Miljöpåverkan
Vigabatrin
Miljörisk:
Risk för miljöpåverkan av vigabatrin kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att vigabatrin är persistent, då data saknas.
Bioackumulering:
Vigabatrin 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 = 0.022 µg/L
Where:
A =157.2 kg (total sold amount API in Sweden year 2022, 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 (ECHA default) (Ref I)
D = factor of dilution of waste water by surface water flow = 10 (ECHA default) (Ref I)
Predicted No Effect Concentration (PNEC)
No ecotoxicological study results are available.
Environmental Risk Classification (PEC/PNEC ratio)
A PEC/PNEC ratio cannot be calculated due to lack of data, thus justifying the phrase: "Risk of environmental impact of vigabatrin cannot be excluded, since no ecotoxicity data are available".
Degradation
No degradation data is available, hence justifying the degradation phrase:
"The potential for persistence of vigabatrin cannot be excluded, due to lack of data".
Bioaccumulation
Partition coefficient
Log Kow = -2.16 at pH 7
(OECD 107)
(Ref II)
Justification of chosen bioaccumulation phrase:
Since log Kow < 4 at pH 7, vigabatrin has low potential for bioaccumulation.
Excretion (metabolism)
Vigabatrin is not extensively metabolised. No metabolites have been identified in
plasma.
Vigabatrin is eliminated by renal excretion with a half-life of 5-8 hours. About 70 % of one oral single dose was excreted unchanged in the urine for the first 24 hours.
References
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ECHA, European Chemicals Agency, 2008 Guidance on information requirements and chemical safety assessment. https://echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment
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Henczi, M., Nagy, J., Weaver, D.F., 1995. Determination of Octanol-water Partition Coefficients by an HPLC method for Anticonvulsant Structure-activity studies. Journal of Pharmacy and Pharmacology. 47, 345-347.
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SmPC of Sabrilex, retrived from SE MPA website 2021-03-17, find here.