Dasatinib

Summary

Hazard 5 P 3 B 0 T 2 Risk Low

The T-value in the score for hazard refers to acute/chronic toxicity. Underlying data for P, B, T and risk are from assessment report.

Assessment report

Assessment report forSprycel (dasatinib) 26 April 2018, EMA/CHMP/302652/2018.

Hazard

Persistence: "Dasatinib was not readily biodegradable at 28 days. OECD 308: DT50, whole system =79.7-131 days % shifting to sediment = 27.1-56.3."

Bioaccumulation OECD 107: pH 5 – 1.85, pH 7,8 – 3.56, pH 9 - 3.56. Conclusion: not B.

Chronic toxicity: There are data for 3 trophic levels, lowest NOEC for fish (Pimephales promelas) 18 microg/L.

Risk

The risk, PEC/PNEC, calculated from data in the assessment report from a European perspective:

PEC = 1.8 microg/L

PNEC = Lowest NOEC, 18 microg/L/10 (Assessment Factor (AF) for 3 chronic studies = 1.8 microg/L

PEC/PNEC = 1, which gives the risk low.

Fass environmental information

Fass environmental information for Sprycel (downloaded 2018-10-25).

Hazard

Persistence OECD 308: "The total system half-life of dasatinib (based on dissipation rates) for sediments 1 and 2 was 79.7 and 131 days, respectively."

Bioaccumulation: "Log K_ow values of 1.85 at pH 5, 3.56 at pH 7.8 and 3.56 at pH 9."

Chronic toxicity: There is NOEC for 3 trophic levels, lowest NOEC for fish (Pimephales promelas) 18 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2015. PEC/PNEC = 0,000444 which gives the risk insignificant.