Miljöpåverkan
Baklofen
Miljörisk:
Risk för miljöpåverkan av baklofen kan inte uteslutas då det inte finns tillräckliga ekotoxikologiska data.
Nedbrytning:
Baklofen är potentiellt persistent.
Bioackumulering:
Baklofen 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 * 100.7 kg * 100
PEC = 0.0151 μg/L
Where:
A = 100.7 kg (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:
Acute toxicity (Brachydanio rerio, zebra fish)
LC50 96 h (mortality) > 580.0 mg/L (OECD203) (Ciba-Geigy, Test No: 811787)
Other ecotoxicity data: No data available
PNEC derivation:
No PNEC can be calculated since there is not sufficient 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 baclofen cannot be excluded, since there is not sufficient ecotoxicity data available."
Degradation
Biotic degradation
Ready degradability:
11.1 % degradation in 28 days, not readily biodegradable (OECD301D). (Ciba-Geigy, Test No. 81 17 86)
Justification of chosen degradation phrase:
Baclofen does not pass the criteria for ready biodegradation. Therefore, it can be classified as ‘Baclofen is potentially persistent.’
Bioaccumulation
Partitioning coefficient:
Log Pow = 0.11 (23°C, experimentally determined, method unknown)
(Novartis internal data, Analytical Information about Lioresal)
Justification of chosen bioaccumulation phrase:
As log Pow < 4, the following statement is used for baclofen: ‘Baclofen has low potential for bioaccumulation.’
Excretion (metabolism)
Baclofen is excreted largely in unchanged form. Within 72 hours approximately 75% of the dose is excreted via the kidneys, about 5% of this quantity being in the form of metabolites. The remainder of the dose, including 5% as metabolites, is excreted in the feces. (Novartis Core data sheet LIORESAL®).
PBT/vPvB assessment
Based on screening information, baclofen cannot be considered a potential PBT substance as the octanol-water partition coefficient remains significantly below the trigger level for a bioaccumulative substance.
References
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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
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Ciba-Geigy, Test No: 811787, 24.3.1982 (full reference not available)
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Ciba-Geigy, Test No. 811786; 22.2.1982 (full reference not available)
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Novartis internal data, Analytical Information about Lioresal. 10. May 1994
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Novartis Core data sheet LIORESAL® (baclofen), Version 3.2. 09. December 2019.