Miljöpåverkan
Fampridin
Miljörisk:
Risk för miljöpåverkan av fampridin kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att fampridin är persistent, då data saknas.
Bioackumulering:
Fampridin 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 = 0.00062 μg/L
Where:
A = 4.5 kg (Sales data for Sweden in 2022).
R = 0% removal rate. In this assessment 0% is used as a conservative value.
P = 10,000,000 (default value for number of inhabitants in Sweden).
V = 200 L/day (wastewater per capita per day, default value).
D = 10 (dilution, default value).
Predicted No Effect Concentration (PNEC)
There are no toxicity data available.
Environmental risk classification (PEC/PNEC ratio)
Risk of environmental impact of fampridine cannot be excluded, since no ecotoxicity data are available.
Biotic degradation*
Ready degradability:
There is no degradation data available.
Justification of chosen degradation phrase:
The potential for persistence of fampridine cannot be excluded, due to lack of data.
Bioaccumulation
Partitioning coefficient:
e.g. Log Dow = -0.1.48 at pH 7.4 (Ref. I)
Justification of chosen bioaccumulation phrase:
Since the log Dow < 4, the substance has low potential for bioaccumulation.
Excretion (metabolism)
Fampridine is primarily excreted unchanged by the kidneys, with 25% as metabolites (Ref II). The pharmacological activity of the metabolites is not known.
References:
I. Rodríguez-Rangel S, Bravin AD, Ramos-Torres KM, Brugarolas P, Sánchez-Rodríguez JE. 2020. Scientific reports 10:52
II. Blight AR, Henney HR. 2009. Pharmacokinetics of 14C_radioactivity after oral intake of a single dose of 14C-labeled fampridine (4-aminopyridine) in healthy volunteers. Clinical Therapeutics 31(2):328-335