Miljöpåverkan
Miljöinformationen för furosemid är framtagen av företaget Orifarm Generics AB för Furix Retard, Furix®, Furosemid Copyfarm, Furosemide Claris
Miljörisk:
Användning av furosemid har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning:
Furosemid är potentiellt persistent.
Bioackumulering:
Furosemid har låg potential att bioackumuleras.
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Detaljerad miljöinformation
Environmental Risk Classification
Predicted Environmental 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 = 0.37 µg/L
Where:
A = 2696.87 kg (total sold amount API in Sweden year 2020, data from IQVIA).
R = 0% removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation) = 0 if no data is available.
P = number of inhabitants in Sweden = 1*107
V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (Ref.1)
D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Ref.1)
Predicted No Effect Concentration (PNEC)
Ecotoxicological studies:
Algae (Pseudokirchneriella subcapitata):
EC50 72 h = 142 mg/L (guideline OECD 201) (Ref.2)
Crustacean - Fresh water flea (Daphnia magna):
EC50 48 h = 239 mg/L (guideline OECD 202) (Ref.2)
Fish - Sheepshed minnow (Cyprinodon variegatus variegatus):
LC50 96 h = 497 mg/L (guideline OECD 203) (Ref.2)
PNEC = 142 µg/L (justification of chosen assessment factor)
PNEC (µg/L) = lowest EC50/1000 where 1000 is the assessment factor used. EC50 for Pseudokirchneriella subcapitata has been used as for this calculation since it is the most sensitive of the three tested species.
Environmental risk classification (PEC/PNEC ratio)
PEC/PNEC = 0.37 µg/L / 142 µg/L = 0.0026
PEC/PNEC < 0.1 which justifies the phrase ”Användning av läkemedlet har bedömts medföra försumbar risk för miljöpåverkan.”
Degradation
Test results from "closed bottle test" (OECD guideline 301D) shows that the biological degradation is 0% in 28 days (Ref. 2). There is no information regarding the metabolites.
Furosemide is potentially persistent.
Bioaccumulation
Partitioning coefficient:
Log Kow ≤ 0 at pH 7, test method used to determine log Kow is a HPLC with C18 analytical column (Ref.2)
Since log Kow < 4, the substance has low potential for bioaccumulation.
References
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ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment. http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm
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Nycomed AB, ”Test Results for the Test Substance Furosemide”, Report No. R 196-05, date 2005-06-14.