Miljöpåverkan
Guaifenesin
Miljörisk:
Risk för miljöpåverkan av guaifenesin kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att guaifenesin är persistent, då data saknas.
Bioackumulering:
Guaifenesin 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)
PEC = 0.18 μg/L
Where:
A = 1193,954 kg (total sold amount API in Sweden year 2019, data from IQVIA). Reduction of A may be justified based on metabolism data. Note 2020 sales data is not available for this product.
R = 0% removal rate (conservatively, it has been assumed there is no loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation)
P = number of inhabitants in Sweden = 9*106
V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (Reference 1)
D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Reference 1)
Predicted No Effect Concentration (PNEC)
PEC/PNEC could not be calculated due to lack of PNEC data which means that the phrase ‘Risk of environmental impact of Guaifenesine cannot be excluded, since no ecotoxicity data are available’
Ecotoxicological studies
No data available
Microorganisms
No data available
Degradation
No data available
Bioaccumulation
Log P (octanol/water) = 1.39. No significant bioaccumulation potential. (ChemID plus, TOXNET, 2006). Determined by Micellar electrokinetic capillary chromatograph (MECC). Calculated from the retention index following MECC analysis (Joel et al, 1995).
Justification of chosen bioaccumulation phrase:
Since log Pow < 4, the substance has low potential for bioaccumulation.
Excretion (metabolism)
No unchanged drug could be detected in urine following administration of oral guaifenesin (DRUGDEX® Evaluations, 2006).
References
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ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment.
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Joel T. Smith and Dutt V. Vinjamoori (1995) Rapid determination of logarithmic partition coefficients between n-octanol and water using micellar electrokinetic capillary chromatography. Journal of Chromatography B, 669:59-66