Registration Dossier

Administrative data

Hazard for aquatic organisms

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
10 mg/L
Assessment factor:
10

Hazard for air

Hazard for terrestrial organisms

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
33.3 mg/kg food
Assessment factor:
300

Additional information

Conclusion on classification

Although the test results would strictly fit the criteria for R53/H413 environmental classification, it is our opinion that this classification is not applicable for this substance. Please find below our weight-of-evidence reasoning:

 

As stated in section 5.2.1, the results of the Modified Sturm test cannot be interpreted because the tested concentration was far above the maximum water solubility. Thus, in view of lack of the optimal contact between the test substance and the medium in the test, no definitive conclusions can be drawn with respect of biodegradability of the test substance.

 

Furthermore, an enhanced ready biodegradation test is technically not possible as the

test substance is a granular solid which could not be dissolved in any common organic solvent or mixtures of solvents.

 

The estimated logPow value for several SMILES of substance components representatives > 10, together with the very high molecular weight distribution of the test substance (Mn = 1927, Mw = 2161, PDI = 1.12, see reference substance) indicate a limited bioavailability of the substance.

 

Because no quantitative analysis of the test substance in water or corn oil could be developed or validated (see section 8), any further testing to prove the lack of long-term toxicity or bioaccumulation in the aquatic environment is not deemed appropriate.