Registration Dossier

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Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
220 µg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.225 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:
0.45 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

The PNEC derivation was as follows justified:

PNEC freshwater sediment:

K_(susp-water) = 1210

RHO_(susp) = 1150

Conversion factor (wwt -> dwt): 4.6

PNEC_freshwater sediment

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

= (1210/1150) * 0.000465 * 1000

= 0.4892 mg/kg wwt

= 2.25 mg/kg dw

PNEC marinewater sediment:

K_(susp-water) = 1210

RHO_(susp) = 1150

Conversion factor (wwt -> dwt): 4.6

PNEC_freshwater sediment

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

= (1210/1150) * 0.0000465 * 1000

= 0.0489 mg/kg wwt

= 0.22494 mg/kg dw

PNECsoil: mg/L

K_(soil-water) = 1450

RHO_(soil) = 1700

Conversion factor (wwt -> dwt): 1.13

PNEC_soil

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

= (1450/1700) * 0.000465 * 1000

= 0.3966 mg/kg wwt

= 0.448158 mg/kg dw

Conclusion on classification

Aquatic acute toxicity

48 h, EC50 (Daphnia magna): 0.513 mg/L (based on geometric mean measured concentration)

72 h, ErC50 (growth rate) (Pseudokirchneriella subcapitata): 0.465 mg/L (based on geometric mean measured concentration)

96 h, LC50 (Danio rerio): > 0.59 mg/L (based on geometric mean measured concentration)

 

Aquatic chronic toxicity

72 h, ErC10 (growth rate): 0.264 mg/L

 

Biodegradation:

The test substance was not readily biodegradable by OECD criteria

Partition coefficient:

Log Pow = 5.74 at 21.6°C.

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 (Pseudokirchneriella subcapitata). The 72h ErC10 and the ErC50 (growth rate) of the test substance was determined to be 0.264 and 0.465 mg/L, respectively. The test substance was found to be not readily biodegradable. The substance has a log Pow of 5.74 at 21.6°C. Based on these results, the substance is classified as short term (acute) aquatic toxicity Category 1 (M-Factor = 1; H400: Very toxic to aquatic life) and classified as long term (chronic) aquatic toxicity Category 1 (M-Factor = 1; H410: Very toxic to aquatic life with long lasting effects) according to Regulation (EC) No 1272/2008 (CLP) as amended for the tenth time in Commission Regulation (EU) 2017/776. According to section 4.1.6 in ECHA Guidance on the Application of the CLP Criteria (version 5.0, July 2017), the substance is labeled with H410: Very toxic to aquatic life with long lasting effects.