Flumazenil
Summary
Persistence. It cannot be excluded that flumazenil is persistent, as data are lacking.
Bioaccumulation. Flumazenil has low potential for bioaccumulation.
Toxicity. Flumazenil may have low acute toxicity. For further details, see the section titled Detailed Information for Flumazenil Fresenius Kabi.
Risk. The use of flumazenil (Swedish sales data 2021) has been assessed to pose an insignificant risk to the environment. For further details, see the section titled Detailed Information for Flumazenil Fresenius Kabi.
This summary information comes from fass.se.
Detailed information
Comment on Fass environmental information
Flumazenil has different classifications on fass.se. According to Lif (the trade association for the research-based pharmaceutical industry in Sweden) the various pharmaceutical companies compile environmental information for their active substances based on internal studies and published data. Based on data, which may thus differ between different pharmaceutical companies, the companies assess the environmental risk with guidance from “Environmental classification of pharmaceuticals at www.fass.se – Guidance for pharmaceutical companies 2012”. The Swedish Environmental Institute (IVL) reviews the assessment but does not have the task of coordinating/harmonizing environmental information from different pharmaceutical companies for the same active substance.
Fass environmental information Flumazenil Fresenius Kabi
Fass environmental information for Flumazenil Fresenius Kabi (retrieved on 2025-07-01).
Hazard
Persistence: No data.
Bioaccumulation: Log P = 1.54.
Toxicity: There are data for 1 trophic level, crustacean > 500 mg/L. Comment: Values reported as greater than are not according to the guidelines. The actual value may be lower.
Risk
PEC = 0.00000116 μg/L. "Since PEC/PNEC ≤ 0.1, which justifies the phrase Use of Flumazenil has been considered to result in insignificant environmental risk." The calculation of the PEC/PNEC value is not provided.
Fass environmental information Flumazenil hameln
Fass environmental information for Flumazenil hameln from hameln pharma (retrieved on 2025-07-01).
Hazard
Persistence: No data.
Bioaccumulation: Log Pow = 1.9 (experimental by unknown method).
Toxicity: No data.
Risk
Risk of environmental impact of flumazenil cannot be excluded, since no ecotoxicity data are available.
References
Author: Health and Medical Care Administration, Region Stockholm