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Bicalutamide

Hazard 5 P 3 B 0 T 2 Risk Insignificant

Information

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

Fass environmental information

Fass environmental information for Casodex (bicalutamide) (downloaded 2018-10-30).

Hazard

Persistence OECD 308: "Although there was evidence of both dissipation and degradation of bicalutamide from the overlying waters, there was little evidence of degradation in the sediment. The results indicate that bicalutamide is unlikely to persist in the aqueous phase, however once adsorbed to the sediment phase bicalutamide is unlikely to undergo degradation and is expected to remain unchanged. As such, although the total system DT50 is <120 days, a precautionary approach has been taken and the substance has been assigned the risk phrase “Bicalutamide is potentially persistent”.

Bioaccumulation: Log P = < 4 at pH 7.

Chronic toxicity: There is NOEC for 3 trophic levels, lowest NOEC for fish (Pimephales promelas) 10 microg/L.

Risk

PPEC/PNEC is based on sales data in Sweden in year 2015. PEC/PNEC = 0.098 which gives the risk insignificant.

The article Predicted critical environmental concentrations for 500 pharmaceuticals

The Critical effect concentration (CEC) of bicalutamide is 239 446 ng/L.

Author: Health and Medical Care Administration, Region Stockholm