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Esomeprazole

Hazard 1 P 0 B 0 T 1 Risk Insignificant

Information

The T-value in the score for hazard refers to chronic toxicity. Underlying data for P, B and T comes from assessment report.

Assessment report

Assessment report for Nexium Control (esomeprazole), 27 June 2013, EMA/498929/2013.

Hazard

Persistence: Kd(ads) = 48, "DT50, water = 2.2 to 3.7, DT50, sediment = 3.1 to 6.8 (OECD 308)." According to expert, esomeprazole does not seem to be persistent (Researcher at the Department of Environmental Science and Analytical Chemistry (ACES), Stockholm University 2018-09-05).

Bioaccumulation: log Kow < 4.5.

Chronic toxicity: There is NOEC for 3 trophic levels, lowest NOEC for fish (Pimephales promelas) 1 mg/L.

Risk

The risk, PEC/PNEC, calculated from data in the assessment report from a European perspective:

PEC = 0.1 microg/L.

PNEC = Lowest NOEC, 1 000 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 100 microg/L.

PEC/PNEC = 0.001 vwhich gives the risk insignificant.

Fass environmental information

Fass environmental information for Nexium (esomeprazole) (downloade 2018-07-03)

Fara

Persistence: OECD 308: "Radiolabelled test substance was dosed into the overlying water and the subsequent dissipation from the water phase and partitioning and/or degradation in the sediment was observed over a 100 day test period, leaving less than 7 % of the parent substance in the sediment-water system. In both the high organic matter (HOM) and low organic matter (LOM) test vessels,esomeprazol was observed to be rapidly dissipated from the water phase and total system, with a half-life <14 days, respectively)." "The Kd(ads) was 48. Therefore, the substance has been assigned the phrase: “Esomeprazole is slowly degraded in the environment”."

Bioaccumulation: Log Dow < 4.

Chronic toxicity: here is NOEC for 3 trophic levels, lowest NOEC for fish (Pimephales promelas) 1 mg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2014. PEC/PNEC = 0.0085 vwhich gives the risk insignificant.

Author: The Pharmaceutical unit of Region Stockholm