Miljöpåverkan
Solifenacin
Miljörisk:
Risk för miljöpåverkan av solifenacin kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att solifenacin är persistent, då data saknas.
Bioackumulering:
Solifenacin har låg potential att bioackumuleras.
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Detaljerad miljöinformation
Solifenacin succinate
Miljörisk: Risk för miljöpåverkan av solifenacinsuccinate kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning: Det kan inte uteslutas att solifenacinsuccinat är persistent, då data saknas. Bioackumulering: Solifenacinsuccinat har låg potential att bioackumuleras.
Detaljerad miljöinformation
Environmental Risk Classification
Predicted Environmental Concentration (PEC)
PEC in water is calculated according to the following formula:
PEC [µg/L] = (A*109 *(100-R))/(365*P*V*D*100) = 1.37 x 10-6 x A x (100-R)
PEC = 0.0048
A: 34.3542 kg (total sold amount API in Sweden year 2023, data from IQVIA).
R: 0 % removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation) = 0 since no data is available.
P: number of inhabitants in Sweden = 10 x 106
V: 200 L/day (volume of wastewater per capita and day) (ECHA default) (Ref.1)
D: 10 (factor for dilution of wastewater by surface water flow) (ECHA default) (Ref.1)
According to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of solifenacin succinate 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.
Environmental risk classification (PEC/PNEC ratio)
The PEC/PNEC ratio could not be determined because there are not sufficient ecotoxicological test results. This justifies use of the environmental risk standard phrase: Risk of environmental impact of solifenacin succinate cannot be excluded, since there is not sufficient ecotoxicity data available/Risk för miljöpåverkan av solifenacinssuccinat kan inte uteslutas då ekotoxikologiska data saknas.
Bioaccumulation
LogP for solifenacin succinate is reported as 3.67650 (Ref.2) and it is therefore concluded to have a low potential to bioaccumulate (Ref.3). This justifies the use of the bioaccumulation standard phrase: “Solifenacin succinate has low potential for bioaccumulation” / “Solifenacinsuccinat har låg potential att bioackumuleras.”
Degradation
No data available. This justifies the use of the degradation standard phrase: “The potential for persistence of solifenacin succinate cannot be excluded, due to lack of data” / “Nedbrytning: Det kan inte uteslutas att solifenacinsuccinat är persistent, då data saknas.”.
References
1. ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment.
http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en 2. https://www.chemsrc.com/en/cas/242478-38-2_755961.html
3. Guidance to regulation (EC) No1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures. European Chemical Agency, http://guidance.echa.europa.eu/docs/guidance_document/clp_en.pdf