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Yantil Depot

Läkemedlet är narkotikaklassatMiljöinformation
Grunenthal Sweden

Depottablett 150 mg
Avregistreringsdatum: 2013-04-30 (Tillhandahålls ej)

narkotikaindikation Beroendeframkallande medel.
Iakttag största försiktighet vid förskrivning av detta läkemedel.

Aktiv substans:
ATC-kod: N02AX06
För information om det avregistrerade läkemedlet omfattas av Läkemedelsförsäkringen, kontakta Läkemedelsförsäkringen.
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Miljöpåverkan (Läs mer om miljöpåverkan)

Tapentadol

Miljörisk: Användning av tapentadol har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning: Tapentadol bryts ned långsamt i miljön.
Bioackumulering: Tapentadol 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 = 0.04103919 μg/L

Where:

A = 273.5946 kg (total sold amount API in Sweden year 2017, data from IQVIA). 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) .

P = number of inhabitants in Sweden = 9 *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

Endpoint 

Species 

Common Name 

Method 

Time 

Result 

Ref

EC50 - based on growth rate

Pseudo-kirchneriella subcapitata

Green Algea

OECD 201

72 h

9.8 mg/L

2

EC50 - based on yield

4.5 mg/L

NOEC – based on growth rate & yield

2.4 mg/L

EC50

Daphnia magna

Water Flea

OECD 202

48 h

25 mg/L

3

NOEC

4.4 mg/L

NOEC – based on survival & reproduction

OECD 211

21 d

1.3 mg/L

4

EC50 - based on reproduction

>4.9 mg/L

LC50

Brachydanio rerio

Zebra Fish

OECD 203

96 h

77 mg/L

5

NOEC

12 mg/L

NOEC – based on early-life stage

Pimephales promelas

Fathead Minnow

OECD 210


0.53 mg/L

6

LOEC – based on early-life stage

1.0 mg/L

EC50 - based on Activated Sludge Respiration Inhibition



OECD 209

3 h

586 mg/L

7

1NOEC - based on Activated Sludge Respiration Inhibition

95.9 mg/L

EC50 - based on emergence

Chironomus riparius

Midge

OECD 218


571 mg/kg

8

NOEC - based on emergence

250 mg/kg

1Calculated as the EC15, the Effective Concentration affecting 15% of population tested


Environmental risk classification (PEC/PNEC ratio)

Long-term tests have been undertaken for species from three trophic levels, based on internationally accepted guidelines. The most sensitive species of these is the fathead minnow. Therefore, the PNEC is based on results from the assessment of the fathead minnow (Pimephales promelas) study, NOEC = 530 µg/L and an assessment factor of 10 is applied, in accordance with ECHA guidance (Ref. 9).

PNEC = 530 µg/L / 10 = 53 µg/L

PEC/PNEC = 0.04103919/53 = 0.00077432, i.e. PEC/PNEC ≤ 0.1 which justifies the phrase 'Use of tapentadol has been considered to result in insignificant risk.'


Degradation

Readily Biodegradation

Tapentadol was investigated for its ready biodegradation in a 28 day CO2 Evolution Modified Sturm Test, according to OECD Guideline 301B (Reference 10).

Based on the results of this study, tapentadol is not readily biodegradable according to the OECD Guideline 301B.


Aerobic Transformation in Aquatic Sediment Systems

Tapentadol was investigated for its aerobic degradation in a 100 day aquatic sediment test, according to OECD Guideline 308 (ref 11).

Primary degradation was observed for [14C]tapentadol in the aerobic water/sediment test samples. One major degradation product was observed at >10% of the radioactivity during the study and numerous minor degradation products (<10% of the radioactivity for individual degradates) were observed in the HPLC analyses. Ultimate biodegradation was minimally observed in the aerobic test systems. The accumulative amount of evolved 14CO2 was 0.9% of the radioactivity for the Taunton River aerobic test systems and 1.3% of the radioactivity for the Weweantic aerobic test systems at Day 101. The DT50 (half-life) for the aerobic primary degradation of [14C]tapentadol in the water layer ranged from 1.3 days to 3.3 days. The DT50 for the aerobic primary degradation of [14C]tapentadol in the water/sediment test systems ranged from 41 days to 126 days.


Anaerobic Transformation in Aquatic Sediment Systems

Tapentadol was investigated for its anaerobic degradation in a 100 day aquatic sediment test, according to OECD Guideline 308 (reference 11).

Primary degradation was observed for [14C]tapentadol in the anaerobic water/sediment test samples. Numerous minor degradation products (<10% of the radioactivity for individual degradates) were observed in the HPLC analyses. Ultimate biodegradation was minimally observed in the anaerobic test systems. The accumulative amount of evolved 14CO2 was less than 1% for the Goose River and Golden Lake anaerobic test systems at Day 101. No radioactivity was detected in the volatile organic and 14CH4 trapping systems for the anaerobic test systems at Day 101. The DT50 for the anaerobic primary degradation of [14C]tapentadol in the water layer ranged from 10.7 days to 22.8 days. The DT50 for the anaerobic primary degradation of [14C]tapentadol in the water/sediment test systems ranged from 51 days to 60 days.


Based on the data above the phrase ‘Tapentadol is slowly degraded in the environment’ is chosen.


Bioaccumulation

The n-octanol/water partition coefficient (log Kow) indicates the transfer of the active substance from the aquatic environment into organisms and a potential to bioaccumulate.

The log Kow for tapentadol is 2.89 (reference 12), which is below 4. Consequently, tapentadol has a low tendency to bioaccumulate in aquatic organisms and no bioconcentration test is required and the statement 'Tapentadol has low potential for bioaccumulation' is assigned.


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. Tapentadol HCl - Acute Toxicity to the Freshwater green alga, Pseudokirchneriella subcapitata. OECD Guideline 201.

  3. Tapentadol HCl – full life-cycle toxicity test with water fleas, Daphnia magna, under static-renewal conditions. OECD Guideline 211. Grünenthal R&D, 2007.

  4. Tapentadol HCl – acute toxicity to water fleas, (Daphnia magna), under static conditions, following OECD draft guideline 202. Grünenthal R&D, 2007.

  5. Tapentadol HCl – acute toxicity to zebra fish (Brachydanio rerio), under static-renewal conditions. OECD Guideline 203. Grünenthal R&D, 2007.

  6. Tapentadol HCl – early life-stage toxicity test with fathead minnow, (Pimephales promelas), following OECD guideline 210. Grünenthal R&D, 2007.

  7. Tapentadol HCl – activated sludge respiration inhibition. OECD Guideline 209.

  8. Tapentadol: Sediment-Water Chironomus riparius Toxicity Test using Spiked Sediment. OECD Guideline 218. Grünenthal R&D, 2010.

  9. ECHA, European Chemicals Agency. May 2008. Guidance on Information Requirements and Chemical Safety Assessment. Chapter R.10: Characterisation of dose [concentration]-response for environment http://echa.europa.eu/documents/10162/13632/information_requirements_r10_en.pdf

  10. Tapentadol HCl – determination of the biodegradability based on OECD method 301B (CO2 evolution test). Grünenthal R&D, 2007

  11. Tapentadol HCl – aerobic and anaerobic transformation in aquatic sediment systems following OECD guideline 308. Grünenthal R&D, 2007.

  12. Tapentadol HCl (R331333) Ionization Constants and Lipophilicity Report