Miljöpåverkan
Imikvimod
Miljörisk:
Risk för miljöpåverkan av imikvimod kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att imikvimod är persistent, då data saknas.
Bioackumulering:
Imikvimod har låg potential att bioackumuleras.
Läs mer
Detaljerad miljöinformation
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 = 5.207*10-4 μg/L
Where:
A = 3.8007 kg (total amount API of imiquimod in Sweden year 2022, data from IQVIA) (Ref. 1).
R = removal rate = 0% (no data available)
P = number of inhabitants in Sweden = 10*106
V (L/day) = volume of waste water per capita and day = 200 (ECHA default) (Ref. 2)
D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Ref. 2)
According to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of imiquimod is unlikely to represent a risk for the environment, because the predicted environmental concentration (PEC) is below the action limit 0.01 μg/L.
Ecotoxicological studies
No ecotoxicological data available.
Degradation
No degradation data available.
Bioaccumulation
An experimentally derived Log Pow of 2.19 (OECD 117) (Ref. 3) indicates that imiquimod has low potential for bioaccumulation.
Log Pow < 4 which justifies use of the phrase “Imiquimod has low potential for bioaccumulation”.
References:
-
Data from IQVIA "Consumption assessment in kg for input to environmental classification" – updated 2021 (data 2022)
-
ECHA, European Chemicals Agency. Guidance on information requirements and chemical safety assessment. Ver 2.1, 2011.
-
Determination of the log Pow of Imiquimod using the HPLC method according to OECD 117 resp. EU A.8 Meda internal document 2011