Miljöpåverkan
Talazoparib
Miljörisk:
Risk för miljöpåverkan av talazoparib kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att talazoparib är persistent, då data saknas.
Bioackumulering:
Talazoparib har låg potential att bioackumuleras.
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Detaljerad miljöinformation
Detailed background information
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 = 0.000000068 μg/L
Bioaccumulation
Where:
|
A = |
0.00049698 kg (total sold amount API in Sweden year 2021)2 |
|
R = |
0% removal rate (worst case scenario) |
|
P = |
number of inhabitants in Sweden = 10×106 |
|
V (L/day) = |
wastewater volume per capita and day = 200 (ECHA default)3 |
|
D = |
factor for waste water dilution by surface water flow = 10 (ECHA default)3 |
Current EU guidelines4 require additional environmental fate and toxicity studies to be conducted for pharmaceuticals if the predicted environmental concentration (PEC) value exceeds the threshold of 0.01μg/L. If the PEC is below 0.01μg/L and no other environmental concerns are apparent, it is assumed that the medicinal product is unlikely to represent a risk for the environment following its prescribed usage in patients.
Talazoparib does not meet the criteria for classification as a Persistent, Bioaccumulative or Toxic (PBT) compound.
The PEC value is less than the 0.01 μg/L action limit. Based on the PEC value, an environmental fate and effects analysis for talazoparib is not required.
Partitioning coefficient (guideline OECD 107)1
|
pH |
Log Dow |
|
5 |
2.04 |
|
7 |
2.08 |
|
9 |
2.05 |
Justification of chosen bioaccumulation phrase
Since log Dow < 4 at pH 7, talazoparib has low potential for bioaccumulation.
References
1. Pfizer, Talzenna environmental risk assessment. March 2018.
2. IQVIA KG Consumption 2021 report.
3. ECHA, European Chemicals Agency. 2016 Guidance on information requirements and chemical safety assessment chapter R16.
4. EMA, European Medicines Agency. 2006 Guideline on the environmental risk assessment of medicinal products for human use. Chapter 4.