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Aspen Nordic

Tablett 40 mg
(vita till benvita tabletter, runda, bikonvexa med skåra och präglade med T40 på ovansidan, utan skåra och prägling på undersidan)

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Delbarhetsinformation

Cytostatikum

Aktiv substans:
ATC-kod: L01BB03
Utbytbarhet: Utbytbara läkemedel
Läkemedel från Aspen Nordic omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan

Tioguanin

Miljörisk: Risk för miljöpåverkan av tioguanin kan inte uteslutas då det inte finns tillräckliga ekotoxikologiska data.
Nedbrytning: Tioguanin är potentiellt persistent.
Bioackumulering: Tioguanin har låg potential att bioackumuleras.


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Detaljerad miljöinformation

Predicted Environmental Concentration (PEC)


PEC is calculated according to the following formula:


PEC (μg/L) = (A*109 *(100-R))/(365*P*V*D*100) = 1.37*10-6 *A(100-R)


PEC = 1.39 10-4 μg/L


Where:

A = 1,015 kg (total sold amount API in Sweden year 2021, data from IQVIA.)

R = X % removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation) = 0 if no data is available. R=0

P = number of inhabitants in Sweden = 10*106

V (L/day) = volume of wastewater per capita and day = 200 (ECHA default)(Ref.1)

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


Predicted No Effect Concentration (PNEC)

Ecotoxicological Studies

Green alga, Scenedesmus subspicatus

EC50 = 3.4 ug/L (OECD 201)

NOEC = 0.5 ug/L


Water flea, Daphnia magna:

EC50 48h = 16 500, ug/L (OECD 202)

NOEC 48h = 4 900, ug/L


Microorganisms in activated sludge

EC50 3h > 1 000 000, ug/L (OECD 209)


Mouse (oral): LC50 = 160 mg/kg (Ref. 2,3)


A PNEC cannot be calculated because data is not available for all three (algae, crustacean and fish) of the short-term toxicity endpoints.


Environmental risk classification (PEC/PNEC ratio)

Risk of environmental impact of remifentanil cannot be excluded, since there is not sufficient ecotoxicity data available.


Degradation

Results of biological degradation:

Ready Biodegradation = 5% in 28 days (FDA TAD 3.11)

Inherent biodegradation = 68% in 28 days (OECD 302B).

The medicine is potentially persistent.


Results of abiotic degradation:

Hydrolysis

Half-life, pH 7 = 62 days (OECD 111)


Bioaccumulation

Log Kow = - 0.07 (Ref 3)

Since log Kow < 4 at pH 7, the substance has low potential for bioaccumulation.



Excretion (Metabolism)

Only trace amounts of thioguanine are found in the urine. Thioguanine is catabolised to inactive metabolites 6-thioxanthine and 2-amino-6-methythiopurine (MTG). MTG is the principle metabolite excreted in urine (ref 4).


Other Hazard Notation

The compound may be:

  • Acute toxicity (any route of exposure)

  • Respiratory or skin sensitization

  • Germ cell mutagenicity

  • Carcinogenicity

  • Reproductive toxicity

According to SARA 311/312 Hazardous chemical list (Ref 3)



References:

  1. [ECHA] European Chemicals Agency. December 2022. Guidance on Information Requirements and Chemical Safety Assessment. Chapter R.16: Environmental exposure assessment (version 3.0)

  2. British Pharmacopoeia, Safety Data Sheet according to 1907/2006/EC, Article 31, Allopurinol, Revision 02.12.2013

  3. Aspen Global Incorporated, Safety Data Sheet, Tiogaunine 40 mg tablets, version 2.0, revision 05.01.2018

  4. Brox LW, et al, Cancer Chemother Pharmacol 6: 35-38, 1981.

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