Miljöpåverkan
Mirabegron
Miljörisk:
Risk för miljöpåverkan av mirabegron kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att mirabegron är persistent, då data saknas.
Bioackumulering:
Mirabegron har låg potential att bioackumuleras.
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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 = 0.089 μg/L
A: 646,6420 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)
Environmental risk classification (PEC/PNEC ratio)
The PEC/PNEC ratio could not be determined because there are not sufficient ecotoxicological test results, hence justifies for the environmental risk standard phrase: "Risk of environmental impact of mirabegron cannot be excluded, since there is not sufficient ecotoxicity data available."/"Risk för miljöpåverkan av mirabegron kan inte uteslutas då ekotoxikologiska data saknas."
Degradation
No data available. This justifies the use of the degradation standard phrase: “The potential for persistence of mirabegron cannot be excluded, due to lack of data.” / “Nedbrytning: Det kan inte uteslutas att mirabegron är persistent, då data saknas.”
Bioaccumulation
LogP for mirabegron is estimated as 1.29 (Ref. 2) via ALOGPS 2.1 online software (Ref. 3). Mirabegron is therefore concluded to have a low potential to bioaccumulate (Ref.4). This justifies the use of the bioaccumulation standard phrase: “Mirabegron has low potential for bioaccumulation” / “Mirabegron har låg potential att bioackumuleras.”. Mirabegron is therefore concluded to have a low potential to bioaccumulate (Ref.3). This justifies the use of the bioaccumulation standard phrase: “Mirabegron has low potential for bioaccumulation” / “Mirabegron har låg potential att bioackumuleras.”
References
1. ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessement.
http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en
2. https://www.chemsrc.com/en/cas/223673-61-8_1170692.html
3. On-line Lipophilicity/Aqueous Solubility Calculation Software (vcclab.org)
4. 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