Hazard 6 P 0 B 3 T 3 Risk High
The T-value in the score for hazard refers to chronic toxicity. Underlying data for P, B and T comes from assessment report för Zytiga (abirateron), see below. The risk comes from Fass.se.
Assessment report for Zytiga (abiraterone) 12 October 2017, EMA/816845/2017.
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 Kow = 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."
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 for Zytiga (abirateron) (downloaded 2018-06-29).
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 Dow > 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.
"According to the established EU-criteria Abiraterone acetate should not be regarded as a PBT substance."
PEC/PNEC is based on sales data in Sweden in year 2016. PEC/PNEC = 11,7 which gives the risk high.
Author: Health and Medical Care Administration, Region Stockholm