Registration Dossier

Diss Factsheets

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:
2.9 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
20 000 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
2 000 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:
2 400 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

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

Additional information

Conclusion on classification

The substance was classified as Chronic Category 4. The acute toxicity data (each L(E)C50 value > 100 mg/L) indicate that no acute toxicity was observed up to the level of solubility (9.0 mg/L – 69.4 mg/L at 20.0 ± 0.5oC at loading rates ranging from 100 mg/L – 1000 mg/L). The substance was not shown to be readily biodegradable, but the rate of biodegradation (41% in 28 days) was indicative of inherent biodegradability and substantial mineralisation. The octanol-water partition coefficient could not be experimentally determined, but the value for an ester representative of a low-molecular weight constituent of the UVCB substance has been estimated by modeling to be log Kow = 9.96, which exceeds the criterion of log Kow ≥ 4, indicative of the potential for bioaccumulation. With respect to the uncertainty associated with its solubility and partitioning behaviour, this substance was conservatively assigned an environmental hazard classification of Chronic Category 4. Therefore, the substance is assigned the associated hazard statement H413 (“May cause long lasting harmful effects to aquatic life”), and may be assigned the precautionary statements P273 (“Avoid release into the environment”), P391 (“Collect spillage”) and P501 (“Dispose of contents/container to…”).