Miljöpåverkan
Miljöinformationen för gabapentin är framtagen av företaget Orion Pharma för Gabapentin Aurobindo, Gabapentin Orion
Miljörisk:
Risk för miljöpåverkan av gabapentin kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att gabapentin är persistent, då data saknas.
Bioackumulering:
Gabapentin 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 (μg/L) = 1.37*10-6*44 796,3068 kg (100-R)
PEC = 6.1 μg/L
Where:
A = 44 796,3068 kg (total sold amount API in Sweden year 2023, data from IQVIA). Metabolism has not been taken into account.
R = 0 % removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation) = 0 since no data is available.
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 for dilution of waste water by surface water flow = 10 (ECHA default) (Ref. I)
Predicted No Effect Concentration (PNEC)
Ecotoxicological studies*
Ecotoxicological studies not available.
Environmental risk classification (PEC/PNEC ratio)
PNEC not available.
Degradation
Biotic degradation
Ready degradability:
No studies available.
Inherent degradability:
No studies available.
Simulation studies:
No studies available.
Abiotic degradation
Hydrolysis:
No studies available.
Photolysis:
No studies available.
Justification of chosen degradation phrase:
The potential for persistence of gabapentin cannot be excluded, due to lack of data.
Bioaccumulation
Bioconcentration factor (BCF):
No data available
Partitioning coefficient:
Log P = -1.25 at pH 7.4 (Ref. II)
Justification of chosen bioaccumulation phrase:
Since log Dow < 4 at pH 7, the substance has low potential for bioaccumulation.
Excretion (metabolism)
Gabapentin is excreted 100% as parent compound. (Ref. III))
PBT/vPvB assessment
There is not sufficient information for classification of gabapentin as PBT/vPvB substance.
References
I. ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment. http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm
II. Bockbrader, H.N., Wesche, D., Miller, R. et al. (2010) A Comparison of the Pharmacokinetics and Pharmacodynamics of Pregabalin and Gabapentin. Clin Pharmacokinet 49, 661–669.
III. McLean, M.J., (1994) Clinical pharmacokinetics of gabapentin. Neurology 44, S17–S22.