Miljöpåverkan
Miljöinformationen för hydroxizin är framtagen av företaget UCB Nordic för Atarax
Miljörisk:
Risk för miljöpåverkan av hydroxizin kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att hydroxizin är persistent, då data saknas.
Bioackumulering:
Hydroxizin har låg potential att bioackumuleras.
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Detaljerad miljöinformation
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 = 0.09 μg/L
Where:
A = 606.56 kg (total sold amount API in Sweden year 2020, data from IQVIA).
R = removal rate = 0 % (no data available), assuming zero removal (due to
loss by adsorption to sludge particles, by volatilization, hydrolysis or
biodegradation).
P = number of inhabitants in Sweden = 10×106
V (L/day) = volume of waste water per capita and day = 200 (ECHA default) (Ref I)
D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Ref I)
Predicted No Effect Concentration (PNEC)
Ecotoxicological studies
No ecotoxicity data is available.
Environmental risk classification (PEC/PNEC ratio)
Since no ecotoxicity data is available the PEC/PNEC cannot be calculated, hence justifying the environmental risk classification phrase: "Risk of environmental impact of hydroxyzine cannot be excluded, since no ecotoxicity data are available".
Degradation
No degradation data is available therefore the degradation phrase should be:"The potential for persistence of hydroxyzine cannot be excluded, due to lack of data".
Bioaccumulation
Partitioning coefficient:
An experimentally derived Log Kow of 2.58 at neutral pH (method unknown) (Ref II)
Since Log Kow < 4 at pH 7, hydroxyzine has low potential for bioaccumulation, justifying the phrase: “Hydroxizin has low potential for bioaccumulation”.
Excretion (metabolism)
Hydroxyzine is excreted to < 1 % as parent compound. The most important
metabolite cetirizine is active (also a H1 antagonist with potency assumed
similar to mother compound) and eliminated intact in urine corresponding
to 25 % of the mother compound. (Ref III)
References
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ECHA, European Chemicals Agency. 2016. Guidance on information requirements and chemical safety assessment . Available at: https://echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment
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UCB Pharma Material Safety Data Sheet, Document number: RSDE02F2707,
2007-06-01
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SPC (Summary of Product Characteristics) Atarax, UCB Nordic.