Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.1 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
1 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.01 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
1 mg/L

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
10 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

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

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

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

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Aquatic toxicity potential of the test item was calculated using assessments of potential hazard of the test item to aquatic organisms (freshwater, marine water, sewage treatment plant (STP), freshwater sediment and marine sediment), air, terrestrial organisms (soil) and predators (via secondary poisoning).

In order to assess freshwater and marine water hazard, the following data was obtained from short-term studies on the test item over three trophic levels:

- Short-term toxicity to fish: LC50> 100 mg/L (nominal) (Poecilia reticulata, 96 h)

- Short-term toxicity to aquatic invertebrates: EC50> 100 mg/L (nominal) (Daphnia magna, 48 h)

- Toxicity to aquatic algae: ErC50> 100 mg/L (nominal) (Desmodesmus subspicatus, 72 h)

The same effect concentrations were reported for all three trophic levels, therefore, it was not necessary to determine one most sensitive species, and the common value of 100 mg/L was therefore used in order to calculate the freshwater and marine water risk. The PNECfreshwater value was found to be 0.1 mg/L; the PNECmarine water value was found to be 0.01 mg/L. It should be noted that the concentration of the test item in water was not analysed in any of the three tests, therefore, nominal concentrations only were used for interpretation.

In order to assess STP hazard, the following data was obtained from a respiration inhibition test:

- Toxicity to microorganisms: EC50 (3 h) > 1000 mg/L

The PNECmicroorganisms value using the effect concentration of 1000 mg/L was found to be 10 mg/L.

Hazards to freshwater and marine water sediment were calculated using the equilibrium partitioning method due to the absence of experimental studies on sediment. The following equations were applied:

PNECfreshwater sediement = Ksusp-water / RHOsusp * PNECfreshwater * 1000

PNECmarine water sediement = Ksusp-water / RHOsusp * PNECfreshwater * 1000

Hazard to terrestrial organisms was also calculated using the equilibrium partitioning method due to the absence of experimental studies on soil organisms. The following equation was applied:

PNECsoil = Ksoil-water / RHOsoil * PNECfreshwater * 1000

In order to determine the Ksusp-water/Ksoil-water and RHOsusp/RHOsoil values, the EUSES software was utilised which required certain physicochemical properties of the substance. The molecular weight of the test item was approximated, as it is an UVCB substance, using the mean of the largest and smallest structures identified in an analytical report of the test item (molecular weight (g/mol) = (205.809 + 394.4)/2). Additionally, the vapour pressure was interpreted to be the lowest possible value of 1-6 Pa at 25 °C, and, as the true water solubility value was found to be higher than the highest accepted value, the highest value of 100 g/L at 25 °C was utilised.

PNECsediment (freshwater) was calculated to be 0.1264 mg/kg of sediment (dry weight); PNECsediment (marine water) was calculated to be 0.01264 mg/kg sediment (dry weight).

PNECsoil was calculated to be 0.0196 mg/kg soil (dry weight).

Biotic and abiotic hazards for air were not considered as the vapour pressure of the test item is negligible. Hazard for predators (via secondary poisoning) was not considered as the test item is not considered to bioaccumulate.

Conclusion on classification