Miljöpåverkan (Läs mer om miljöpåverkan)
oxibuprokain
Miljörisk:
Risk för miljöpåverkan av oxibuprokain kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att oxibuprokain är persistent, då data saknas.
Bioackumulering:
oxibuprokain har låg potential att bioackumuleras.
Läs mer
Detaljerad miljöinformation
Environmental Risk Classification
Predicted Environmental Concentration (PEC)
PEC is based on following data:
PEC (µg/L) = (A*109*(100-R))/(365*P*V*D*100)
PEC (µg/L) = 1.5*10-6*A*(100-R)
A (kg/year) = total sold amount API in Sweden year 2016, data from Quintiles IMS.
R (%) = 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) (Ref.1)
D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Ref.1)
(Note: The factor 109 converts the quantity used from kg to μg).
A =0,5092 kg. The total sold amount of oxybuprocaine hydrochloride in Sweden year 2016, data from Quintiles IMS. (Ref.2)
R =0
PEC = 1.5 * 10-6 *0,5092*(100-0)=0,00007638 µg/L
According to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of oxybuprocaine is unlikely to represent a risk for the environment, because the predicted environmental concentration (PEC) is below the action limit 0.01 µg/L.
Predicted No Effect Concentration (PNEC)
The risk of environmental impact of oxybuprocaine cannot be excluded, since no ecotoxicity data are available.
Degradation
The potential for persistence of oxybuprocaine cannot be excluded, due to lack of data.
Bioaccumulation
The log P-value for oxybuprocaine is 3,1. The log P-value is < 4 which justifies the assigned phrase “Oxybuprocaine has low potential for bioaccumulation”.
References
1. ECHA, European Chemicals Agency.
October 2012 Version: 2.1 Guidance on information requirements and chemical safety assessment.
http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm
2. Data from Quintiles IMS ”Consumption assessment in kg for input to environmental classification - updated 2017”.
3. Oxybuprocaine, National Center for Biotechnology Information. Pubchem Compound Database; http://pubchem.ncbi.nlm.nih.gov/compound/4633#section=Chemical-and-Physical-Properties (accessed July 6, 2017)