Miljöpåverkan
Miljöinformationen för trabektedin är framtagen av företaget Immedica Pharma för Yondelis
Miljörisk:
Risk för miljöpåverkan av trabektedin kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att trabektedin är persistent, då data saknas.
Bioackumulering:
Trabektedin har låg potential att bioackumuleras.
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Detaljerad miljöinformation
Predicted Environmental Concentration (PEC)
PEC is calculated according to the following formula:
PEC(μg/L) = (A*109*(100-R))/(365*P*V*D*100)
PEC: 0,0000001 μg/l
Where:
A= 0,0007 kg (estimated total amount API of trabektedin in Sweden year 2023, data from IQVIA 2023 (Ref 1)
R=removal rate =0% (no data available)
P=number of inhabitants in Sweden = 107
V (L/day) =volume of wastewater per capita and day=200 (ECHA default) (Ref.2)
D= factor for dilution of wastewater by surface water flow=10 (ECHA default) (Ref.2)
Predicted No Effect Concentration (PNEC)
No ecotoxicology data are available for trabectedin and no PNEC can be determined. (Ref 3).
Justification of chosen environmental risk phrase:
No exotoxicologi data are available, therefore the phrase chosen for trabectedin is “Risk of environmental impact of trabectedin cannot be excluded, since no ecotoxicity data are available”.
According to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of trabectedin 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 for trabectedin. (Ref 3)
Justification of chosen degradation phrase:
No data are available, therefore the phrase chosen for trabectedin is “The potential for persistence of trabectedin cannot be excluded, due to lack of data”.
Bioaccumulation
The log P of trabectedin determined in accordance to the OECD guideline 107 is 2.5. (Ref 4)
Justification of chosen bioaccumulation phrase:
The log P is <4 which justifies the phrase ”trabectedin has low potential for bioaccumulation”.
References:
1. Data from IQVIA/LIF kg consumption 2023
2. ECHA, European Chemicals Agency. Guidance on information requirements and chemical safety assessment Ver 2.1 2011.
3. Enviromental Risk Assessment Yondelis (trabectedin), internal document
4. Enviromental Risk Assessment Yondelis (trabectedin), addendum, internal document