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MiljöinformationReceptstatusFörmånsstatus
MSD

Gel 0,05 %
Avregistreringsdatum: 2017-12-31 (Tillhandahålls ej) (vit gel)

Extra starkt glukokortikoidpreparat (Grupp IV)

Aktiv substans:
ATC-kod: D07AC01
För information om det avregistrerade läkemedlet omfattas av Läkemedelsförsäkringen, kontakta Läkemedelsförsäkringen.
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Miljöpåverkan (Läs mer om miljöpåverkan)

Betametason

Miljörisk: Användning av betametason har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning: Betametason är potentiellt persistent.
Bioackumulering: Betametason 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 = 0.01 μg/L


Where:

A = 66 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 (growth rate and yield) > 34 mg/L

NOEC 72 h (growth rate and yield) = 34 mg/L


Crustacean, water flea (Daphnia magna) (OECD 211) (Ref. III):

Chronic toxicity

NOEC 21 d (parental survival) = 17 mg/L

NOEC 21 d (reproduction and growth) > 8 mg/L


Fish, fathead minnow (Pimephales promelas) (OECD 210) (Ref. IV):

Chronic toxicity

NOEC 32 d (mean dry weight) = 0.052 mg/L


PNEC = 5.2 μg/L (52 µg/L / 10 based on the most sensitive chronic NOEC for the fathead minnow and an assessment factor (AF) of 10)


Environmental risk classification (PEC/PNEC ratio)

PEC/PNEC = 0.01/5.2 = 0.002, i.e. PEC/PNEC ≤ 0.1 which justifies the phrase "Use of betamethasone has been considered to result in insignificant environmental risk.”


Degradation

Biotic degradation

Ready degradability (OECD 302B/314B) (Ref. V):

The biodegradation of [3H]betamethasone was studied at a concentration of approximately 10 mg C/L and a temperature of 22 ± 2 ºC for 28 days in activated sludge. Activated sludge samples were analyzed at time zero, 1, 3, 7, 14, 21 and 28 days after dosing to determine primary biodegradation.


The radioactive distribution of parent [3H]betamethasone in biotic sludge decreased from 101.8% AR on Day 0 to 22.0% AR on Day 14 and then was not detected through Day 28, as measured in the biotic sludge extract by the HPLC/RAM detector. The half-life of [3H]betamethasone in the biotic sludge system was determined by first order linear regression, using data through Day 14, to be 6.2 days.


Betamethasone underwent 40% degradation in 7 days and 78% degradation by day 14.


Justification of chosen degradation phrase:

78% degradation of betamethasone was observed in the OECD 302B/314B study within 14 days but it does not pass the criteria of inherent biodegradability. The phrase “The medicine is potentially persistent” is thus chosen.


Bioaccumulation

Partitioning coefficient (OECD 107) (Ref.VI):

Log Kow = 2.11 at pH 7


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. Smithers Viscient, 2012. "Betamethasone – 72-Hour Acute Toxicity Test with Freshwater Green Alga, Pseudokirchneriella subcapitata, Following OECD Guideline 201," Study No. 359.6621, SV, Wareham, MA, USA, 03 August 2012.

  3. Smithers Viscient, 2012. "Betamethasone – Full Life-Cycle Toxicity Test with Water Fleas, Daphnia magna, Under Static Renewal Conditions Following OECD Guideline #211," Study No. 359.6623, SV, Wareham, MA, USA, 07 December 2012.

  4. Smithers Viscient, 2013. "Betamethasone – Early Life-Stage Toxicity Test with Fathead Minnow, Pimephales promelas, Following OECD Guideline #210," Study No. 359.6622, SV, Wareham, MA, USA, 23 January 2013.

  5. Smithers Viscient, 2013. "[3H]Betamethasone – Determination of the Biodegradability of a Test Substance Based on OECD Guideline 302B and OECD Guideline 314B," Study No. 359.6659, SV, Wareham, MA, USA, 19 July 2013.

  6. Smithers Viscient, 2012. "Betamethasone - Determining the Partition Coefficient (n-Octanol/Water) by the Flask-Shaking Method Following OECD Guideline 107," Study No. 359.6620, SV, Wareham, MA, USA, 08 August 2012.