Abiraterone

Assessment report

Assessment report for Zytiga (abiraterone) 12 October 2017, EMA/816845/2017.

Hazard

Persistence: "DT50, freshwater = 2.3 days, DT50, sediment = ND, DT50, whole system = 4.9 and 3.3 days % shifting to sediment = sediment-bound residue 28.2% and 22.1%."

Bioaccumulation: log K_ow = 5,12. BCF = "903 (for low conc, 0.13 μg/L), 931 (for high conc, 1.3 μg/L)." Conclusion: B.

Chronic toxicity: There is NOEC for 3 trophic levels, lowest NOEC for fish (fathead minnow partial life cycle) 0.013 microg/L. Conclusion: T.

PBT-statement: "The compound is considered as T."

Risk

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

PECsurfacewater = 0.004 microg/L

PNEC = Lowest NOEC 0.013 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 0.0013 microg/L

PEC/PNEC = 3.077

Fass environmental information

Fass environmental information for Zytiga (abirateron) (downloaded 2018-06-29).

Hazard

Persistence: "Taunton River Aerobic DT50 (Days) Total system = 4.9, Weweantic River Aerobic DT50 (Days) Total system = 3.3. Abiraterone acetate is degraded in the environment."

Bioaccumulation: Log D_ow > 6.20 (pH = 6.10), "BCFlow dose = 625, BCFhigh dose = 576. Abiraterone acetate has high potential for bioaccumulation."

Kronisk toxicitet: There is NOEC for 3 trophic levels, lowest NOEC for fish (fathead minnow Pimephales promelas 119 days) = 0.013 microg/L.

Conclusion for PBT-assessment

"According to the established EU-criteria Abiraterone acetate should not be regarded as a PBT substance."

Risk

PEC/PNEC is based on sales data in Sweden in year 2016. PEC/PNEC = 11,7 which gives the risk high.