Miljöpåverkan
Takrolimus (vattenfri)
Miljörisk:
Risk för miljöpåverkan av takrolimus (vattenfri) kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att takrolimus (vattenfri) är persistent, då data saknas.
Bioackumulering:
Takrolimus (vattenfri) har låg potential att bioackumuleras.
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Detaljerad miljöinformation
Environmental Risk Classification
Predicted Environmental Concentration (PEC)
PEC in water 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 = 0,0016 μg/L
A: 11.50 kg (sold amount API in Sweden year 2022 from IQVIA).
R: 0 % removal rate (due to loss by adsorption to sludge particles, by voloatilization, hydrolysis or biodegradation) = 0 since no data is available.
P: 10*106 (number of inhabitants in Sweden)
V: 200 L/day (volume of wastewater per capita and day) (ECHA default) (Ref.1)
D: 10 (factor for dilution of wastewater by surface water flow) (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 tacrolimus is unlikely to represent a risk for the environment, because the predicted environmental concentration (PEC) is below the action limit 0.01 μg/L.
LogP for tacrolimus is reported as 2.7 (Ref.2) and is therefore concluded to have a low potential to bioaccumulate (Ref.3).
References
1. ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessement.
https://echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment, accessed 26-Feb-2024.
2. Pubchem, National Library of Medicine,
Tacrolimus | C44H69NO12 | CID 445643 - PubChem (nih.gov), accessed 26-Feb-2024.
3. https://medlem.lif.se/globalassets/fass-medlemswebb/fass-databasen/environmental-classification-of-pharmaceuticals-att-wwwfassse-211119.pdf, accessed 26-Feb-2024.