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Bayer

Injektionsvätska, lösning i förfylld spruta 0,25 mmol/ml
(Klar, färglös till svagt gul lösning)

Paramagnetiskt kontrastmedel

Aktiv substans:
ATC-kod: V08CA10
Läkemedel från Bayer omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan

Gadoxetinsyra

Miljörisk: Användning av gadoxetinsyra har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning: Gadoxetinsyra är potentiellt persistent.
Bioackumulering: Gadoxetinsyra 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)


Where:

A = 15,07683 kg (total sold amount API in Sweden year 2018, data from IQVIA).
R = 0 % removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation) = 0 if no data is available.

P = number of inhabitants in Sweden = 9 *106 

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

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


PEC = 0.0023 μg/L


Predicted No Effect Concentration (PNEC)

Ecotoxicological studies

Algae (Desmodesmus subspicatus):

EC50 /72 h (growth rate) = 308 mg/L
NOEC/72 h = 250 mg/L (guideline OECD 201) (1) 


Crustacean (waterflea Daphnia magna):

Acute toxicity

EC50 /48 h (immobilization) = >100 mg/L (guideline OECD 202) (2)


Fish:

Acute toxicity (Rainbow trout Oncorhychus mykiss)

LC50 /96 h (mortality) = >1000 mg/L (guideline FDA TAD 4.11) (3)

PNEC = 100 μg/L (Lowest EC50 Daphnia magna >100000 µg/L; AF 1000)


Environmental risk classification (PEC/PNEC ratio)

PEC/PNEC ratio: 0,0023/100 = 0,000023, i.e. PEC/PNEC <0,1 which justifies the phrase Use of dinatriumgadoxetat has been considered to result in insignificant risk.


Degradation

Biotic degradation

Ready degradability: not ready biodegradable


An investigation on the aerobic biodegradability of dinatriumgadoxetat in water was conducted according to OECD 301 E (4). Dinatriumgadoxetat was incubated at concentrations of 20 mg C/L given as dissolved organic carbon (DOC), equivalent to 52.5 mg/L of substance. The results showed that dinatriumgadoxetat was only marginally degraded.


Abiotic degradation

Hydrolysis:

Dinatriumgadoxetat is hydrolytically stable (diagnostic product is an aqueous solution of dinatriumgadoxetat).


Justification of chosen degradation phrase:

The lack of biotic or abiotic degradation justifies the classification: Dinatriumgadoxetat is potentially persistent in the environment.


Bioaccumulation

Partitioning coefficient:

Log POW -4.8 (pH7) (Shake flask method, OECD107) (5)


Justification of chosen bioaccumulation phrase:

Since log POW was -4.8, the substance was considered to have a low potential for bioaccumulation.

Excretion (metabolism)

“Dinatriumgadoxetat” is introduced unmetabolized as parent compound (contrast agent).


PBT/vPvB assessment

“Dinatriumgadoxetat” is not PBT/vPvB,


References

1. Growth inhibition test of ZK139834 on the green algae desmodesmus subspicatus. Schering AG, Experimental Toxicology, Report no. AY78, Study no. TXST19970088, 1997

2. Acute toxicity test with gadoxetic acid, disodium (ZK139834) with Daphnia magna, Report no. AS28, Study no. TXST19970140, 1997

3. Acute toxicity test with gadoxetic acid, disodium with the rainbow trout. Schering AG, Experimental Toxicology, Report no. AM34, Study no. TX95303, 1995.

4. Study on the biodegradability of with gadoxetic acid, disodium in the modified OECD Screening Test, no. AT67, Study no. TXST19970217, 1997.

5. Report on the physic-chemical properties of Gd-EOB-DTPA (ZK139834). Schering AG, General Physical Chemistry, Report no. L493, Study no.93/128, 1995