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) = 1.37*10^-6*A*(100-R) = 0.15 μg/L

Where:

A = 958.32 kg (meglumine salt) + 145.2 kg (sodium salt) = 1103.52 kg (total sold amount API in Sweden year 2021, data from IQVIA / LIF)

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 = 10 *10⁶

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

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

Predicted No Effect Concentration (PNEC)

Ecotoxicological studies

Both studies detailed below were conducted with the amidotrizoate meglumine salt.

Crustacean (waterflea, Daphnia magna):

Acute toxicity

EC₅₀ 48 hours (immobilization) ≥ 100 mg/L. Guideline OECD 202. (Reference II)

Bacteria (Pseudomonas putida)

EC₅₀ 16 hours (growth) > 1000 mg/L. Guideline DIN38412 L8. (Reference III)

The available ecotoxicological data is insufficient for PNEC derivation.

Environmental risk classification (PEC/PNEC ratio)

Due to limited ecotoxicological data it is not possible to derive the risk quotient (PEC/PNEC).

Justification of chosen environmental risk phrase:

Insufficient data to calculate the PEC/PNEC ratio qualifies for the phrase “Risk of environmental impact of amidotrozoic acid cannot be excluded, since there is not sufficient ecotoxicity data available.”

Degradation

Biotic degradation

Ready degradability:

The test compound (meglumin amidotrizoate) was studied for ready biodegradability in a test conducted over 28 days. Total biodegradation reached 19 % at day 3 and was attributed to meglumine, as specific chemical analysis of amidotriazoate did not reveal any biodegradation. Hence, the study reported 0 % biodegradation of amidotrizoic acid in 28 days. Guideline OECD 301E. (Reference IV)

Justification of chosen degradation phrase:

Amidotrozoic acid was assessed to be not readily biodegradable, which qualifies for the phrase “Amidotrozoic acid is potentially persistent.”

Bioaccumulation

Partitioning coefficient:

The partitioning coefficient of amidotrizoic acid was reported in the pubchem database as estimated with the US EPA EPI Suite, v4.1.

The log D_ow was reported with 1.37 (Reference V)

Justification of chosen bioaccumulation phrase:

As the log D_ow was < 4 amidotrozoic acid is not considered bioaccumulative which qualifies for the phrase “Amidotrozoic acid has low potential for bioaccumulation.”

Excretion (metabolism)

Amidotrizoate meglumine/sodium salt is excreted unmetabolized as the parent compound. (Reference VI).

References

1. Guidance on information requirements and Chemical Safety Assessment Chapter R.16: Environmental exposure assessment. V3.0, Feb. 2016.

2. Acute immobilization test of ZK2336/Megl. to Daphnia magna (limit test). Schering AG, Experimental Toxicology, Report no. 8944, Study no. TX89378.

3. Growth inhibition test of meglumin amidotrizoate on the bacterium Pseudomonas putida. Schering AG, Experimental Toxicology, Report no. 9193, Study no. TX90151.

4. Study on the biodegradability of meglumin amidotrizoate, iohexol and iopromid according to the modified OECD Screening Test. Schering AG, Experimental Toxicology, Report no. 9170, Study no. TX90105.

5. Pubchem database. LogP estimation of amidotrizoic acid based on US EPA EPI Suite, v4.1.

6. Bourin M, Jolliet P, Ballereau F. An overview of the clinical pharmacokinetics of x-ray contrast media. Clin Pharmacokinet Mar;32(3):180-93.