Miljöpåverkan
Levetiracetam
Miljörisk:
Risk för miljöpåverkan av levetiracetam kan inte uteslutas då det inte finns tillräckliga ekotoxikologiska data.
Nedbrytning:
Levetiracetam är potentiellt persistent.
Bioackumulering:
Levetiracetam 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 = 1.28 µg/l
Where:
A = 8559.45 kg (total sold amount API in Sweden year 2020, 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 = 10*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)
Predicted No Effect Concentration (PNEC)
Ecotoxicological studies
Crustacean (Daphnia magna):
EC50 48 h (immobilization): > 100 000 μg/l
(Protocol: OECD 202)
(Ref II)
Environmental risk classification (PEC/PNEC ratio)
The PEC/PNEC ratio could not be determined because there are not sufficient ecotoxicological test results, hence justifies for the environmental risk standard phrase ”Risk of environmental impact of levetiracetam cannot be excluded, since there is not sufficient ecotoxicity data available” .
Degradation
Biotic degradation
Ready degradability: Results show not more than 4 % degradation in 28 days.
(Protocol: OECD 301) (Ref II and III)
Levetiracetam does not pass the criteria for ready biodegradability and since there is no information available on grade of mineralisation the phrase: ”Levetiracetam is potentially persistent” should be used.
Bioaccumulation
Partitioning coefficient: Log Pow = -0.64 at pH 7.4 (method unknown) (Ref II)
Since log Pow < 4 at neutral pH, the substance has low potential for bioaccumulation
Excretion (Metabolism)
Approximately 34 % of a levetiracetam dose is metabolised and 66 % is excreted in urine unmetabolised (Ref II). The metabolite is pharmacologically inactive and also excreted in urine (Ref IV).
References:
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ECHA, European Chemicals Agency. Guidance on information requirements and chemical safety assessment, version 3.0 Feb 2016.
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Internal document: UCB MSDS RSDE02F2710 (26 June 2007)
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Environmental assessment for Keppra oral solution (NDA 21‑5050). http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021505_s000_Keppra_EAFONSI.pdf
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Patsalos PN. Pharmacokinetic profile of levetiracetam: toward ideal characteristics. Pharmacol Ther. 2000 Feb;85(2):77‑85. http://www.ncbi.nlm.nih.gov/pubmed/10722121