Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)

STP

Hazard assessment conclusion:
no emission to STP expected

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

Additional information

The submission substance showed neither effects on aquatic algae nor on fish or daphnia: L(E)L 50 acute (fish, daphnia, alga) >100 mg/L (loading rate), corresponding to 55.1 mg/L of submission substance.This concentration is considered to be high above the water solubility of the submission substance and it can be concluded that no adverse effects were observed up to the water solubility limit. Also, the substance and its ligand TTP rapidly hydrolyse. Therefore, no meaningful PNECs can be derived from the data. The substance proved to be nontoxic to aquatic organisms and it has been shown that toxic concentrations cannot be reached in the aquatic environment, presumably due to the limited water solubility. Furthermore, as the substance is handled exclusively under strictly controlled conditions, it is not released to the environment and no PECs can be calculated which could then be compared to the PNECs. In consequence, no PNECs can be derived for the aquatic and terrestrial environment.

Conclusion on classification

L(E)L 50 acute-values for fish, daphnia and algae are all >100 mg/L (based on nominal concentration of test material, testing of pure submission substance technically not possible). As there are no further grounds for concern, no environmental classification is required for the submission substance.