Fusidic acid
Summary
Persistence. It cannot be excluded that fusidic acid is persistent, due to the lack of data.
Bioaccumulation. Fusidic acid has low potential for bioaccumulation.
Toxicity. It cannot be excluded that fusidic acid is toxic, due to the lack of data.
Risk. Risk of environmental impact of fusidic acid cannot be excluded, due to the lack of environmental toxicity data.
Detailed information
Fass environmental information
Fass environmental information for Fucithalmic (fusidic acid) from Amdipharm (downloaded 2022-09-23). The environmental information for fusidic acid (anhydrous) is produced by the company Abcur for Fucithalmic.
Hazard
Persistence: No data.
Bioaccumulation: Log KOW, sodium fusidate = 2.6 at pH 7.4 (LEO Pharma A/S ...). Test method unknown. As Log KOW < 4 the following phrase applies: “Fusidic acid has low potential for bioaccumulation”.
Toxicity: No data.
Risk
PEC = 0,0018998 μg/L. "According to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of anhydrous fucidic acid is unlikely to represent a risk for the environment, because the predicted environmental concentration (PEC) is below the action limit 0,01 μg/L." The PEC values in the manufacturers' assessment reports are based on the estimated use of the medicinal product to which the assessment report relates, not all medicinal products containing the same active substance.
References
Author: Health and Medical Care Administration, Region Stockholm