Miljöpåverkan (Läs mer om miljöpåverkan)
Hyoscin
Miljörisk:
Risk för miljöpåverkan av hyoscin kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att hyoscin är persistent, då data saknas.
Bioackumulering:
Hyoscin 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)
PEC = 3.89 x 10-4 μg/L
Where:
A = 2.59 kg (total sold amount API in Sweden year 2016, derived from all salt forms, data from Quintiles IMS). Reduction of A may be justified based on metabolism data.
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 hyoscin 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) = 0.98. The substance has low potential for bioaccumulation. (HSDB Scopolamine, TOXNET, 2008). (Reference 2).
Justification of chosen bioaccumulation phrase:
Since log Pow < 4, the substance has low potential for bioaccumulation.
Excretion (metabolism)
2.6% of non-metabolized scopolamine is excreted in urine following oral administration (Renner et al, 2005) (reference 1).
References
1. UD Renner, R Oertel and W Kirch (2005) Pharmacokinetics and Pharmacodynamics in Clinical Use of Scopolamine (Review) Ther. Drug. Monit 27(5):655-664
2. Sangster J; LOGKOW Data Base. Montreal, Quebec, Canada: Sangster Res Lab (1994)