Miljöpåverkan
Allopurinol
Miljörisk:
Användning av allopurinol har bedömts medföra medelhög risk för miljöpåverkan.
Nedbrytning:
Allopurinol är potentiellt persistent.
Bioackumulering:
Allopurinol 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) = 1.37*10-6 *A(100-R)
PEC = 0.84 μg/L
Where:
A = 6118.82 kg (total sold amount API in Sweden year 2021, data from IQVIA.)
R = X % removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation) = 0 if no data is available. R=0
P = number of inhabitants in Sweden = 10*106
V (L/day) = volume of wastewater per capita and day = 200 (ECHA default)(Ref.1)
D = factor for dilution of waste water by surface water flow = 10 (ECHA default)(Ref.1)
Predicted No Effect Concentration (PNEC)
Ecotoxicological Studies
Aquatic toxicity:
Daphnia: EC50 48h = 130 mg/L (OECD 202) (Ref. 2
Algea:EC50 72h = 450 µg/L (OECD 201) (Ref. 2)
Fish: LC50 96h > 100 mg/L (OECD 203) (Ref. 2)
PNEC (µg/L) = lowest EC50 / 1000 where 1000 is the assessment factor used for these data. EC50 for green alga (= 450 µg/L) has been used for this calculation since it is the most sensitive of the three tested species.
PNEC = 450 / 1000 = 0.45 µg/L
Environmental risk classification (PEC/PNEC ratio)
PEC/PNEC = 0.84 / 0.45 = 1.86 i.e.
1 < PEC/PNEC ≤ 10 which justifies the phrase "Use of allopurinol has been considered to result in moderate environmental risk".
Degradation
Inherent biodegradation: Test result 2 % degradation in 28 days ( Modified Zahn-Wellens - OECD 302B). (Ref. 2)
The medicine is potentially persistent.
Bioaccumulation
Log Pow = 0.32 (Ref. 3)
This material is not likely to sorb to soil or sediment. Measured soil sorption coefficient,
log Koc is < 1.25. (OECD 121).
References
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[ECHA] European Chemicals Agency. December 2022. Guidance on Information Requirements and Chemical Safety Assessment. Chapter R.16: Environmental exposure assessment (version 3.0)
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British Pharmacopoeia, Safety Data Sheet according to 1907/2006/EC, Article 31, Allopurinol, Revision 23.04.2020.
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Kashim N.A.; et al, 2004. Molecular Pharmaceutics, Vol.1 No.1, 85-96.