Miljöpåverkan
Fosfomycin
Miljörisk:
Risk för miljöpåverkan av fosfomycin kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att fosfomycin är persistent, då data saknas.
Bioackumulering:
Fosfomycin har låg potential att bioackumuleras.
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Detaljerad miljöinformation
Predicted Eniviromental Concentration (PEC)
PEC is calculated according to the following formula:
PEC(μg/L) = (A*109*(100-R))/(365*P*V*D*100) = 1.37*10-6*A(100-R)
PEC= 0.000678 μg/L
A=4,9504 (total amount API of fosfomycinnatrium in Sweden year 2022, data from IQVIA) (Ref.1)
R=removal rate=0% (no data available)
P=number of inhabitants in Sweden
V (L/day)=volume of wastewater per capita and day=200 (ECHA default) (Ref.2)
D= factor for dilution of wastewater by surface water flow=10 (ECHA default) (Ref.2)
Predicted No Effect Concentration (PNEC)
Data not available
Environmental risk classification
Risk of environmental impact of fosfomycin cannot be excluded, since there is not sufficient ecotoxicity data available.
Degradation
No data available.
Bioaccumulation
A derived log Kow of -1,23 (Ref.3) indicates that Fosfomycin has low potential for bioaccumulation.
Log Kow <4 which justifies use of the phrase “Fosfomcyin has low potential for bioaccumulation”.
References
1. Sales data in kg from IQVIA 2022
2. Committee for Medicinal Product for Human Use (CHMP) Guideline on the Enviromental Risk Assessment of Medicinal Product for Human Use (EMEA/CHMP/SWP/4447/00, June 2006).
3. Enviromental Risk Assessment Fosfomcyin, Internal document.