Miljöpåverkan (Läs mer om miljöpåverkan)
Ebastin
Miljörisk:
Risk för miljöpåverkan av ebastin kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att ebastin är persistent, då data saknas.
Bioackumulering:
Ebastin har hög 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) = 1.5*10-6*A*(100-R)
PEC = 0,031 μg/L
Where:
A = 203,55 kg (total sold amount API in Sweden year 2016, data from QuintilesIMS)
R = 0% removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation)
P = number of inhabitants in Sweden = 9*106
V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (Ref I)
D = factor of dilution of waste water by surface water flow = 10 (ECHA default) (Ref I)
Environmental risk classification
Risk of environmental impact of Ebastine cannot be excluded, since no ecotoxicity data is available.
Degradation
The potential of persistence cannot be excluded due to lack of data.
Bioaccumulation
log Dow = 4.1 at pH 7 (Reference II)
Since log Dow is > 4 at pH 7 (method unknown) (Reference II), Ebastine has high potential for bioaccumulation.
Excretion (metabolism)
Ebastine is not detected in plasma. The main metabolite detected is Carebastine which is the active metabolite, whilst other minor compounds are also identified. Carebastine is metabolized in turn into various inactive metabolites before excretion. (Reference II)
References
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ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment.
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Almirall's ERA Ebastine 10, 20 mg, 2017.