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LEO Pharma

Kutant skum 50 mikrogram/g + 0,5 mg/g
(Kutant skum. Efter sprayning bildas ett vitt till benvitt skum.)

Medel vid psoriasis. Övriga medel vid psoriasis för utvärtes bruk, kalcipotriol, kombinationer.

ATC-kod: D05AX52
Läkemedel från LEO Pharma omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöpåverkan (Läs mer om miljöpåverkan)

Betametason

Miljörisk: Risk för miljöpåverkan av betametason kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning: Det kan inte uteslutas att betametason är persistent, då data saknas.
Bioackumulering: Betametason har låg potential att bioackumuleras.


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Detaljerad miljöinformation

Environmental risk classification


Predicted Environmental Concentration (PEC)

The predicted environmental concentration is calculated according to the following formula:

PEC (µ/L) = (A×109×(100-R))/(365×P×V×D×100) = 1.5×10-6×A(100-R)

PEC = 0.010 µg/L


Where:

A = 65.63 kg (total sold amount API (independent of betamethasone derivative) in Sweden year 2015, data from IMS Health). Reduction of A may be justified based on metabolism data.

R = 0 % removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation) = 0 if no data is available. (If R‡ 0 this should be justified under the degradation section).

P = number of inhabitants in Sweden = 9×106.

V (L/day) = volume of wastewater per capita and day = 200; ECHA default value [ECHA, 2016].

D = factor for dilution of wastewater by surface water flow = 10; ECHA default value [ECHA, 2016].


Measured environmental concentrations

To our knowledge, no measured environmental concentrations exist.


Predicted no-effect concentration (PNEC)

According to the Hazardous Substance Data Bank (HSDB) [TOXNET, 2016] and US EPA ECOTOX Knowledgebase [US EPA, 2016], no ecotoxicological studies have been performed for betamethasone dipropionate and also not for betamethasone.


Environmental risk classification (PEC/PNEC ratio)

Risk of environmental impact of bethamethasone dipropionate (or betamethasone) cannot be excluded, since no ecotoxicity data are available.


Degradation


Biotic degradation

According to a screening test for ready biodegradability (the OECD 301F ready biodegradability – manometric respiromety test) only 17% biological oxygen demand (BOD) was obtained, resulting in betamethasone dipropionate not being classified as ready biodegradable [Winther-Nielsen, 2016]. However, this fraction of BOD corresponds more or less to biodegradation of the two ester groups in betamethasone dipropionate, resulting in degradation to free betamethasone, for which no data exist, to the best of our knowledge.


Abiotic degradation

Based on the structure of betamethasone dipropionate it is expected to undergo hydrolysis of the two ester groups resulting in free betamethasone.

The medicine is potentially persistent.


Bioaccumulation

Based on the experimental log KOW value of 4.07 [Hansch et al., 1995], betamethasone dipropionate has high potential for bioaccumulation. However, the experimental log KOW value for betamethasone is only 1.94 [Hansch et al., 1995], indicating a substance with low potential for bioaccumulation.


Based on the experimental log KOW value for betamethasone dipropionate, an estimated bioconcentration factor (BCF) of 225 was found [US EPA, 2012].


Unless biodegraded or hydrolyzed, the parent compound betamethasone dipropionate has high potential for bioaccumulation, whereas the suggested main degradation product betamethasone has low potential for bioaccumulation.


Other environmental fate processes

No other relevant information.


Excretion (metabolism)

No other relevant information.


PBT/vPvB assessment

Based on the experimental ready biodegradability data, the experimental log KOW value and the estimated BCF-value, there is no indication that betamethasone dipropionate or betamethasone should be neither PBT nor vPvB.


References:

Hansch, C., Leo, A., D. Hoekman. Exploring QSAR - Hydrophobic, Electronic, and Steric Constants. Washington, DC: American Chemical Society., 1995.


ECHA, European Chemicals Agency. 2016. Guidance on information requirements and chemical safety assessment – Chapter 16: Environmental exposure assessment (https://echa.europa.eu/documents/10162/13632/information_requirements_r16_en.pdf)


TOXNET, United States National Library of Medicine, 2016. HSDB: https://toxnet.nlm.nih.gov/cgi-bin/sis/search2/f?./temp/~sjLqWi:3


US EPA, United States Environmental Protection Agency, 2012. Estimation Program Interface (EPI) Suite. Ver. 4.11. Available from: https://www.epa.gov/tsca-screening-tools/download-epi-suitetm-estimation-program-interface-v411


US EPA, United States Environmental Protection Agency, 2016. US EPA ECOTOX Knowledgebase: https://cfpub.epa.gov/ecotox/ 


Winther-Nielsen, M. (2016): Ready biodegradability – Manometric respirometry test with Betamethasone dipropionate. Report to: LEO Pharma A/S. DHI Denmark. Report No. 11818871. GLP Study No. 051-1109. 2016.05.17


Kalcipotriol (vattenfri)

Miljörisk: Risk för miljöpåverkan av kalcipotriol kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning: Kalcipotriol är potentiellt persistent.
Bioackumulering: Kalcipotriol har hög potential att bioackumuleras.


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Detaljerad miljöinformation

Environmental risk:

The total sale of active ingredient calcipotriol in Sweden 2014 was according to IMS Health (anhydrate + monohydrate) 47.34 kg. This cannot be correct as it is more than 50% of the total production of calcipotriol worldwide. It is likely that there is a factor 100 error and the actual sale of calcipotriol is 0.4734 kg. Anyway we have used the 47.34 kg in our calculations.

PEC = 1.5 x 10-6 x 47.34 x (100-0) = 0.007 µg/L

Experimental ecotoxicity data for algae, daphnia and fish are not available. Because of the lack of data it is not possible to calculate a valid PNEC and a risk of environmental impact cannot be excluded.


Degradation:

Calcipotriol is not readily biodegradable. It has been tested according to the test guideline OECD 301F and a biodegradation of -2 ± 2% was found after 28 days. (Winther-Nielsen, OECD 301F, DHI Water & Environment, 2007) [1]. Calcipotriol is therefor is potentially persistent.


Bioaccumulation:

LogPow, calcipotriol = 4.9 (Lolansen, B., Calcipotriol (MC 903) Octanol/Water Partition Coefficient, LEO Pharma A/S, 2007) [2]

As LogPow > 4 the following phrase applies: “Calcipotriol has high potential for bioaccumulation.”


References:

1. Winther-Nielsen, OECD 301F, DHI Water & Environment, 2007

2. Lolansen, B., Calcipotriol (MC 903) Octanol/Water Partition Coefficient, LEO Pharma A/S, 2007