Miljöpåverkan
Gilteritinib
Miljörisk:
Risk för miljöpåverkan av gilteritinib kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att gilteritinib är persistent, då data saknas.
Bioackumulering:
Gilteritinib 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 x 10-6 x A x (100-R)
PEC = 0.000025 μg/L
A: 0.1894 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 voloatilization, hydrolysis or biodegradation) = 0 since no data is available.
P: number of inhabitants in Sweden = 10 x 106
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 gilteritinibfumarat 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 gilteritinibfumarat is reported to be within the interval 2.79 (Chemaxon) - 3.51 (ALOGPS) (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 assessment.
http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en
2. https://go.drugbank.com/salts/DBSALT002819
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