Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
3.2 µg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

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:
1.29 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

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

Hazard for air

Hazard for terrestrial organisms

Soil

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

Hazard for predators

Additional information

The following effect data are available for the submission substance:

1) Short term toxicity test on Cyprinus carpio:

NOEC = 100 mg/L (nominal concentration)

LC50 > 100 mg/L (nominal concentration)

2) Acute toxicity test on Daphnia magna:

NOEC (48h): 32 mg/L (nominal concentration)

EC50 (48h): 32 -56 mg/L (nominal concentration)

3) Toxicity test on freshwater algae (Pseudokirchnerella subcapitata)

Growth rate reduction (72h):

NOEC = 3.2 mg/L (nominal concentration)

EC50 >100 mg/L (nominal concentraion)

4) Toxicity to microorganisms (activated sludge respiration inhibition)

EC50 (3h) >100 mg/L (nominal concentration)

In the studies on aquatic toxicity only a small fraction of the loading rate was dissolved. As shown by measured TOC values test substance concentrations increased with increasing loading rates and were stable throughout the test. From this it can be concluded that only a small fraction (the "more water soluble fraction") of this UVCB substance is solved in water and that its concentration in water is depending on the total amount of substance provided to the water phase. As it is reasonable to assume that this solved fraction is available to aquatic organisms and is responsible for the aquatic toxicity observed, the nominal concentrations (loading rates) are used to characterise the observed toxicity.

The most sensitve endpoint is therfore acute toxicity to Daphnia magna with an EC50 (48h) of 32 - 56 mg/L (nominal concentration). Some effects are seen on algal growth rate. For fish and microorganisms, no effects could be observed at the applied limit concentration of 100 mg/L nominal. Therefore, PNECs were derived based on the effect value obtained for Daphnia magna.

According to the REACH guidance on information requirements and chemical safety assessment part R.7A, "substances with a Koc below 500 -1000 L/kg are generally unlikely to adsorb zu sediment". As the Koc-value (calculated) determined as result of a weight of evidence approach for the UVCB submission substance is 366.4 L/kg, partitioning to sediment and soil is most probably of minor importance. The derived PNECs for sediment and soil wet weight (34.1 and 25.7 µg/kg, respectively) are about one order of magnitude higher than the PNECaqua.

Conclusion on classification

The most sensitive endpoint for the submission substance is acute toxicity to Daphnia magna with an EC50 (48h) of 32 - 56 mg/L (nominal concentration). The submission substance is not readily biodegradable (26.5% biodegradation as average of duplicate samples within 28 days).

Therefore, the submission substance is classified according to Regulation 1272/2008 EC as

Hazardous to the aquatic environment: Chronic Category 3 (H412)

Therefore, the submission substance is classified according to directive 67/548 EC with R52/R53

Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment.