Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.054 µg/L
Assessment factor:
100
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.004 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:
0.009 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

PNEC sediment

 

Ksusp-water: 20.4 (according to EUSES)

RHOsusp: 1150 kg/m3(according to the CSA Guidance document equation R10-2)

PNECsediment-freshwater= (Ksusp-water/RHOsusp) * PNECfreshwater*1000

PNECsediment-freshwater= (20.4/1150) * 0.00054 mg/L * 1000

PNECsediment-freshwater= 0.00958 mg/kg wwt

PNECsediment-freshwater= 0.0441 mg/kg dwt (factor 4.6)

 

PNECsediment-marine water= (Ksusp-water/RHOsusp) * PNECmarine-water*1000

PNECsediment-marine water= (20.4/1150) * 0.000054 mg/L * 1000

PNECsediment-marine water= 0.000958 mg/kg wwt. 

PNECsediment-marine water= 0.00441 mg/kg dwt (factor 4.6)

PNEC soil 

Ksoil-water: 23.6 (according to EUSES v. 2.1.2)

RHOsoil: 1700 kg/m3(according to the CSA Guidance document, chapter R.10, May 2008, equation R10-5)

PNECsoil= (Ksoil-water/RHOsoil) * PNECfreshwater*1000

PNECsoil= (23.6/1700) * 0.00054 mg/L * 1000

PNECsoil= 0.0075 mg/kg wwt

PNECsoil= 0.0085 mg/kg soil dwt (factor 1.13)

Conclusion on classification

Fish (Channel catfish): LC50 (96 hours): 0.632 mg/L

Daphnia: Chironomus tentans: LC50 (96 hours): 0.534 mg/L

Algae (Nitzschia sp.): EC50 (96 h): 1.2 mg/L

Microorganisms: EC50 value (3h): 48.6 mg/L (95% confidence limits: 42.2–56.3 mg/L). NOEC: 10.24 mg/L.

The test item is regarded as not biodegradable.

Classification according to CLP

Based on the data above, the substance has to be classified for short-term (acute) and long-term (chronic) aquatic toxicity according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776. For short-term (acute) aquatic toxicity the test item is classified as Cat 1 (H400: Very toxic to aquatic life, M-factor 1), for long-term (chronic) aquatic toxicity as Cat 1 (H410: Very toxic to aquatic life with long lasting effects, M-factor 1).