Miljöpåverkan (Läs mer om miljöpåverkan)
Risperidon
Miljörisk:
Användning av risperidon har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning:
Risperidon är potentiellt persistent.
Bioackumulering:
Risperidon har låg potential att bioackumuleras.
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Detaljerad miljöinformation
1. PREDICTED ENVIRONMENTAL CONCENTRATION (PEC):
The Predicted Environmental Concentration is calculated according to the following formula:
PEC (µg/L) |
= |
A x 109 x (100-R) / 365 x P x V x D x 100 |
Where: |
||
A (kg/year) |
= |
total actual API sales in Sweden for the most recent year 15.2176 kg (Sales from 2015 – IMS Health) [8] |
R (%) |
= |
removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation) |
= |
0% (worst-case scenario: no removal) |
|
P |
= |
number of inhabitants in Sweden (9 x 106) |
V (L/day) |
= |
volume of waste water per capita and day |
= |
200 (ECHA default) [7] |
|
D |
= |
factor for dilution of waste water by surface water flow |
= |
10 (ECHA default) [7] |
|
PEC (µg/L) |
= |
0.0023 µg/L |
2. PREDICTED NO EFFECT CONCENTRATION (PNEC)
2.1. Ecotoxicological studies
2.1.1. Algae
Algal growth inhibition test with the green alga (Selenastrum capricornutum) (OECD 201) [1]:
EC50 72 h = 26 mg/L (Inhibition of growth)
2.1.2. Crustacean
Acute
The Acute Toxicity of risperidone to the Water-flea (Daphnia magna) (FDA 4.08) [2]:
EC50 48 h = 6 mg/L (Immobilization)
Chronic
Not available
2.1.3. Fish
Acute
The Acute Toxicity of risperidone to the Bluegill sunfish (Lepomis macrochirus) (FDA 4.00) [3]:
LC50 96 h = 5.8 mg/L (Survival)
Chronic
Not available
2.1.4. Other ecotoxicity data
Toxicity to activated sludge in a respiration inhibition test (OECD 209) [4]:
EC50 3 h > 1000 mg/L (OECD 209)
NOEC = 47 mg/L
2.2. Calculation of Predicted No Effect Concentration (PNEC)
PNEC (µg/l) = lowest EC50/1000, where 1000 is the assessment factor used. EC50 for the Bluegill sunfish 5.8 mg/L has been used for this calculation since it is the most sensitive of the three tested species.
PNEC = 5.8 mg/L/1000 = 5.8 µg/L
2.3. Environmental risk classification (PEC/PNEC ratio)
PEC/PNEC = 0.0023/5.8 = 0.0004 i.e. PEC/PNEC ≤ 0.1
Conclusion for environmental risk:
The calculated PEC/PNEC ratio is ≤ 1. Hence, risk assessment procedures would indicate that Risperidone would have insignificant long-term risk to the environment. This medicine is potentially persistent and has no significant bioaccumulation potential
3. DEGRADATION
3.1. Biotic degradation
3.1.1. Ready biodegradation
Biodegradability in a CO2-evolution test (FDA 3.11) [5]:
Based on the measurements of CO2 produced and DOC analysis, the percentage biodegradation calculated for Risperidone was 5%.
Based on the measurements of CO2 produced and DOC analysis, the percentage biodegradation calculated for the reference substance glucose was > 60%. Consequently, it can be concluded that Risperidone is not readily biodegradable.
Conclusion for degradation:
The medicine is potentially persistent.
4. BIOACCUMULATION
4.1. Partition coefficient octanol/water
Partition coefficient octanol/water (shaking flask method) [6]:
The average apparent partition coefficient (total solute measured, regardless of from) of R064766 in 1-octanol/aqueous solution at 25°C as determined by UV spectrometry is:
-
in 1-octanol/buffer pH 5: log P = 0.22
-
in 1-octanol/buffer pH 7: log P = 1.67
-
in 1-octanol/buffer pH 9: log P = 2.91
Conclusion for bioaccumulation:
As log Pow < 4, risperidone has no significant bioaccumulation potential.
5. REFERENCES
-
Weytjens D.; The effect of risperidone on the growth of the unicellular green alga Selenastrum capricornutum, Janssen Pharmaceutica N.V.; Janssen Study No. AASc/0004; May 14, 1993.
-
Weytjens D.; The acute toxicity of risperidone to the water-flea (Daphnia magna), Janssen Pharmaceutica N.V.; Janssen Study No. ADK6/0017; February 2, 1993.
-
Weytjens D.; The Acute Toxicity of risperidone to the Bluegill sunfish (Lepomis macrochirus), Janssen Pharmaceutica N.V.; Janssen Study No. AFLm/0004; February 2, 1993.
-
Seyfried B.; Toxicity to activated sludge in a respiration inhibition test, RCC Ltd.; RCC Study No. A35087; Janssen Study No. RMD704; April 6, 2006.
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Weytjens D., Biodegradability in a CO2-evolution test, Janssen Pharmaceutica N.V.; Janssen Study No. BDAS0036; January 11, 1993.
-
Van Dingenen J.; R064766: Partition coefficient; Janssen Pharmaceutica N.V., Report PC-CHAR 92-59 (921209) – R064766; December 09, 1992.
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ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment. http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm
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IMS Health - 2015