Miljöpåverkan
Bendamustin
Miljörisk:
Risk för miljöpåverkan av bendamustin kan inte uteslutas då det inte finns tillräckliga ekotoxikologiska data.
Nedbrytning:
Det kan inte uteslutas att bendamustin är persistent, då data saknas.
Bioackumulering:
Bendamustin har hög potential att bioackumuleras.
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Detaljerad miljöinformation
Miljörisk
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 * 2.05 * (100-0)
Where:
A = 2.05 kg (total sold amount API in Sweden year 2022, data from IQVIA).
R = % 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 = 10*106
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)
PEC = 2.8 * 10-4 μg/L
According to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of bendamustine is unlikely to represent a risk for the environment, because the predicted environmental concentration (PEC) is below the action limit 0.01 μg/L.
Predicted No Effect Concentration (PNEC)
No data available so cannot be calculated.
Environmental risk classification (PEC/PNEC ratio)
Cannot be calculated due to unavailable PNEC.
Nedbrytning
No data is available.
Bioackumulering
LogP = 4.23 (Ref 2)
If Log P > 4 at pH 7 the substance has high 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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PubChem, 2020-06-11 https://pubchem.ncbi.nlm.nih.gov/compound/65628#section=Octanol-Water-Partition-Coefficient
(Estimated, US EPA; Estimation Program Interface (EPI) Suite. Ver. 4.0. Jan, 2009)