Miljöpåverkan
Selexipag
Miljörisk:
Risk för miljöpåverkan av selexipag kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att selexipag är persistent, då data saknas.
Bioackumulering:
Selexipag har låg potential att bioackumuleras.
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Detaljerad miljöinformation
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 |
= |
0.000000274 μg/L |
|
Where: |
|
|
|
A |
= |
0.002 kg (total sold amount API in the most recent sales data for Sweden (2020) was distributed by IQVIA in 2021) |
|
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. 1) |
|
D |
= |
factor for dilution of wastewater by surface water flow = 10 (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 Selexipag is unlikely to represent a risk for the environment, because the predicted environmental concentration (PEC) at the time of registration was below the action limit 0.01 μg/L.
Predicted No Effect Concentration (PNEC)
Ecotoxicological studies
No data available.
Environmental risk classification (PEC/PNEC ratio)
Calculation of Predicted No Effect Concentration (PNEC)
No data available.
Environmental risk classification (PEC/PNEC ratio)
No data available.
Conclusion for environmental risk:
Risk of environmental impact of Selexipag cannot be excluded, since no ecotoxicity data are available.
DEGRADATION
Biotic degradation
Ready biodegradation
No data available.
Inherent biodegradation
No data available.
Conclusion for degradation:
The potential for persistence of Selexipag cannot be excluded, due to lack of data.
BIOACCUMULATION
Partition coefficient octanol/water
Data according to open literature [Ref. 2]:
-
ChemSpider reports:
-
ACD/LogD (pH 7.4): 2.04
-
Bioconcentration
Data according to open literature [Ref. 2]:
-
ChemSpider reports:
-
ACD/BCF (pH 7.4): 6.91
-
Conclusion for bioaccumulation:
Selexipag has low potential for bioaccumulation.
Excretion (metabolism)
No data available.
PBT/vPvB assessment
No data available.
References
-
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 -
ChemSpider 2022. http://www.chemspider.com/