Midazolam
Summary
Persistence. The potential for persistence of midazolam cannot be excluded, due to lack of data.
Bioaccumulation. Midazolam has high potential for bioaccumulation.
Toxicity. It cannot be excluded that midazolam is toxic, due to the lack of data.
Risk. Risk of environmental impact of midazolam cannot be excluded, since no ecotoxicity data are available.
This summary information comes from Fass.
Detailed information
Assessment report
Assessment report for Buccolam (midazolam), EMA/662938/2011, Committee for Medicinal Products for Human Use (CHMP).
Hazard
Persistence: No data.
Bioaccumulation: pH 7 Log Kow = 3.30, pH 8 Log Kow = 3.34 och pH 9 Log Kow = 3.34. No Potential for PBT (Log Kow values <4.5).
Toxicity: No data.
Risk
Midazolam PECsurfacewater value is below the action limit of 0.01μg/L and is not a PBT substance as log KOW does not exceed 4.5. Therefore no Phase II ERA is required.
Fass environmental information
Fass environmental information for Midazolam Panpharma from Panpharma Nordic (downloaded 2023-02-06).
Hazard
Persistence: No data.
Bioaccumulation: Log P = 4.33 at physiological (estimated by unknown method). Since log P ≥ 4 at 7, midazolam has high potential for bioaccumulation.
Toxicity: No data.
Risk
Risk of environmental impact of midazolam cannot be excluded, since no ecotoxicity data are available.
Author: Health and Medical Care Administration, Region Stockholm