Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.002 mg/L

Marine water

PNEC value:
0 mg/L

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
103 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
10.3 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
83.7 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

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

Additional information

See above justifications.

Conclusion on classification

Although the test results would stricly 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 to biodegradability of the test substance.

Furthermore, an enhanced ready biodegradation test is technically not possible as the test substance is a lumpy solid which could not be well dissolved in any appropriate organic solvent.

The estimated logPow value for the substance > 10, together with the high molecular weight range of the test substance (> 700 for all components, see reference substances) indicate a limited bioavailability of the substance.

A quantitative analysis of the test substance in propylene glycol was developed and validated. However, this method is not sensitive enough for quantification of water solutions with (very) low concentrations. Therefore, any further testing to prove the lack of long-term toxicity or bioaccumulation in the aquatic environment is not deemed appropriate.

Based on the above arguments, re-classification is not performed as the safety net classification is deemed not necessary.