Miljöpåverkan
Fenylefrin
Miljörisk:
Risk för miljöpåverkan av fenylefrin kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att fenylefrin är persistent, då data saknas.
Bioackumulering:
Fenylefrin 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) = 1.37*10-6*A(100-R)
PEC = 0.001 μg/L
Where:
A = 7.5890 kg Phenylephrine hydrochloride (total sold amount API in Sweden year 2021, data from IQVIA). (Ref I)
R = 0 % removal rate
P = number of inhabitants in Sweden = 10 *106
V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (Ref. II)
D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Ref. II)
According to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of phenylephrine is unlikely to represent a risk for the environment, because the predicted environmental concentration (PEC) at the time of registration was below the action limit 0.01 μg/L.
Environmental risk classification (PEC/PNEC ratio)
Risk of environmental impact of phenylephrine cannot be excluded, since no ecotoxicity data are available.
Degradation
The potential for persistence of phenylephrine cannot be excluded, due to lack of data.
Bioaccumulation
Partitioning coefficient:
e.g. Log Dow = -2.04 at pH 7.4. (Ref III)
Justification of chosen bioaccumulation phrase:
Since log Dow < 4 at pH 7, the substance has low potential for bioaccumulation.
References
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Data from IQVIA ”Consumption assessment in kg for input to environmental classification, updated 2022 (data 2021)”.
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ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment. http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm
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Hazardous Substances Data Bank (HSDB). Hazardous Substance Data Bank number: 5818http://www.chemspider.com/Chemical-Structure.5818.html