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Arcoxia®

MiljöinformationReceptstatusFörmånsstatus
MSD

Filmdragerad tablett 30 mg
(Blågröna, äppelformade, bikonvexa tabletter märkta "101" på ena sidan och "ACX 30" på den andra sidan.)

Antiinflammatoriska och antireumatiska medel, icke-steroida medel, coxiber

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ATC-kod: M01AH05
Läkemedel från MSD omfattas av Läkemedelsförsäkringen.
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Miljöpåverkan (Läs mer om miljöpåverkan)

Etoricoxib

Miljörisk: Användning av etoricoxib har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning: Etoricoxib är potentiellt persistent.
Bioackumulering: Etoricoxib 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 = 0.07 μg/L


Where:

A = 492 kg (total sold amount API in Sweden year 2015, data from IMS Health).

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

Green Algae (Selenastrum capricornutum) (OECD 201) (Ref. II):

EC50 72 h (yield and growth rate)> 10 mg/L

NOEC ≥ 10 mg/L

No effects seen at highest concentration tested


Crustacean, water flea (Daphnia magna):

Acute toxicity

EC50 48 h (mortality) > 30 mg/L (OECD 202) (Ref. III)

No effects seen at highest concentration tested


Chronic toxicity

21-day NOEC (reproduction) = 0.75 mg/L (OECD 211) (Ref. IV)


Fish, fathead minnow (Pimephales promelas):

Acute toxicity

LC50 96 h (mortality) > 30 mg/L (OECD 203) (Ref.V)

No effects seen at highest concentration tested


Chronic toxicity

32-day NOEC ≥ 7.9 mg/L (OECD 210) (Ref. VI)

No effects seen at highest concentration tested


PNEC = 75 μg/L (0.75 mg/L / 10 based on the most sensitive NOEC for the daphnid and an assessment factor (AF) of 10)


Environmental risk classification (PEC/PNEC ratio)

PEC/PNEC = 0.07/75 = 0.001, i.e. PEC/PNEC ≤ .1 which justifies the phrase "Use of etoricoxib has been considered to result in insignificant environmental risk.”


Degradation

Biotic degradation

Ready degradability:

Negligible (<0.2%) biodegradation in 28 days (OECD 314). (Ref. VII)


Sediment Transformation:

Negligible degradation (OECD 308) (Ref. VIII)


The test item moved slowly but steadily from the water phase into the sediment. In both water/sediment systems, radioactivity was still detectable in the water phase at test end after 100 days of incubation. The half-life of [14C] Etoricoxib was calculated to be 7.7 and 10.0 days in the water phases of the Espel and Untereggen water/sediment systems, respectively. In the sediment extracts of the Espel and Untereggen water/sediment systems, no half-life was calculated due to a steadily increase of the test item concentration until test termination at day 100. No metabolites were detected in both water/sediment systems. No substantial mineralization was observed in both water/sediment systems. The system with sediment Espel showed an average formation of CO2 up to 0.4% until test end at day 100. The system Untereggen showed an average formation of CO2 up to 0.6% at test termination.


Justification of chosen degradation phrase:

No study has shown an appreciable degradation of etoricoxib. The phrase “Etoricoxib is potentially persistent” is thus chosen.


Bioaccumulation

Partitioning coefficient:

Log Kow = 2.3 at pH 7 (OECD 107). (Ref.IX)


Justification of chosen bioaccumulation phrase:

Since log Kow < 4, the substance has low potential for bioaccumulation


References

  1. 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

  2. Springborn Smithers Laboratories 2010. "Etoricoxib: Growth Inhibition Test with Pseudokirchneriella subcapitata (syn. Selenastrum capricornutum) Under Static Conditions, Following OECD Guideline 201," Study No., 1115.003.430, SSL, Horn, Switzerland, 07 September 2010.

  3. Toxikon Corporation 2003. "Etoricoxib: Acute Toxicity to the Water Flea, Daphnia magna, Under Static Conditions," Study No., 03J0012a, TOX, Jupiter, FL, USA 02 October 2003.

  4. Smithers Viscient 2010. "Etoricoxib: Full Life Cycle Toxicity Test with Water Fleas, Daphnia magna, Under Static Renewal Conditions, Following OECD Guideline #211," 1115.003.230, SV, Horn, Switzerland 10 December 2010.

  5. Toxikon Corporation 2003. "Etoricoxib: Acute Toxicity to Fathead Minnow, Pimephales promelas, Under Static Test Conditions," Study No., 03J0012b, TOX, Jupiter, FL, USA 02 September 2003.

  6. Smithers Viscient 2011. "Early-Life Stage Toxicity Test with Fathead Minnow (Pimephales promelas) Following OECD Guideline #210," Study No., 1115.003.122, SV, Horn, Switzerland 31 January 2011.

  7. Springborn Smithers Laboratories 2010. "Etoricoxib: Determination of the Biodegradability in Activated Sludge Based on Procedures of OECD Method 314," Study No., 1115.003.791, SSL, Horn, Switzerland 26 August 2010.

  8. Smithers Viscient 2010. "Etoricoxib: Aerobic Transformation in Aquatic Sediment Systems," Study No., 1115.003.750, SV, Horn, Switzerland 21 December 2010.

  9. Springborn Smithers Laboratories 2010. "Etoricoxib: Determining the Partition Coefficient (n-Octanol/Water) by the Shake Flask Method Following OECD Guideline 107," Study No., 1115.003.705, SSL, Horn, Switzerland 15 June 2010.