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Ezetimibe

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 Ezetrol (ezetimib) (downloaded 2018-10-30).

Hazard

Persistence OECD 308: "DT50 (total system) = 11 - 23 days. [---] The DT50 for the total system is < 32 days with > 15% parent compound remaining at the end of the study therefore the phrase, “Ezetimibe is slowly degraded in the environment” is thus chosen."

Bioaccumulation: "Measured BCF values were 69 (low concentration) and 137 (high concentration) in a 97 day study with bluegill sunfish."

Chronic toxicity: There is NOEC for 3 trophic levels, lowest NOEC for fish (Pimephales promelas) 50 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2015. PEC/PNEC = 0.002 which gives the risk insignificant.

Pharmaceutical analyses of water in Stockholms region 2017

Ezetimib has not been detected in treated wastewater, surface water and drinking water at measurements 2017.

National measurements of drug residues in water in Sweden

Ezetimibe has been detected in water for wastewater treatment plants. The reduction rate varied between more than 11 and 79%.

The article Predicted critical environmental concentrations for 500 pharmaceuticals

Critical effect concentration (CEC) for ezetimib is 151 ng/L. Log P is set to 3.9.

Author: The Pharmaceutical unit of Region Stockholm