Miljöpåverkan
Eliglustat
Miljörisk:
Risk för miljöpåverkan av eliglustat kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att eliglustat är persistent, då data saknas.
Bioackumulering:
Eliglustat 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) = 1.5*10-6*A*(100-R)
PEC = 0.000014 µg/L
Where:
A = 0,0941 kg (total sold amount API in Sweden year 2017, data from IQVIA)
R = 0% removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation)
P = number of inhabitants in Sweden = 9*106
V (L/day) = volume of wastewater per capita and day = 200 (Ref I)
D = factor of dilution of waste water by surface water flow = 10 (Ref I)
According to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of eliglustat is unlikely to represent a risk for the environment, because the predicted environmental concentration (PEC) is below the action limit 0.01 µg/L.
Predicted No Effect Concentration (PNEC)
Ecotoxicological studies: No data available. Since it is not possible to calculate the environmental risk classification (PEC/PNEC ratio), the summary phrase for the environmental risk is: "Risk of environmental impact of eliglustat cannot be excluded, since no ecotoxicity data are available."
Degradation
No data available. Therefore, the summary phrase for degradation to be used is: ”The potential for persistence of eliglustat cannot be excluded, due to lack of data”.
Bioaccumulation
Partitioning coefficient
Log Kow = 2.84 (potentiometric method, pH unknown) (Ref II).
Justification of chosen bioaccumulation phrase:
Since log Kow < 4, eliglustat has low potential for bioaccumulation (Ref II).
Excretion
No data available.
Reference
I. ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment.
II: Cerdelga - Assessment report for an initial marketing authorisation application. 20 November 2014. Retrieved March 28, 2019, from https://www.ema.europa.eu/en/documents/assessment-report/cerdelga-epar-public-assessment-report_en.pdf