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Montelukast Teva

MiljöinformationReceptstatusFörmånsstatus
Teva

Granulat 4 mg
(vitt till benvitt)

Leukotrienreceptorantagonist

Aktiv substans:
ATC-kod: R03DC03
Läkemedel från Teva omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöpåverkan (Läs mer om miljöpåverkan)

Miljöinformationen för montelukast är framtagen av företaget MSD för Singulair-AR®, Singulair®

Miljörisk: Användning av montelukast har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning: Montelukast är potentiellt persistent.
Bioackumulering: Montelukast har hög potential att bioackumuleras.


Läs mer

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 = 0.018 μg/L


Where:

A = 118 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*

Due to the low solubility, tests were conducted using solvent and solvent control.


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

EC50 72 h (yield & growth rate) > 100000 μg/L

NOEC = 100000 μg/L

Non-toxic up to limit of solubility (<0.1 mg/L)


Crustacean, water flea (Daphnia magna):

Acute toxicity

EC50 48 h (mortality) > 70 μg/L (OECD 202) (Ref. III)

Non-toxic up to limit of solubility (<0.1 mg/L)


Crustacean, mysid (Americamysis bahia):

Chronic toxicity

NOEC 14 days (fecundity) = 19 μg/L (US EPA 850.1035) (Ref. IV)


Fish, fathead minnow (Pimephales promelas):

Acute toxicity

LC50 96 h (mortality) > 80 μg/L (OECD 203) (Ref.V)

Non-toxic up to limit of solubility (<0.1 mg/L)


Chronic toxicity

NOEC 32 days (percent live normal fry, total length and dry weight) = 73 μg/L (OECD 210) (Ref. VI)


Fish, rainbow trout (Oncorhynchus mykiss):

Acute toxicity

LC50 96 h (mortality) = 4500 μg/L (US FDA 4.11) (Ref. VII)

Non-toxic up to limit of solubility (<0.1 mg/L)


Fish, sheepshead minnow (Cyprinodon variegatus):

Chronic toxicity

NOEC 7 days (mortality, growth) > 80 μg/L (US EPA 850.1075) (Ref.VIII)

PNEC = 1.9 μg/L (19 μg/L / 10 based on the most sensitive chronic NOEC for the crustacean (mysid) with the fecundity endpoint and an assessment factor (AF) of 10)


Environmental risk classification (PEC/PNEC ratio)

PEC/PNEC = .018/1.9 = 0.009, i.e. PEC/PNEC ≤ .1 which justifies the phrase "Use of montelukast has been considered to result in insignificant environmental risk.


Degradation*

Biotic degradation

Ready degradability:

Test results -8 % degradation in 28 days based on CO2 evolution (i.e., no biodegradation)

(OECD 301B). (Ref. IX)


Biodegradation Simulation Screening

Test results 84% and >95% degradation in 11 days in wastewater effluent, and river sediment samples, respectively measured as loss of parent. Degradation products were identified via HPLC as more polar than the parent. No definitive identification was made. (US FDA 3.11) (Ref. X)


Abiotic degradation

Hydrolysis:

Test results 86 % degradation in 21 hours (US FDA 3.09). (Ref. XI)


Photolysis:

Test results >85% degradation in 15 min; compound not detected by 75 min (US FDA 3.10). (Ref. XII)


Justification of chosen degradation phrase:

Montelukast does not pass the ready biodegradation test but is degradable via hydrolysis, photolysis and in acclimated biological systems and river sediments. However, given that no toxicity data is available for metabolites, the phrase “Montelukast is potentially persistent” is thus chosen.


Bioaccumulation

Partitioning coefficient:

Log Dow > 4.3 at pH 7 (OECD 107). (Ref.XIII)

Justification of chosen bioaccumulation phrase:

Since log Dow > 4 at pH 7, the substance has high 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. Toxikon Corporation, 2003. "SINGULAIR: Acute Toxicity to the Freshwater Green Alga, Selenastrum capricornutum, Under Static Test Conditions," Study No., 03J0011c, TOX, Jupiter, FL, USA, 26 August 2003

III. Toxikon Corporation, 2003. "SINGULAIR: Acute Toxicity to the Water Flea, Daphnia magna, Under Static Test Conditions," Study No., 03J0011a, TOX, Jupiter, FL, USA, 01 December 2003.

IV. Toxikon Corporation, 2003. "SINGULAIR: Subchonic Toxicity to the Mysid Shrimp, Mysidopsis bahia, Under Static Renewal Test Conditions ," Study No., 02J0038c, TOX, Jupiter, FL, USA, 28 May 2003.

V. Toxikon Corporation, 2003. "SINGULAIR: Acute Toxicity to Fathead Minnow, Pimephales promelas, Under Flow-Through Test Conditions," Study No., 03J0013, TOX, Jupiter, FL, USA, 10 November 2003.

VI. Smithers Viscient, 2011. " Montelukast – Early-Life Stage Toxicity Test with Fathead Minnow (Pimephales promelas) Following OECD Guideline #210," Study No., 359.6380, SV, Wareham, MA, USA, 10 June 2011.

VII. Toxikon Corporation, 1996. "Montelukast sodium (MK0476): Acute toxicity to rainbow trout: Oncorhynchus mykiss, under static test conditions"; Toxikon Environmental Sciences, Jupiter, FL, USA; 30 January 1996.

VIII. Toxikon Corporation, 2003. "SINGULAIR: Subchonic Toxicity to the Sheepshead Minnow, Cyprinodon variegatus, Under Static Renewal Test Conditions," Study No., 02J0038b, TOX, Jupiter, FL, USA, 28 May 2003.

IX. Smithers Viscient, 2011. "Montelukast – Determination of the Biodegradability of a Test Substance Based on OECD Method 301B (CO2 Evolution Test)," Study No., 359.6382, SSL, Wareham, MA, USA, 04 February 2011.

X. Toxikon Corporation, 1996. "Montelukast sodium (MK0476): Biodegradation inoculum source screening", Toxikon Environmental Sciences, 22 April 1996.

XI. Toxikon Corporation, 1996. "Montelukast Sodium (MK0746): Determination of the Rate of Hydrolysis as a Function of pH at 25oC," Study No., J9503010g, TOX, Jupiter, FL, USA, 05 June 1996.

XII. Toxikon Corporation, 1995. "Montelukast sodium (MK0476): Determination of aqueous photolysis"; Toxikon Environmental Sciences, Jupiter, FL, USA, 20 October 1995.

XIII. Smithers Viscient, 2011. "Montelukast – Determining the Partition Coefficient (n-Octanol/Water) by the Flask-Shaking Method Following OECD Guideline 107," Study No., 359.6381, SSL, Wareham, MA, USA, 18 April 2011.