Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.012 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.122 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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
10 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.006 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:
0.006 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: 0.066 mg/kg dw

K_(susp-water) = 1.36

RHO_(susp) = 1150

Conversion factor (wwt -> dwt): 4.6

PNEC_freshwater sediment

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

= (1.36/1150) * 0.0122 * 1000

= 0.0144 mg/kg wwt

= 0.066 mg/kg dw

 

PNEC marinewater sediment: 0.0064 mg/kg dw

K_(susp-water) = 1.36

RHO_(susp) = 1150

Conversion factor (wwt -> dwt): 4.6

PNEC_marinewater sediment

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

= (1.36/1150) * 0.00122 * 1000

= 0.0014 mg/kg wwt

= 0.0064 mg/kg dw

 

PNECsoil: 0.0056 mg/kg dw

K_(soil-water) = 0.692

RHO_(soil) = 1700

Conversion factor (wwt -> dwt): 1.13

PNEC_soil

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

= (0.692/1700) * 0.0122 * 1000

= 0.0049 mg/kg wwt

= 0.0056 mg/kg dw

Conclusion on classification

Classification related key information

- Biodegradation: not readily biodegradable: 8.8% degradation (O2 consumption) after 28 days (OECD TG 301D)

- Bioaccumulation: log Pow = 0.26 at 25 °C (calculated)

 

Aquatic acute toxicity

- Aquatic invertebrates: EC50 (48 h) > 100 mg/L (nominal, Daphnia magna, OECD 202)

- Algae: ErC50 (72 h) = 34.9 mg/L (measured geometric mean, Raphidocelis subcapitata, OECD 201)

- Fish: LC50 (96 h) > 100 mg/L (nominal, Danio rerio, OECD 203)

 

Aquatic chronic toxicity

- Algae: ErC10 (72 h) = 12.2 mg/L (measured geometric mean, Raphidocelis subcapitata, OECD 201)

 

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 not found to be readily biodegradable under the test conditions. The most sensitive test for the aquatic compartment was the toxicity test to algae (Raphidocelis subcapitata). The test revealed a 72-hour ErC50 and ErC10 (growth rate) of 34.9 mg/L and 12.2 mg/L, respectively. The log Pow was determined to be 0.26. Based on these results, the substance is not classified for aquatic short-term (acute) toxicity, but classified for aquatic long-term (chronic) toxicity Category 3 (H412, Harmful to aquatic life with long lasting effects) according to Regulation (EC) No 1272/2008 (CLP), as amended for the fourteenth time in Regulation (EU) 2020/217.