Miljöpåverkan
Bensydamin
Miljörisk:
Risk för miljöpåverkan av benzydamin kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att benzydamin är persistent, då data saknas.
Bioackumulering:
Benzydamin har hög potential att bioackumuleras.
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Detaljerad miljöinformation
Detailed background information
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 = 0,009 μg/L
Where:
A = 66,15 kg (total amount API in Sweden year 2023, data from IQVIA).
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. 1)
D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Ref. 1)
According to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of Benzydamine 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 estimated Log P of 4,21 (unknown method) (Ref. 2) indicates that Benzydamine has high potential for bioaccumulation.
Log P > 4 which justifies use of the phrase “Benzydamine has high potential for bioaccumulation”.
Excretion (metabolism)
Excretion occurs mainly in urine, primarily as inactive metabolites or conjugates. (Ref. 3)
References:
1. ECHA, European Chemicals Agency. Guidance on information requirements and chemical safety assessment. Ver 2.1, 2011. http://echa.europa.eu/documents/10162/13643/information_requirements_r2_en.pdf
2. Meylan WM & Howard PH (1995), ChemID+, US National Library of Medicin, National Institutes of Health, http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp
3. SPC (Summary of Product Characteristics) Andolex, 2022-04-05, FASS.se
4. Data from IQVIA “Consumption assessment in kg for input to environmental classification – updated 2024 (data 2023)