Miljöpåverkan
Mesalazin
Miljörisk:
Risk för miljöpåverkan av mesalazin kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att mesalazin är persistent, då data saknas.
Bioackumulering:
Mesalazin har låg potential att bioackumuleras.
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Detaljerad miljöinformation
Mesalazin
Environmental risk: Risk of environmental impact of mesalazin cannot be excluded, since no ecotoxicity data are available.
Degradation: The potential for persistence of mesalazin cannot be excluded, due to lack of data.
Bioaccumulation: Mesalazin has low potential for bioaccumulation.
Detailed background information
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 (μg/L) = 1,37 x 10–6 x 37 011,7914 x 100= 5,07 μg/L. This assumes zero removal.
Where:
A = 37 011,7914 kg total sold amount API of mesalazine in Sweden year 2022, data from IQVIA (Ref. I). Reduction of A may be justified based on metabolism data.
R = X % 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. II)
D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Ref. II)
Predicted No Effect Concentration (PNEC)
There are no Ecotoxicity data available.
Environmental risk classification (PEC/PNEC ratio)
Justification to chosen risk classification phrase:
The risk of environmental impact of mesalazin cannot be excluded, since no ecotoxicity data are available.
Degradation
Justification to chosen dagradation phrase:
The potential for persistence of mesalazin cannot be excluded, due to lack of data
Bioaccumulation
Partitioning coefficient (Ref. III)
Log Kow = 0.98 (est)
Justification of chosen bioaccumulation phrase:
Since log Kow < 4 the substance has low potential for bioaccumulation
References
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Data from IQVIA ”Consumption assessment in kg for input to environmental classification v1 - updated 2023 (data 2022)”.
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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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US EPA; Estimation Program Interface (EPI) Suite. Ver.3.12. Nov 30, 2004. Available from, as of Jan 4, 2007: http://www.epa.gov/oppt/exposure/pubs/episuitedl.htm