Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.005 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.05 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):
0.05 mg/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.02 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:
0.035 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) = 9.64

RHO_(susp) = 1150

Conversion factor (wwt -> dwt): 4.6

PNEC_freshwater sediment

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

= (9.64/1150)*0.005*1000

= 0.042 mg/kg wwt

= 0.193 mg/kg dw

 

PNEC marine water sediment:

K_(susp-water) = 9.64

RHO_(susp) = 1150

Conversion factor (wwt -> dwt): 4.6

PNEC_marine water sediment

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

= (9.64/1150)* 0.0005 * 1000

= 0.004 mg/kg wwt

= 0.019 mg/kg dw

 

PNEC soil:

K_(soil-water) = 10.7

RHO_(soil) = 1700

Conversion factor (wwt -> dwt): 1.13

PNEC_soil

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

= (10.7/1700)*0.005*1000

= 0.031 mg/kg wwt

= 0.035 mg/kg dw

 

Conclusion on classification

Aquatic acute toxicity

96 h, LC50 (Danio rerio): 11.1 mg/L (nominal concentration)

48 h, EC50 (Daphnia magna): 16.5 mg/L (geometric mean concentration)

72 h, ErC50 (Pseudokirchneriella subcapita): 4.68 mg/L (nominal concentration)

 

Aquatic chronic toxicity

72 h, ErC10 (Pseudokirchneriella subcapita): 2.75 mg/L (nominal concentration)

 

Biodegradation: Inherently biodegradable: 38 % (% degradation O2 consumption) after 28 days (OECD 301 D)

Partition coefficient: log Kow = 2.81 for isomer 1 and 2.98 for isomer 2  at 23.6 °

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. The test substance was found to be not 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 4.68 mg/L and the 72h-EC10 of a toxicity to alga and cyanobacteria test with the test substance was determined to be 2.75 mg/L. Based on these results, the substance is not classified as aquatic acute toxicity and based on these results the substance is classified as aquatic chronic category 3 according to table 4.1.0 of Annex I of Regulation (EC) No 1272/2008 and as H412: Harmful to aquatic life with long lasting effects, according to Regulation (EC) No 1272/2008 (CLP) as amended for the eighth time in Commision Regulation (EU) 2016/1688.