Miljöpåverkan
Alfentanil
Miljörisk:
Risk för miljöpåverkan av alfentanil kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att alfentanil är persistent, då data saknas.
Bioackumulering:
Alfentanil har låg potential att bioackumuleras.
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Detaljerad miljöinformation
Appendix 1 - Template for environmental information at
Substance alfentanil
Miljörisk: Risk för miljöpåverkan av alfentanil kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning: Det kan inte uteslutas att alfentanil är persistent, då data saknas.
Bioackumulering: Alfentanil har låg potential att bioackumuleras.
Detailed background information
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 = 4.24*10-5 μg/L
Where:
A = 0.3338 kg (total sold amount API in Sweden year 2021, 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 for dilution of waste water by surface water flow = 10 (ECHA default) (Ref. I)
Predicted No Effect Concentration (PNEC)
No ecotoxicological study results are available, hence the PNEC (μg/L) could not be estimated.
Environmental risk classification (PEC/PNEC ratio)
The PEC/PNEC ratio could not be calculated due to lack of data and therefore justifies the phrase: "Risk of environmental impact of alfentanil cannot be excluded, since no ecotoxicity data are available".
However, according to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of alfentanil 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 are available, hence justifies the phrase: "The potential for persistence of alfentanil cannot be excluded, due to lack of data".
Bioaccumulation Partitioning coefficient:
Log Pow = 2.16 (experimental by unknown method) (Ref II)
Justification for bioaccumulation phrase:
Since log Log P < 4, the substance has low potential for bioaccumulation.
Excretion (metabolism)
Alfentanil is mainly metabolised in the liver. Only 1% of unchanged alfentanil is found in urine. Metabolites are inactive and 70-80% of them are eliminated via the urine.
I. References 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. Hansch C et al. (1995), Drugbank online. https://go.drugbank.com/drugs/DB00802. Retrieved 2022-06-23.
III. SmPC Alfentanil Hameln 0,5 mg/ml injektionsvätska, lösning. MA no. 52797 (2020-08-13).