Miljöpåverkan
Betaxolol
Miljörisk:
Risk för miljöpåverkan av betaxolol kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att betaxolol är persistent, då data saknas.
Bioackumulering:
Betaxolol 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) = 1.5*10-6 * A * (100 –R) = 1.5*10-6 * 0.23029 kg * 100
PEC = 0.0000345 μg/L
Where:
A = 0.23029 kg betaxolol hydrochloride (total sold amount API in Sweden year 2018, data from IQVIA).
R = 0 % removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation) = 0 if no data is available.
P = number of inhabitants in Sweden = 9 *106
V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (ECHA 2008)
D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (ECHA 2008)
Predicted No Effect Concentration (PNEC)
Ecotoxicological studies
Algae: no data available
Crustacean (Daphnia magna): no data available
Fish: no data available
Other ecotoxicity data: No data available
PNEC derivation:
No PNEC can be calculated since there is no environmental toxicity data available
Environmental risk classification (PEC/PNEC ratio)
Calculation of a risk ratio is not possible, due to the lack of environmental toxicity data. Therefore, the following phrase is used: "Risk of environmental impact of betaxolol cannot be excluded, since no ecotoxicity data are available."
Degradation
Biotic degradation
Ready degradability: no data available
Justification of chosen degradation phrase:
As no data on biological degradation is available the following phrase is used: ‘The potential for persistence of betaxolol cannot be excluded, due to lack of data.’
Bioaccumulation
Partitioning coefficient:
logKow = 0.155 (method unknown) (Alcon Technical Report 012:38560:0289)
Justification of chosen bioaccumulation phrase:
As log Kow < 4, the following statement is used for Betaxolol: ‘Betaxolol has low potential for bioaccumulation.’
Excretion (metabolism)
Betaxolol is completely absorbed after oral administration. Administration with food does not affect the rate or extent of absorption. The primary route of elimination is hepatic metabolism and urinary excretion. About 15% of a dose is excreted in urine as the unchanged drug but the majority is oxidatively metabolised to inactive and weakly active metabolites, including α-hydroxybetaxolol. There are no active metabolites of clinical importance. (Clarke’s Analysis of Drugs and Poisons, 2017)
PBT/vPvB assessment
Based on screening information, betaxolol cannot be considered a potential PBT substance as the octanol-water partition coefficient remains significantly below the trigger level for a bioaccumulative substance.
References
*ECHA 2008, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment.
http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm
*Alcon Technical Report 012:38560:0289
*Clarke’s Analysis of Drugs and Poisons. Pharmaceutical Press 2017. MedicinesComplete. Royal Pharmaceutical Press.