Miljöpåverkan
Macitentan
Miljörisk:
Risk för miljöpåverkan av macitentan kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att macitentan är persistent, då data saknas.
Bioackumulering:
Macitentan 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 |
= |
0.0001366575 μg/L |
|
Where: |
|
|
|
A |
= |
0.9975 kg (total sold amount API in the most recent sales data for Sweden (2023) was distributed by IQVIA in 2024) |
|
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 Macitentan 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)
Conclusion for environmental risk:
Risk of environmental impact of Macitentan cannot be excluded, since no ecotoxicity data are available.
DEGRADATION
Biotic degradation
Ready biodegradation
No data available.
Conclusion for degradation:
The potential for persistence of Macitentan 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): 2.13
-
Bioconcentration
Data according to open literature [Ref. 2]:
-
ChemSpider reports:
-
ACD/BCF (pH 7.4): 8.44
-
Conclusion for bioaccumulation:
Macitentan 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/