Miljöpåverkan
Difenhydramin
Miljörisk:
Risk för miljöpåverkan av difenhydramin kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att difenhydramin är persistent, då data saknas.
Bioackumulering:
Difenhydramin 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 = 3.90*10-4 μg/L
Where:
A = 2.85 kg (total amount API of diphenhydramine hydrochloride in Sweden year 2023, data from IQVIA). (Ref. 1)
R = removal rate = 0% (no data available)
P = number of inhabitants in Sweden = 10*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 diphenhydramine 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 experimentally derived Log P of 3.27 (Ref. 3) indicates that diphenhydramine has low potential for bioaccumulation.
Log P < 4 which justifies use of the phrase “Diphenhydramine has low potential for bioaccumulation”.
References:
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Data from IQVIA ”Consumption assessment in kg for input to environmental classification v1 - updated 2024 (data 2023)”.
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ECHA, European Chemicals Agency. Guidance on information requirements and chemical safety assessment. Ver 2.1, 2011.
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Hansch, C et al. (1995), ChemID+, US National Library of Medicin, National Institutes of Health.