Pantoprazole
Summary
Persistence. Pantoprazole is potentially persistent.
Bioaccumulation. Pantoprazole has low potential for bioaccumulation.
Toxicity. Pantoprazole has moderate acute toxicity.
Risk. Comparative assessment of environmental risk associated with the use of acid secretion inhibitors esomeprazole, lansoprazole, omeprazole, pantoprazole, and ranitidine from a Swedish perspective. Thus, the environmental risk is considered negligible for all substances studied in Swedish watercourses.
Underlying data for P, B and T are from Fass. The risk is from the report by Goodpoint.
Detailed information
Assessment report
Assessment report for Somac Control (pantoprazole) 8 May 2009, Doc.Ref.: EMEA/374377/2009.
"For the environmental risk assessment, the applicant has conducted the following studies: Ready biodegradability (OECD 301 D), Aerobic Transformation in Water (OECD 308), Respiration Inhibition Test (OECD 209), Daphnia immobilisation (OECD 202), Daphnia reproduction Test (OECD 211), Acute Toxicity to Fish (OECD 203), Fish Early Life Stage Toxicity Test (OECD 210) and Algae Growth Inhibition Test (OECD 201). In addition, the applicant has initiated a sediment-water chironomid toxicity test using spiked Sediment (OECD 218). The final report of this study will be provided as post-approval commitment together with a discussion on the impact of this data on the environmental risk assessment." No such information has been found on EMA's website (2019-10-25).
Fass environmental information
Fass environmental information for Pantoloc (pantoprazole) from Takeda Pharma (downloaded 2019-10-25).
Hazard
Persistence:"Test results from "closed bottle test" (guideline 301 D) shows that the biological degradation is 5,5% in 28 days. Pantoprazole is potentially persistent."
Bioaccumulation: Log Kow (pH 7.4) = 2.05 (method unknown).
Acute toxicity: There are data for 3 trophic levels, most sensitive algae (Scenedesmus subspicatus) 26 mg/L.
Risk
PPEC/PNEC is based on sales data in Sweden in year 2018. PEC/PNEC = 0.002588 which gives the risk insignificant.
Report Goodpoint 2019
Comparative assessment of environmental risk associated with the use of acid secretion inhibitors esomeprazole, lansoprazole, omeprazole, pantoprazole, and ranitidine from a Swedish perspective (Report Goodpoint 2019).
Regardless of whether a worst-case exposure scenario (PEC) or measured concentrations in the environment/wastewater (below detection limits except for ranitidine) is considered, the margins compared to both CEC values (indicating potential interaction with targets in aquatic organisms, particularly fish) and established toxicity thresholds in aquatic species are very large (less than 0.001 for all substances). Thus, the environmental risk is considered negligible for all substances studied in Swedish watercourses. No substitutions are therefore recommended from an environmental perspective.
References
- European Medicines Agency. European public assessment report (EPAR). Somac Control (pantoprazole) 8 May 2009, Doc.Ref.: EMEA/374377/2009.
- Fass för vårdpersonal.
- Goopoint. Jämförande bedömning av miljörisk vid användning av syrasekretionshämmarna esomeprazol, lansoprazol, omeprazol, pantoprazol samt ranitidin. Goodpoint; 2019-07-01.
Author: Health and Medical Care Administration, Region Stockholm