Miljöpåverkan
Ursodeoxicholsyra
Miljörisk:
Risk för miljöpåverkan av ursodeoxicholsyra kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att ursodeoxicholsyra är persistent, då data saknas.
Bioackumulering:
Ursodeoxicholsyra har låg potential att bioackumuleras.
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Detaljerad miljöinformation
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) = 0.26 μg/L
Where:
A (kg/year) = 1909.53 (total sold amount API in Sweden year 2022, 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 = 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)
Ecotoxicological studies
No ecotoxicological data available.
Degradation
No degradation data available.
Bioaccumulation
An experimentally derived log P of 3,0 (unknown method) (Ref. 3) indicates that ursodeoxycholic acid has low potential for bioaccumulation.
Log P < 4 which justifies use of the phrase “Ursodeoxycholic acid 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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Data from IQVIA ”Consumption assessment in kg for input to environmental classification v1 - updated 2023 (data 2022)”.
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Ursodeoxycholic acid, National Center for Biotechnology Information. Pubchem Compound Database; https://pubchem.ncbi.nlm.nih.gov/compound/Ursodeoxycholic-acid#section=Solubility accessed Sep 23, 2020).