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 = 0.004417510611 µg/L

Where:

A = total actual API sales in Sweden for the most recent year 32.244603 kg (total sold amount API in the most recent sales data for Sweden (2022) was distributed by IQVIA in 2023)

R = 0

P = number of inhabitants in Sweden = 10 *10⁶

V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (Reference VI)

D = factor for dilution of wastewater by surface water flow = 10 (ECHA default) (Reference VI)

Predicted No Effect Concentration (PNEC)

Ecotoxicological studies

Algae (Selenastrum capricornutum) (guideline e.g. OECD 201):

Green algae (Selenastrum capricornutum) [Reference I]:

E_bC₅₀ 72 h (biomass) > 100 mg/L

NOEC_b (biomass) = 10 mg/L

E_rC₅₀ 72 h (growth) > 100 mg/L

NOEC_r (growth) = 32 mg/L

Crustacean (Daphnia magna) (water-flea) (guideline e.g. OECD 211):

Acute toxicity

Acute Toxicity to water-flea (Daphnia magna) [Reference III]:

EC₅₀ 48 h (immobilization) = 0.44 mg/L

Chronic toxicity

Not available

Fish:

Acute toxicity

Acute toxicity to zebra fish (Brachydanio rerio) (guideline e.g. OECD 203) [Reference II]:

LC₅₀ 96 h (Mortality) = 32 mg/L

NOEC (Mortality) = 10 mg/L

Chronic toxicity

Not available

Other ecotoxicity data:

Activated sludge respiration inhibition test (guideline e.g. OECD 209) [Reference IV]:

EC₅₀ 3 h > 1000 mg/L

NOEC = 286 mg/L

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

Environmental risk classification (PEC/PNEC ratio)

PEC/PNEC = 0.004417510611 µg/L / 0.44 µg/L = 0.010039797 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.

Degradation

Biotic degradation

Ready biodegradation

Galantamine Hydrobromide is not readily biodegradable in a biodegradability test according to OECD No. 301 F: “Manometric respirometry test” [Reference V].

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.

Simulation studies: 

-

Conclusion for degradation:

Galantamine Hydrobromide is potentially persistent.

Abiotic degradation

Hydrolysis: -

Photolysis: -

Bioaccumulation

Partition coefficient octanol/water [Reference VII]:

Log P = 1,39

Predicted value.

Method: ALOGPS 2.1

Bioconcentration factor (BCF):

No data available.

Conclusion for bioaccumulation: Galantamine Hydrobromide has low potential for bioaccumulation.

Excretion (metabolism)

-

PBT/vPvB assessment

	PBT-criteria	Results for Galantamine Hydrobromide
P	DT50 freshwater > 40 days or DT50 sediment > 120 days	-
B	BCF > 2000 or log Pow < 4	Log P = 1,39
T	Chronic NOEC < 0.01 mg/L or CMR or endocrine disrupting	NOECalgae = 10 mg/L

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

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

7. The Human Metabolome Database (HMDB), HMDB0014812 Human Metabolome Database: Showing metabocard for Galantamine (HMDB0014812)