Miljöpåverkan
Miljöinformationen för flukloxacillin är framtagen av företaget Meda för Heracillin®
Miljörisk:
Risk för miljöpåverkan av flukloxacillin kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att flukloxacillin är persistent, då data saknas.
Bioackumulering:
Flukloxacillin har låg 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 = 1.76 μg/L
Where:
A = 12 880.16 kg (total amount API of flucloxacillin sodium (monohydrate) and flucloxacillin magnesium octahydrate in Sweden year 2022, 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)
Ecotoxicological studies
No ecotoxicological data available.
Degradation
No degradation data available.
Bioaccumulation
An experimentally derived Log P of 2.58 (unknown method) (Ref. 3) indicates that flucloxacillin has a low potential for bioaccumulation.
Log Pow < 4 which justifies the phrase “Flucloxacillin has low potential for bioaccumulation”.
Excretion (metabolism)
Elimination of flucloxacillin occurs mainly in the kidneys via tubular secretion and glomerular filtration. Within 6 hours, approximately 50-55 % of an orally administered dose is excreted with the urine (Ref. 4).
References:
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Data from IQVIA "Consumption assessment in kg for input to environmental classification" – updated 2023 (data 2022)
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Guidance on information requirements and Chemical Safety Assessment Chapter R.16: Environmental exposure assessment. Version 3.0, February 2016, https://echa.europa.eu/documents/10162/13632/information_requirements_r16_en.pdf/b9f0f406-ff5f-4315-908e-e5f83115d6af
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Sangster (1994), ChemID+, US National Library of Medicin, National Institutes of Health, https://chem.nlm.nih.gov/chemidplus/name/flucloxacilline
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Summary of Product Characteristics, SPC, Flukloxacillin Meda, 2018-08-17,https://www.fass.se/LIF/product?userType=0&nplId=20041007000062&docType=6&scrollPosition=200