Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.001 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.003 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 mg/L
Assessment factor:
500
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.003 mg/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.044 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:
0.087 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

PNEC freshwater sediment:


K_(susp-water) = 112


RHO_(susp) = 1150


Conversion factor (wwt -> dwt): 4.6


 


PNEC_freshwater sediment


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


= (112/1150) * 9.8E-04 * 1000


= 0.095 mg/kg wwt


= 0.439 mg/kg dwt


 


 


PNEC marine water sediment:


K_(susp-water) = 112


RHO_(susp) = 1150


Conversion factor (wwt -> dwt): 4.6


 


PNEC_marine water sediment


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


= (112/1150) * 9.8E-05 * 1000


= 0.0095 mg/kg wwt


= 0.0439 mg/kg dwt


 


 


PNEC soil:


K_(soil-water) = 133


RHO_(soil) = 1700


Conversion factor (wwt -> dwt): 1.13


 


PNEC_soil


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


= (133/1700) * 9.8E-04 * 1000


= 0.0767 mg/kg wwt


= 0.087 mg/kg dwt

Conclusion on classification

Acute toxicity:


Fish is the most sensitive specie for the acute toxic effects of the test item with an acute EC50 of 0.33 mg/L. Based on the this data, the substance has to be classified with regard to short-term (acute) environmental toxicity with aquatic acute cat. 1 (H400: Very toxic to aquatic life, M = 1) according to Regulation (EC) No 1272/2008 (CLP/GHS), as amended for the eighteenth time in Regulation (EU) 2022/692.


 


Chronic toxicity:


Classification of the test item is based on long-term toxicity data.


Aquatic invertebrates are the most sensitive species to long-term toxic effects of the test item with a chronic NOEC of 0.049 mg/L. Algae toxicity (72 h) confirms this value with an EC10 value of 0.06 mg/L. As the test item is ready biodegradable, the substance is classified as long-term (chronic) aquatic cat. 2 (H411: Toxic to aquatic life with long lasting effects) according to Regulation (EC) No 1272/2008 (CLP/GHS), as amended for the eighteenth time in Regulation (EU) 2022/692.