Miljöpåverkan
Aprepitant
Miljörisk:
Användning av aprepitant har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning:
Aprepitant är potentiellt persistent.
Bioackumulering:
Aprepitant 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 = 0.0005 μg/L
Where:
A = 3.3 kg (total sold amount API in Sweden year 2022, IQVIA) (Ref. I)
R = 0 % removal rate (worst case assumption)
P = number of inhabitants in Sweden = 10 *106
V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (Ref. II)
D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Ref. II)
Predicted No Effect Concentration (PNEC)
Ecotoxicological studies
Due to the low solubility, tests were conducted using solvent and solvent control
(approx. 0.55 mg/L in aqueous solution).
Algae, green algae (Pseudokirchneriella subcapitata) OECD 201 (Ref III):
EC50 72 hr (growth; yield) > 0.184 mg/L; no toxicity up to the limit of solubility
NOEC 72 hr (growth; yield) = 0.184 mg/L; no toxicity up to the limit of solubility
Crustacean, water flea (Daphnia magna):
Acute toxicity
EC50 48 h (mortality) > 0.345 mg/L; no toxicity up to limit of solubility (OECD 202)
(Ref. IV)
Chronic toxicity
21 day NOEC (growth) = 0.018 mg/L (OECD 211) (Ref. V)
Fish, Fathead minnow (Pimephales promelas):
Acute toxicity
LC50 96 h (mortality) > 0.462 mg/L (OECD 203) no toxicity up to limit of solubility (Ref.VI)
Chronic toxicity
33 day NOEC (dry weight) = 0.195 mg/L (OECD 210) no toxicity up to the limit of solubility (Rev VII)
PNEC = 1.8 µg/L based on the chronic NOEC for the most sensitive species (D. magna) divided by an assessment factor of 10, per the Guidance.
Environmental risk classification (PEC/PNEC ratio)
PEC/PNEC = 0.0005/1.8 = 0.0003, i.e. PEC/PNEC ≤ 0.1 which justifies the phrase "Use of aprepitant has been considered to result in insignificant environmental risk."
Degradation
Biotic degradation
Biodegradation in sludge:
Test results 50% degradation in 66 days based on CO2 evolution (not rapidly degradable) (OECD 314) (Ref. VIII)
Justification of chosen degradation phrase:
Based on the data presented above, the phrase, “Aprepitant is potentially persistent” is chosen.
Bioaccumulation
Bioconcentration Factor (BCF), bluegill sunfish, (Lepomis macrochirus)(OECD 305)
Steady state BCF (whole fish) 39.2 - 47.9 (Ref. IX)
Justification of chosen bioaccumulation phrase:
Since measured BCF range < 500, the substance has low potential for bioaccumulation.
References
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Data from IQVIA ”Consumption assessment in kg for input to environmental classification - updated 2023 (data 2022)”.
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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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Smithers Viscient AG, 2011. "Aprepitant: Growth Inhibition Test with Pseudokirchneriella subcapitata (syn. Selenastrum capricornutum) under Static Conditions, Following OECD Guideline 201," Study No. 1115.005.430, SV, Horn, Switzerland, 6 June 2011.
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Toxikon Corporation 2003. "Aprepitant: Acute Toxicity to the Water Flea, Daphnia magna, Under Static Conditions," Study No., 03J0004a, TOX, Jupiter, FL, USA 10 November 2003.
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Smithers Viscient AG, 2011. "Aprepitant: Full Life Cycle Toxicity Test with Water Fleas, Daphnia magna, Under Static Renewal Conditions, Following OECD Guideline #211," Study No. 1115.005.230, SV, Horn, Switzerland, 29 June 2011.
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Toxikon Corporation 2003. "Aprepitant: Acute Toxicity to Fathead Minnow, Pimephales promelas, Under Static Conditions," Study No., 03J0004b, TOX, Jupiter, FL, USA 6 November 2003.
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Smithers Viscient AG, 2011. "Aprepitant: Early life-stage toxicity test with fathead minnow (Pimephales promelas) Following OECD Guideline #210," Study No. 1115.005.122, SV, Horn, Switzerland, 27 October 2011.
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Smithers Viscient AG 2011. "Aprepitant: Determination of the Biodegradability in Activated Sludge Based on Procedures of OECD Method 314," Study No., 1115.005.791, SV, Horn, Switzerland 28 January 2011.
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Smithers Viscient AG, 2011. "Aprepitant: Flow-through Bioconcentration Study with Bluegill Sunfish (Lepomis macrochirus)," Study No. 1115.005.135, SV, Horn, Switzerland, 18 November 2011.