According to the established EU criteria, the substance should be regarded as a PBT/vPvB substance. 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) from Bayer (retrieved on 2026-07-07).
Hazard
Persistence: Sorafenib tosylate was not readily biodegradable and showed 0% biodegradation over 28 days in an OECD 301 study. In an OECD 308 study, the substance was rapidly transferred from water to sediment, with a half-life in water of 0.5–0.6 days. As the half-life in the total system was considered to exceed 120 days, sorafenib tosylate should be regarded as a PBT/vPvB substance according to stablished EU criteria.
Bioaccumulation: Sorafenib tosylate has the potential to bioaccumulate in aquatic organisms. The log D at pH 7 was 3.7 and the bioconcentration factor (BCF) in fish was 5,300–7,250. After temperature correction to 12 °C, the BCF was 17,032–23,298, indicating that the substance meets the bioaccumulation criterion for PBT/vPvB classification according to established EU criteria.
Chronic toxicity: There is NOEC/EC10 for 3 trophic levels, lowest NOEC/EC10 (EC10/28d; mortality) for fish 0.17 microg/L.
PBT/vPvB assessment
Sorafenib tosylate meets the EU criteria for classification as a PBT/vPvB substance. The substance is considered persistent because it is not readily biodegradable, bioaccumulative with a BCF of 17,032–23,298, and toxic to aquatic organisms with a lowest NOEC value of 0.17 microg/L.
Risk
Particularly hazardous environmental properties
Author: Health and Medical Care Administration, Region Stockholm