Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
1.27 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:
0.415 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The PNEC derivation was as follows justified:

PNEC freshwater sediment:

K_(susp-water) = 708

RHO_(susp) = 1150

Conversion factor (wwt -> dwt): 4.6

PNEC_freshwater sediment

= (K_(susp-water)/ RHO_(susp))*PNEC_water * 1000

= (708/1150)*4.4*1000

= 2.7 mg/kg wwt

= 12.5 mg/kg dw

 

PNEC marine water sediment:

K_(susp-water) = 708

RHO_(susp) = 1150

Conversion factor (wwt -> dwt): 4.6

PNEC_marine water sediment

= (K_(susp-water)/ RHO_(susp))*PNEC_marine water* 1000

= (708/1150)* 0.44 * 1000

= 0.27 mg/kg wwt

= 1.27 mg/kg dw

 

PNEC soil:

K_(soil-water) = 142

RHO_(soil) = 1700

Conversion factor (wwt -> dwt): 1.13

PNEC_soil

= (K_(soil-water)/ RHO_(soil))*PNEC_freshwater*1000

= (142/1700)*4.4*1000

= 0.367 mg/kg wwt

= 0.415 mg/kg dw

Conclusion on classification

Aquatic acute toxicity

96 h, LC50 (Danio rerio): 10.4 mg/L

48 h, EC50 (Daphnia magna): 4.4 mg/L

72 h, EC50 (Algae): 8.7 mg/L, EC10 (Algae): 0.8 mg/L

 

Biodegradation: Inherently primary biodegradable: 33 % after 28 days

Partition coefficient: log Kow = 4.44; log Koc = 3.85

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on the data above, the substance has not to be classified for short-term (acute) aquatic toxicity, but for long-term (chronic) aquatic toxicity the substance is Cat 2 (H411: Toxic to aquatic life with long lasting effects) according to Regulation (EC) No 1272/2008 (CLP), as amended for the twelfth time in Regulation (EU) No 2019/521.