Miljöpåverkan
Kariprazin
Miljörisk:
Risk för miljöpåverkan av kariprazin kan inte uteslutas då det inte finns tillräckliga ekotoxikologiska data.
Nedbrytning:
Det kan inte uteslutas att kariprazin är persistent, då data saknas.
Bioackumulering:
Kariprazin har låg potential att bioackumuleras.
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Detaljerad miljöinformation
Environmental Risk Classification
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 = 9.5 x 10-5 μg/L
Where:
A = 0.6948 kg (total sold amount API in Sweden year 2021, data from IQVIA). Reduction of A may be justified based on metabolism data.
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. I)
D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Ref. I)
Degradation
The potential for persistence of Kariprazin cannot be excluded, due to lack of data.
Bioaccumulation
Cariprazine is a small molecule with Mw <500 g/mol. At pH 7 it is freely soluble in methanol and poorly soluble in water. Although logD exceeds 3, the potential for bioaccumulation for this substance is considered unlikely.
In regard to the data stated in the table below (obtained from EPAR, Reagila International non-proprietary name: cariprazine Procedure No. EMEA/H/C/002770/0000) cariprazine is not expected to pose a risk to the environment (Ref II)
Table 1. Summary of main study results
|
Substance (INN):cariprazine |
|||
|
PBT screening |
Result |
Conclusion |
|
|
Bioaccumulation potential- log Kow |
OECD107 |
3.22 |
Potential PBT N |
|
PBT-assessment |
|||
|
Parameter |
Result relevant for conclusion |
Conclusion |
|
|
Bioaccumulation |
log Kow |
3.22 |
Not B |
|
BCF |
29-525 L/kg |
Not B |
|
|
Persistence |
DT50 or ready biodegradability |
Not P |
|
|
PBT-statement: |
The compound is not considered as PBT nor vPvB |
||
|
Phase I |
|||
|
Calculation |
Value |
Unit |
Conclusion |
|
PEC surfacewater , refined |
0.00166 - 0.00697 |
mikrog/L |
> 0.01 threshold N |
|
Other concerns (e.g. chemical class) |
N |
||
Ref (II).
References
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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
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EPAR: Reagila International non-proprietary name: cariprazine Procedure No. EMEA/H/C/002770/0000