Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
5 450 ng/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
545 ng/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:
1 089 ng/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

It should be noted that a loading rate of 100 mg/L did not cause any toxicity in fish, aquatic invertebrates and algae. This is probably due to the very low solubility of FAT 41043/A TE in water, which means that concentration levels that might be toxic could not be reached.

Conclusion on classification

A loading rate of 100 mg/L did not cause any toxicity in fish, aquatic invertebrates and algae. This is probably due to the very low solubility of FAT 41043/A TE in water, which means that concentration levels that might be toxic could not be reached. The NOEC algae of 21 ng/L(TWA), being a chronic toxicity endpoint, is assumed to be > the water solubility; this results in no need for environmental classification.

Under the DSD Regulation, the substance should be classified as R53 as the NOEC algae, being the only chronic toxicity endpoint, cannot be used as additional scientific evidence for waiving environmental classification.