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Clarityn®

MiljöinformationReceptstatusFörmånsstatus
Bayer

Tablett 10 mg
(vit till benvit, oval tablett märkt med kolv och skål, skåra och "10" på en sida, slät på den andra sidan)

Antihistamin H1-antagonist

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ATC-kod: R06AX13
Läkemedel från Bayer omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöpåverkan (Läs mer om miljöpåverkan)

Loratadin

Miljörisk: Användning av loratadin har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning: Loratadin är potentiellt persistent.
Bioackumulering: Loratadin 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 = 0.0862 μg/L

Where:

A = 574.74 kg (total sold amount API in Sweden year 2017, data from IQVIA).
R = 0 % removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation) = 0 if no data is available.

P = number of inhabitants in Sweden = 9 *106 

V (L/day) = volume of waste water per capita and day = 200 (ECHA default) (1)

D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (1)


Predicted No Effect Concentration (PNEC)

Ecotoxicological studies

Algae (Pseudokirchneriella subcapitata)

NOEC /72h (growth rate) = 0.053 mg/L, LOEC /72h (growth rate) = 0.12 mg/L (guideline OECD 201) (2)

Crustacean (waterflea Daphnia magna):

Acute toxicity

EC50 /48 h (immobilization) = 3.1 mg/L NOEC /48h (immobilization) = 0.098 mg/L (guideline FDA TAD 4.08) (3)
EC50 /48 h (immobilization) = 0.83 mg/L NOEC /48h (immobilization) = 0.3 mg/L (guideline OECD 202) (4)

Chronic toxicity

NOEC /21d (reproduction) = 0.078 mg/L, LOEC /21d (reproduction) = 0.2 mg/L (guideline OECD 211) (5)

Fish

Acute toxicity (Bluegill sunfish Lepomis macrochirus)

LC50/96h = 0.38 mg/L (guideline OECD 203) (6)

Chronic toxicity (Fathead minnow Pimephales promelas)

NOEC /28d post-hatch (hatch, mortality, growth) = 0.084mg/L, LOEC /28d post-hatch (hatch, mortality, growth) = 0.17 mg/L (guideline OECD 210) (7)

Activated sludge microorganisms inhibition test

NOEC /3h ≥ 1000 mg/L, LOEC /3h > 1000 mg/L (guideline OECD 209) (8)

PNEC = 5.3 µg/L (Lowest chronic NOEC algae = 53 µg/L; AF 10)

Environmental risk classification (PEC/PNEC ratio)

PEC/PNEC ratio: 0.0826/5.3 = 0.016, i.e. PEC/PNEC <0.1 which justifies the phrase Use of loratadine has been considered to result in insignificant environmental risk.


Degradation

Biotic degradation

Ready degradability: not readily biodegradable.


Simulation tests to assess the biodegradability of chemicals discharged in wastewater guideline OECD 314B, using C-14 labelled test material (9). Single test vessels were prepared for the biotic, abiotic and positive control definitive study by adding 500 mL of sludge inoculum (the activated sludge used as the inoculum for this study was obtained from a wastewater treatment plant dealing primarily with domestic sewage) directly into 500-mL amber bottles. The biotic inoculum was used for the test substance and positive control vessels and the sterilized sludge was used for the abiotic control vessel. Each test vessel was capped with a silicone stopper fitted with a glass tube inlet and a glass tube outlet for air exchange.

The biotic and abiotic test vessels were dosed with [14C]loratadine test material at a target concentration of 0.50 mg/L. The biotic and abiotic test vessel received 0.270 mL of the 0.930 mg/mL [14C]loratadine radiolabeled stock solution.

The reference test vessel was dosed with [14C]sodium benzoate reference material at a target concentration of 1.0 mg/L. The reference test vessel received 0.045 mL of the 11.4 mg /mL[14C]sodium benzoate stock solution. Following dosing, the biotic, abiotic and reference test vessels were placed on separate aeration systems (approximately 50 cc/minute). The test vessels were mixed and aerated to sufficiently suspend the solids in the test solution and maintain dissolved oxygen above 2.0 mg O2/L. Test vessels were incubated in an environmental chamber at 22 ± 2 ºC in the dark within the environmental chamber. [14C]Loratadine concentrations decreased from the initial concentration of 0.501 mg/L to 0.191 mg/L on day 28. This represents a primary biodegradation value of 62.0%. in 28 days. The half-life (DT50) was calculated for the biotic sludge. The overall primary biodegradation half-life after 28 days in the biotic sludge was calculated to be 20.32 days. The overall elimination rate constant, ke, was 0.0341 days-1.


