Miljöpåverkan
Mitoxantron
Miljörisk:
Risk för miljöpåverkan av mitoxantron kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att mitoxantron är persistent, då data saknas.
Bioackumulering:
Mitoxantron har låg potential att bioackumuleras.
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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) = 1.5*10-6*A(100-R)
PEC = 6,8*10-7 μg/L
Where:
A = 0,0045 kg (total amount API of mitoxantrone hydrochloride in Sweden year 2017, data from IQVIA) (Ref. 1)
R = removal rate = 0% (no data available)
P = number of inhabitants in Sweden = 9*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 mitoxantron 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 estimated log Pow of 2,28 (unknown method) (ref. 3) indicates that mitoxantrone has a low potential to bioaccumulate.
Log Pow < 4 which justifies use of the phrase “Mitoxantron has low potential for bioaccumulation”.
References:
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Data from IQVIA ”Consumption assessment in kg for input to environmental classification - updated 2018 (data 2017)”.
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ECHA, European Chemicals Agency. Guidance on information requirements and chemical safety assessment. Ver 2.1, 2011.
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Meylan WM and Howard PH (1995), ChemID+, US National Library of Medicin