Miljöpåverkan (Läs mer om miljöpåverkan)
Apraklonidin
Miljörisk:
Risk för miljöpåverkan av apraklonidin kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att apraklonidin är persistent, då data saknas.
Bioackumulering:
Apraklonidin har låg potential att bioackumuleras.
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Detaljerad miljöinformation
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) = 1.5*10-6 * 0.29 kg * 100
PEC = 0.0000435 μg/L
Where:
A = 0.29 kg (total sold amount API in Sweden year 2015, data from IMS Health).
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 = 9 *106
V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (ECHA 2008)
D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (ECHA 2008)
Predicted No Effect Concentration (PNEC)
Ecotoxicological studies
Algae: no data available
Crustacean (Daphnia magna): no data available
Fish: no data available
Other ecotoxicity data: No data available
PNEC derivation:
No PNEC can be calculated since there is no environmental toxicity data available
Environmental risk classification (PEC/PNEC ratio)
Calculation of a risk ratio is not possible, due to the lack of environmental toxicity data. Therefore, the following phrase is used: Risk of environmental impact of apraklonidin cannot be excluded, since no ecotoxicity data are available.
Degradation
Biotic degradation
Ready degradability: no data available
Justification of chosen degradation phrase:
As no data on biological degradation is available the following phrase is used: ‘The potential for persistence of apraklonidin cannot be excluded, due to lack of data.’
Bioaccumulation
Partitioning coefficient:
Log Kow = -1.075 (method unknown) (Alcon Technical Report No. 028:33700:0487)
Justification of chosen bioaccumulation phrase:
As log Kow < 4, the following statement is used for apraklonidin: ‘Apraklonidin has low potential for bioaccumulation.’
Excretion (metabolism)
The metabolism and excretion of apraclonidine following topical administration is unknown.
PBT/vPvB assessment
Based on screening information, apraklonidin cannot be considered a potential PBT substance as the octanol-water partition coefficient remains significantly below the trigger level for a bioaccumulative substance.
References
Alcon Technical Report No. 028:33700:0487