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) = 1.37*10-6*A(100-R)
PEC = 0,0296 μg/L
Where:
A = 216,471 kg (total sold amount API in Sweden year 2023, data from IQVIA)
R = 0 % removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation) = 0 if no data is available.
P = number of inhabitants in Sweden = 10 *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)
Predicted No Effect Concentration (PNEC)
Ecotoxicological studies
No data is available.
Environmental risk classification (PEC/PNEC ratio)
It is not possible to calculate the environmental risk classification (PEC/PNEC ratio) due to lack of data.
Summary phrases for the environmental risk:
Risk of environmental impact of ebastine cannot be excluded, since no ecotoxicity data is available.
Degradation
No degradation data is available.
Summary phrases for degradation:
The potential for persistence of ebastine cannot be excluded, due to lack of data.
Bioaccumulation
Partitioning coefficient:
log Po/w = 4.1 (method and pH unknown)
(Ref. II)
LogP = 6.89 (predicted data, pH unknown (source ALOGPS)),
LogP = 6.96 (predicted data, pH unknown (source Chemaxon))
(Ref. III)
Justification of chosen bioaccumulation phrase:
Since log P > 4, ebastine has high potential for bioaccumulation.
Excretion (metabolism)
Ebastine is rapidly absorbed and converted by first-pass metabolism, mainly via the CYP3A4 system, to the active metabolite carebastine. Carebastine is mainly eliminated in metabolised form.
After an oral dose of ebastine, less than 1 % is excreted in the urine as carebastine. More than 70 % of the dose is excreted in the urine as conjugated metabolites.
Both ebastine and carebastine are highly protein bound, > 97 %.
(Ref. IV)
References