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 P_ow = 0.11 (23°C, experimentally determined, method unknown)

(Novartis internal data, Analytical Information about Lioresal) 

Justification of chosen bioaccumulation phrase:

As log P_ow < 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

• 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

  
  

• Ciba-Geigy, Test No: 811787, 24.3.1982 (full reference not available)

• Ciba-Geigy, Test No. 811786; 22.2.1982 (full reference not available)

• Novartis internal data, Analytical Information about Lioresal. 10. May 1994

• Novartis Core data sheet LIORESAL^® (baclofen), Version 3.2. 09. December 2019.