Hazard 3 P 0 B 0 T 3 Risk Low
The T-value in the score for hazard refers to chronic toxicity. Underlying data for P, B and T are from assessment report, se below. Risk comes from Fass.se, see below.
Assessment report for Faslodex (fulvestrant) 12 October 2017 EMA/53381/2018 and 29 May 2017 EMA/490887/2017.
Persistence: "DT50, sediment = 23-29d (20°C). DT50, sediment = 41d (12°C). DT50, whole system < 14d (20°C) % shifting to sediment > 10%. Comment: "Not persistent."
Bioaccumulation: Log Kow (ph 7) = 7.67. "The octanol-water partition coefficient, Log Pow, is > 4.5, however the measured assessment of bioaccumulation potential in fish, BCF <357, demonstrates that fulvestrant is not bioaccumulative."
Chronic toxicity: There are data for 3 trophic levels, lowest NOEC for crustacean (D. magna) 0.78 microg/L.
The risk, PEC/PNEC, calculated from data in the assessment report from a European perspective:
Phase IIB refined PECSW = 0.0037 microg/L.
PNEC = Lowest NOEC, 0,78 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 0.078 microg/L.
PEC/PNEC = 0.0474 which gives the risk insignificant.
Fass environmental information
Fass environmental information for Faslodex (downloaded 2018-07-12).
Persistence: "DT50 = <14 days (Total System)."
Bioaccumulation: Log P = 7.67. "Bioconcentration (Whole Body-Based on Total Measured Radioactivity) steady state = 338, Kinetic BCF = 357."
Chronic toxicity: "Long-term tests have been undertaken for species from three trophic levels, based on internationally accepted guidelines." Lowest NOEC for fish (Pimephales promelas) 0.0057 microg/L.
PEC/PNEC is based on sales data in Sweden in year 2014. PEC/PNEC = 0.50 which gives the risk low.
Author: Health and Medical Care Administration, Region Stockholm