A further test was conducted according to OECD 308 (aerobic aquatic-sediment transformation test) (10). C-14 labeled loratadine was added, at a concentration of approximately 0.5 mg/L, to sediment/water systems obtained from two aerobic sources and incubated at 20 ± 2 ºC in glass metabolism vessels for 101 days. Sampling intervals for the study were 0, 3, 14, 28, 56 and 102 days. The water and sediment extracts were radioassayed and analyzed by high performance liquid chromatography (HPLC) to determine the amount of [C-14]loratadine and degradates in the fractions. Sediment-bound residues were determined by oxidative combustion analysis. The KOH and volatile organic traps were radioassayed directly by liquid scintillation counting. Evidence of primary biodegradation was observed for [C-14]loratadine in the aerobic water/sediment test samples. Several minor regions of radioactivity were observed in some of the chromatograms. In all cases, these peaks represented less than 10% radioactivity and were not considered further. Ultimate biodegradation was observed in the aerobic test systems. The half-life of [14C]loratadine in the water ranged from 13 to 20 days for the aerobic test systems. The half-life of [14C]loratadine in the total water/sediment test systems ranged from 217 to 301 days for the aerobic test systems.


Abiotic degradation

Hydrolysis:

Hydrolytically stable (test guideline FDA TAD 3.09) (11).


The biotic degradation half-life of 217 to 301 days justifies the phrase: Loratadine is potentially persistent, in accordance with the half-life criterion developed for the aquatic-sediment study OECD 308.


Bioaccumulation

Partitioning coefficient:

Log POW 2.38 (pH 5), 2.33 (pH 7), 2.0 (pH 9) (FDA TAD 3.02) (12)

The log Pow of 2.0 to 2.38 justifies the phrase: Loratadine has a low potential for bioaccumulation.


Loratadine is not PBT/vPvB.


Excretion (metabolism)

Loratadine is metabolized to the active molecule Desloratadin, excretion occurs mainly in the metabolized form (conjugated).


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. Loratadine – 72-Hour Acute Toxicity Test with Freshwater Green Alga, Pseudokirchneriella subcapitata, following OECD Guideline 201., Springborn Smithers Study No. 359.6397, Merck & Company (2011)

  3. SCH 29851-Acute toxicity to Daphnia magna under static conditions. Springborn study no. 1560.0592.6192.110, Schering-Plough, report no. P-5773 (1993)

  4. SCH 29851-Acute toxicity to Daphnia magna. Huntingdon Life Science study no. ESN034/993311, Schering-Plough (2000)

  5. Loratadine – Full Life-Cycle Toxicity Test with Water Fleas, Daphnia magna, Under Static-Renewal Conditions, Following OECD Guideline #211, Springborn Smithers Study No. 359.6398, Merck & Company (2011)

  6. SCH 29851-Acute toxicity to Bluegill sunfish. Huntingdon Life Science study no. ESN034/993644, Schering-Plough (2000)

  7. Loratadine – Early Life-Stage Toxicity Test with Fathead Minnow, Pimephales promelas, following OECD Guideline #210, Springborn Smithers Study No. 359.6399, Merck & Company (2011)

  8. Loratadine – Activated Sludge Respiration Inhibition Test following OECD Guideline 209, Springborn Smithers Study No. 359.6400, Merck & Company (2011)

  9. [14-C]Loratadine – Determination of the Biodegradability of a Test Substance in activated Sludge Based on OECD Method #209, Springborn Smithers Study No. 359.6391, Merck & Company (2011)

  10. [14C]Loratadine – Aerobic Transformation in Aquatic Sediment Systems Following OECD Guideline 308. Springborn Smithers Study No. 359.6395, Merck & Company (2011)

  11. SCH 29851-Determination of aqueous hydrolysis rate constant and half-life. Springborn study no. 1560.0192.6179.715, Schering-Plough (1993)

  12. SCH 29851-Determination of the n-octanol/water partition coefficient , Springborn study no. 1560.0192.6178.705, Schering-Plough (1992)