Miljöpåverkan
Ketamin
Miljörisk:
Risk för miljöpåverkan av ketamin kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att ketamin är persistent, då data saknas.
Bioackumulering:
Ketamin har låg potential att bioackumuleras.
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Detaljerad miljöinformation
Predicted Environmental Concentration (PEC)
Detaljerad miljöinformation PEC baseras på följande data:
PEC (μg/L) = (A*109*(100-R))/(365*P*V*D*100) = 1,37*10-6*A(100-R)
PEC = 0,001109 μg/L
Where:
A = 8,0937 kg (total sold amount API in Sweden year 2023, data from IQVIA). Reduction of A may be justified based on metabolism data.
R = X % removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation) = 0 if 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. 1)
According to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of ketamine is unlikely to represent a risk for the environment, because the predicted environmental concentration (PEC) is below the action limit 0.01 μg/L.
Degradation
No degradation data available.
Bioaccumulation
For ketamine with a pKa of approximately 7.5 (strongest basic) the predicted logDow at a pH of 7.4 is 2.07 which is below the trigger value of ≤4 and indicate that ketamin has low potential for bioaccumulation. (Ref 2).
References
1. ECHA, European Chemicals Agency. Guidance on information requirements and chemical safety assessment. Ver 2.1, 2011.
2. Drug Bank online. ChemAxon, accessed 04/06/2024.