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Aprepitant Sandoz

Miljöinformation
Sandoz AS

Kapsel, hård 80 mg
(Tillhandahålls för närvarande ej)

Aktiv substans:
ATC-kod: A04AD12
Läkemedel från Sandoz AS omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöpåverkan (Läs mer om miljöpåverkan)

Miljöinformationen för aprepitant är framtagen av företaget MSD för EMEND

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) = 1.5*10-6*A(100-R)


PEC = 0.0009 μg/L


Where:

A = 5.9 kg (total sold amount API in Sweden year 2016, QuintilesIMS).

R = 0 % removal rate (worst case assumption)

P = number of inhabitants in Sweden = 9 *106

V (L/day) = volume of wastewater 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

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 II):

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. III)


Chronic toxicity

21 day NOEC (growth) = 0.018 mg/L (OECD 211) (Ref. IV)


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.V)


Chronic toxicity

33 day NOEC (dry weight) = 0.195 mg/L (OECD 210) no toxicity up to the limit of solubility (Rev VI)

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 = .0009/1.8 = 0.0005, i.e. PEC/PNEC ≤ .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 (i.e., no biodegradation) (OECD 314). (Ref. VII)


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.VIII)


Justification of chosen bioaccumulation phrase:

Since measure BCF range < 500, the substance has low potential for bioaccumulation.


References

I. 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

II. 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.

III. 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.

IV. 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.

V. Toxikon Corporation 2003. "Aprepitant: Acute Toxicity to Fathead Minnow, Pimephales promelas, Under Static Conditions," Study No., 03J0004b, TOX, Jupiter, FL, USA 6 November 2003.

VI. 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.

VII. 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.

VIII. 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.