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Brenoxal®

Janssen

Depotkapsel, hård 8 mg + 16 mg
Avregistreringsdatum: 2008-06-30 (Tillhandahålls ej)

Aktiv substans:
ATC-kod: N06DA04
För information om det avregistrerade läkemedlet omfattas av Läkemedelsförsäkringen, kontakta Läkemedelsförsäkringen.
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Miljöinformation

Miljöpåverkan

Galantamin

Miljörisk: Användning av galantamin har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning: Galantamin är potentiellt persistent.
Bioackumulering: Det kan inte uteslutas att galantamin kan bioackumuleras, då data saknas.


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Detaljerad miljöinformation

1. PREDICTED ENVIRONMENTAL CONCENTRATION (PEC):

The Predicted Environmental Concentration is calculated using the following formula:


PEC (µg/L) = A x 109 x (100 - R) / 365 x P x V x D x 100


Where:

A (kg/year)

=

37.23215939kg (total sold amount API in the most recent sales data for Sweden (2016) was distributed by QuintilesIMS in summer 2017)) 

R (%)

=

removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation)

 

=

0% (worst-case scenario: no removal)

P

=

number of inhabitants in Sweden (9 x 106)

V (L/day)

=

volume of waste water per capita and day

 

=

200 (ECHA default) [6]

D

=

factor for dilution of waste water by surface water flow

 

=

10 (ECHA default) [6]

PEC (µg/L)

=

0.005666995 µg/L


2. PREDICTED NO EFFECT CONCENTRATION (PNEC):

2.1. Ecotoxicological studies

2.1.1. Algae

Green algae (Selenastrum capricornutum) (OECD 201) [1]:

EbC50 72 h (biomass) > 100 mg/L

NOECb (biomass) = 10 mg/L

ErC50 72 h (growth) > 100 mg/L

NOECr (growth) = 32 mg/L


2.1.1. Crustacean

Acute

Acute Toxicity to water-flea (Daphnia magna) (OECD 202) [3]:

EC50 48 h (immobilization) = 0.44 mg/L


Chronic

Not available


2.1.1. Fish

Acute

Acute toxicity to zebra fish (Brachydanio rerio) (OECD 203) [2]:

LC50 96 h (Mortality) = 32 mg/L

NOEC (Mortality) = 10 mg/L


Chronic

Not available


2.1.1. Other ecotoxicity data

Activated sludge respiration inhibition test (OECD 209) [4]:

EC50 3 h > 1000 mg/L

NOEC = 286 mg/L


2.2. Calculation of Predicted No Effect Concentration (PNEC)

PNEC (µg/L) = lowest EC50/1000, where 1000 is the assessment factor used. EC50 for Daphnia magna (0.44 mg/L) has been used for this calculation since it is the most sensitive of the three tested species.


PNEC = 0.44 mg/L/1000 = 0.44 µg/L


2.3. Environmental risk classification (PEC/PNEC ratio)

PEC/PNEC = 0.005666995 µg/L / 0.44 µg/L = 0.012879535 i.e. PEC/PNEC ≤ 0.1


Since PEC/PNEC ≤ 0.1, Galantamine Hydrobromide has been considered to result in insignificant environmental risk.


Conclusion for environmental risk:

Use of Galantamine Hydrobromide has been considered to result in insignificant environmental risk.


3. DEGRADATION

Galantamine Hydrobromide is not readily biodegradable in a biodegradability test according to OECD No. 301 B: “Biodegradation test – CO2 evolution ” [5].


On the basis of the titration results can be concluded that Galantamine Hydrobromide is not readily biodegradable, since the pass level of 60% was not reached after an exposure period of 28 days. Consequently, the medicine is potentially persistent.


Conclusion for degradation:

Galantamine Hydrobromide is potentially persistent


4. BIOACCUMULATION

4.1 Partition coefficient octanol/water

No data available.


4.2 Bioconcentration

No data available.


Conclusion for bioaccumulation:

The potential for bioaccumulation of Galantamine Hydrobromide cannot be excluded, due to lack of data..


5. PBT-ASSESSMENT


PBT-criteria

Results for Galantamine Hydrobromide

P

DT50 freshwater > 40 days or

DT50 sediment > 120 days

-

B

BCF > 2000

-

T

Chronic NOEC < 0.01 mg/L or

CMR or endocrine disrupting

NOECalgae = 10 mg/L

NOECfish = 10 mg/L


The PBT-criteria are not fulfilled. Therefore, Galantamine Hydrobromide is not considered a PBT-substance.


6. REFERENCES

  1. Batscher R., Galantamine HBR (R0113675): Toxicity to Scenedesmus subpicatus in a 72-Hour Algal Growth Inhibition Test; RCC Study No. A35111; Janssen Study No. RMD706; February 6, 2006.

  2. Batscher R., Galantamine HBR (R0113675): Acute Toxicity to Zebra Fish (Brachydanio rerio) in a 96-Hour Static Test; RCC Study No. A35133; Janssen Study No. RMD707; February 6, 2006.

  3. Woensel M., Van Baelen S., Vos E., The Acute Toxicity of Galantamine HBr (R113675) In The Water-Flea Daphnia magna; Janssen Study No. ASKD1/0007. January 19, 1998.

  4. Büche C., Galantamine HBR (R0113675): Toxicity to Activated Sludge in a Respiration Inhibition Test; RCC Study No. A35155; Janssen Study No. RMD708; March 2, 2006.

  5. Van Baelen S., Vos E., Woensel M., The Biodegradability of Galantamine HBr (R113675) CO2 Evolution Test; Janssen Study No. BDAS/0074. November 25, 1997.

  6. 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