Miljöpåverkan
Glasdegib
Miljörisk:
Risk för miljöpåverkan av glasdegib kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att glasdegib är persistent, då data saknas.
Bioackumulering:
Glasdegib 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 = 0 μg/L
Where:
|
A = |
0 kg (total sold amount API in Sweden year 2022)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 0.01 μg/L. If the PEC is below 0.01 μg/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.
Glasdegib 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 glasdegib is not required.
Bioaccumulation
Partitioning coefficient (guideline OECD 107) 1
Log Dow = 2.59 at pH 5
Log Dow = 3.64 at pH 7
Log Dow = 3.98 at pH 9
Justification of chosen bioaccumulation phrase
Since log Dow < 4 at pH 7, the substance has low potential for bioaccumulation.
References
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Pfizer (EAG Laboratories, EAG, Inc.), Study report 260K-104: Determination of the n-octanol/water partition coefficient of glasdegib by the shake flask method. November 2018.
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Internal data, product not marketed in Sweden.
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ECHA, European Chemicals Agency. 2016 Guidance on information requirements and chemical safety assessment chapter R16.
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EMA, European Medicines Agency. 2006 Guideline on the environmental risk assessment of medicinal products for human use. Chapter 4.