Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.003 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.034 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.034 mg/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.002 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:
0.002 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) = 1.53

RHO_(susp) = 1150

Conversion factor (wwt -> dwt): 4.6

PNEC_freshwater sediment

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

= (1.53 / 1150) * 0.0034 * 1000

= 0.0045 mg/kg wwt

= 0.0208 mg/kg dw

 

PNEC marine water sediment:

K_(susp-water) = 1.53

RHO_(susp) = 1150

Conversion factor (wwt -> dwt): 4.6

PNEC_marine water sediment

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

= (1.53 / 1150) * 0.00034 * 1000

= 0.00045 mg/kg wwt

= 0.00208 mg/kg dw

 

PNEC soil:

K_(soil-water) = 0.962

RHO_(soil) = 1700

Conversion factor (wwt -> dwt): 1.13

PNEC_soil

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

= (0.962 / 1700) * 0.0034 * 1000

= 0.0019 mg/kg wwt

= 0.0022 mg/kg dw

Conclusion on classification

Aquatic acute toxicity

96 h, LC50 (Danio rerio): >100 mg/L (nominal concentration)

48 h, EC50 (Daphnia magna): 19.7 mg/L (nominal concentration)

72 h, ErC50 (Pseudokirchneriella subcapitata): 3.4 mg/L (measured geometric mean concentration)

 

Aquatic chronic toxicity

72 h, ErC10 (Pseudokirchneriella subcapitata): 2.5 mg/L (measured geometric mean concentration)

 

Biodegradation: not readily biodegradable: 12.2 % after 28 days (%degradation O2 consumption, OECD 301 D)

Partition coefficient: log Kow = 0.74 at 20 °C

 

Classification according to CLP

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. The test substance was found not to be readily biodegradable under the test conditions. The most sensitive test for the aquatic compartment was the toxicity test to algae. This study revealed a 72h-EC50 of 3.4 mg/L and the 72h-EC10 of a toxicity to alga and cyanobacteria test with the test substance was determined to be 2.5 mg/L. Based on these results, the substance is not classified with regard to short-term (acute) aquatic toxicity and is classified as long-term (chronic) aquatic toxicity Category 2 (H411) according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Commission Regulation (EU) 2017/776.