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Fulvestrant

Hazard 3 P 0 B 0 T 3 Risk Low

Information

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

Assessment report for Faslodex (fulvestrant) 12 October 2017 EMA/53381/2018 and 29 May 2017 EMA/490887/2017.

Hazard

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.

Risk

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).

Hazard

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.

Risk

PEC/PNEC is based on sales data in Sweden in year 2014. PEC/PNEC = 0.50 which gives the risk low.

Author: The Pharmaceutical unit of Region Stockholm