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Glimepiride

Summary

Persistence. Glimepiride is potentially persistent.
Bioaccumulation. Glimepiride has low potential for bioaccumulation.
Toxicity. Glimepiride has low acute toxicity.
Risk. See the report from GoodPoint.

 

This summary information about hazard comes from Fass.

Detailed information

Fass environmental information

Fass environmental information for Glimepirid Sandoz (downloaded 2022-03-31). Environmental information for glimepiride is produced by the company Sanofi AB for Amaryl, Amaryl® and Glimepirid Winthrop.

Hazard

Persistence: "Ready degradability: Test showed < 10% degradation in 28 days (protocol ISO9439) ... Glimepiride fails to pass the criteria for ready biodegradability which justifies the phrase “Glimepiride is potentially persistent.”

Bioaccumulation: pH 7 (20°C): log Kow 2.14 (Shake Flask Method at pH 4, 7 and 9).

Acute toxicity: There are data for 3 trophic levels, most sensitive algae (Desmodesmus subspicatus) EC50 610720 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2018. PEC/PNEC = 3,3 * 10-6 which gives the risk insignificant.

Pharmaceuticals residues in the aquatic environment in Sweden

Glimepiride has not been detected (detection limit 10 ng/L) in analysis of untreated or treated wastewater from a large number of wastewater treatment plants in Sweden and abroad. However, concentrations of up to 39 ng/L in purified Swedish wastewater are reported in IVL's national screening from 2010. Glimepiride has been below the detection limit during recent years in the Stockholm area.

Comparison with glibenclamide and repaglinide

Glibenklamid is included in Region Stockholm's table of pharmaceuticals with risk for negative environmental impact according to the environmental program 2017–2021 based, inter alia, on finding of the substance in wild fish at concentrations close to therapeutic concentrations in humans. The risk of glimepiride being accumulated in fish to close therapeutic concentration is approximately equal, and the substances act according to the same mechanism. Studies of effect of glimepiride are insufficient. The environmental risk for repaglinide is estimated to be lower.

References

  1. Fass.se för vårdpersonal.
  2. Provtagningar av läkemedelsrester i vatten, sediment och fisk för Region Stockholm.
  3. UBA, The Umweltbundesamt. Database - Pharmaceuticals in the environment.
  4. IVL Swedish Environmental Research Institute Ltd. Fick J, Lindberg RH, Kaj L, Brorström-Lundén E. Results from the Swedish National Screening Programme 2010. Subreport 3. Pharmaceuticals.
  5. Region Stockholm. Förteckning över miljöbelastande läkemedel inklusive åtgärdsförslag framtagen inom ramen för SLL:s miljöprogram 2017–2021.
  6. Jämförande miljöriskbedömningar av möjliga ersättningssubstanser för substanser på Stockholms läns landstings förteckning över miljöbelastande läkemedelssubstanser 2017–2021.

Author: Health and Medical Care Administration, Region Stockholm