Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.033 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:
0.067 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

PNECs were derived based on test data following standard guidelines. All data are considered to be reliable and relevant for the endpoint concerned.

Short-term aquatic data in freshwater are available for three trophic levels for the test item. The most sensitive endpoint was determined to be Daphnia, with a 48 -hour EC50 of 0.2 mg/L (Brixham 2012). This endpoint was used to derive the PNECs for freshwater, marine water and intermittent releases by assessment factor method, and freshwater sediment, marine sediment and soil by equilibrium partitioning approach.

For derivation of the PNEC for STP, the NOEC of 60 mg/L was taken from the 3-hour respiration inhibition test (Brixham 2012). A PNEC of 6 mg/L is derived by applying an assessment factor of 10.

The test item it is considered to be not a precursor to ozone formation and is not expected to be a significant contribution to global warming. The test item is not an ozone depleting substance as defined by the Montreal Protocol and does not contain chemical constituents that would lead to acidification.

No hazard is expected from secondary poisoning.

Conclusion on classification

Acute aquatic data are available for three trophic levels for the test item. Chronic toxicity data are only available for algae. The most sensitive endpoint was determined to be Daphnia, with a 48 -hour ErC50 of 0.2 mg/L (Brixham 2012). The test item is highly soluble in water with solubility of 143 g/L and the acute toxicity result for the most sensitive trophic level is ≤ 1 mg/L, therefore the test item is classified as hazardous to the aquatic environment with Category Acute 1 and an M-factor of 1 is applied. Since chronic data is available only for algae for the test item, classification with both the acute and chronic data must be considered and the substance classified according to the most stringent outcome. Therefore, based on acute toxicity data ≤ 1 mg/L, the test item is classified as Category Chronic 1 and an M-factor of 1 is applied.