Miljöpåverkan
Miljöinformationen för takrolimus (vattenfri) är framtagen av företaget Astellas Pharma för Advagraf, Modigraf, Prograf, Protopy
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.
Läs mer
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) = 1,5*10-6*A(100-R)
PEC = 0,0019 μg/L
A: 12,34 kg (sold amount API in Sweden year 2019 from IMS Health).
R: 0 % removal rate (due to loss by adsorption to sludge particles, by voloatilization, hydrolysis or biodegradation) = 0 since no data is available.
P: 9*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.
http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en
2. Pubchem, National Library of Medicine, https://pubchem.ncbi.nlm.nih.gov/compound/Tacrolimus#section=Chemical-and-Physical-Properties, accessed 26-Mar-2021
3. Guidance to regulation (EC) No1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures. European Chemical Agency, http://guidance.echa.europa.eu/docs/guidance_document/clp_en.pdf