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
1. PREDICTED ENVIRONMENTAL CONCENTRATION (PEC):
The Predicted Environmental Concentration is calculated according to the following formula:
|
PEC (µg/L) |
= |
|
|
Where: |
|
|
|
A (kg/year) |
= |
0.8919 kg (total sold amount API in the most recent sales data for Sweden (2018) was distributed by IQVIA in 2019) |
|
R (%) |
= |
removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation) |
|
|
= |
0% (worst-case scenario: no removal) |
|
P |
= |
number of inhabitants in Sweden (9 x 106) |
|
V (L/day) |
= |
volume of waste water per capita and day |
|
|
= |
200 (ECHA default) [1] |
|
D |
= |
factor for dilution of waste water by surface water flow |
|
|
= |
10 (ECHA default) [1] |
|
PEC (µg/L) |
= |
0.000135753 µg/L |
2. PREDICTED NO EFFECT CONCENTRATION (PNEC)
2.1. Ecotoxicological studies
No data available.
2.2. Calculation of Predicted No Effect Concentration (PNEC)
No data available.
2.3. 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.
3. DEGRADATION
3.1. Biotic degradation
3.1.1. Ready biodegradation
No data available.
3.1.2. Simulation study: Aerobic degradation in aquatic sediment systems:
No data available
Conclusion for degradation:
The potential for persistence of Macitentan cannot be excluded, due to lack of data.
4. BIOACCUMULATION
4.1. Partition coefficient octanol/water
Data according open literature [2]:
-
ChemSpider reports:
-
ACD/LogD (pH 7.4): 2.13
-
4.2. Bioconcentration
Data according open literature [2]:
-
ChemSpider reports:
-
ACD/BCF (pH 7.4): 8.44
-
Conclusion for bioaccumulation:
Macitentan has low potential for bioaccumulation.
5. PBT-ASSESMENT
No data available.
6. 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 2019. http://www.chemspider.com/