Miljöpåverkan
Klavulansyra
Miljörisk:
Risk för miljöpåverkan av klavulansyra kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att klavulansyra är persistent, då data saknas.
Bioackumulering:
Klavulansyra 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 = 0.0276 μg/L
Where:
A = 201.53 kg (total amount API of potassium clavulanate in Sweden year 2020, 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 estimated Log Pow of -2,04 (unknown method) (Ref. 3) indicates that clavulanic acid has low potential for bioaccumulation.
Log Pow < 4 which justifies use of the phrase “Clavulanic acid has low potential for bioaccumulation”.
Excretion (metabolism)
Clavulanic acid is eliminated through both renal and non-renal mechanisms. Approximately 40-65% of the substance is excreted as the unchanged form in urine during the first 6 hours following administration of a single dose. Different studies have shown that urine excretion is 27-60% during a 24-hour period. A majority is excreted during the first two hours after administration. (Ref. 4)
References:
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Data from IQVIA ”Consumption assessment in kg for input to environmental classification v1 - updated 2021 (data 2020)”.
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ECHA, European Chemicals Agency. Guidance on information requirements and chemical safety assessment.
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Meylan WM & Howard PH (1995), ChemID+, US National Library of Medicin, National Institutes of Health.
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SPC (Summary of Product Characteristics) Spektramox, 2018-09-18, FASS.se.