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