Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.001 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.08 mg/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.058 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:
0.11 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) = 18.2

RHO_(susp) = 1150

Conversion factor (wwt -> dwt): 4.6

PNEC_freshwater sediment

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

= (18.2/1150)*0.008*1000

= 0.13 mg/kg wwt

= 0.58 mg/kg dw

PNEC marine water sediment:

K_(susp-water) = 18.2

RHO_(susp) = 1150

Conversion factor (wwt -> dwt): 4.6

PNEC_marine water sediment

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

= (18.2/1150)* 0.0008 * 1000

= 0.013 mg/kg wwt

= 0.058 mg/kg dw

PNEC soil:

K_(soil-water) = 21

RHO_(soil) = 1700

Conversion factor (wwt -> dwt): 1.13

PNEC_soil

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

= (21/1700)*0.008*1000

= 0.098 mg/kg wwt

= 0.11 mg/kg dw

Conclusion on classification

Aquatic acute toxicity

96 h, LC50 ( Oncorhynchus mykiss): 10 - 13 mg/L (nominal concentration)

48 h, EC50 (Daphnia magna): 22 mg/L (nominal concentration)

72 h, ErC50 (Pseudokirchneriella subcapitata): 8.33 mg/L (geometric mean measured concentration)

 

Aquatic chronic toxicity

72 h, ErC10 (Pseudokirchneriella subcapitata): 4.86 mg/L (geometric mean measured concentration)

 

Biodegradation: readily biodegradable: 81 % after 21 days (% degradation O2 consumption, OECD 301 D)

Partition coefficient: log Kow = 3.5  at 35 °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 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 8.33 mg/L and the 72h-EC10 of a toxicity to alga and cyanobacteria test with the test substance was determined to be 4.86 mg/L. Based on these results, the substance is neither classified as aquatic acute toxicity nor classified as aquatic chronic according to Regulation (EC) No 1272/2008 (CLP) as amended for the eighth time in Commission Regulation (EU) 2016/918.