Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.007 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.073 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:
1 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.005 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:
0.008 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

PNEC freshwater sediment:

K_(susp-water) = 1.88

RHO_(susp) = 1150

Conversion factor (wwt -> dwt): 4.6  

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

= (1.88/1150)*0.00729 *1000

= 0.0119 mg/kg wwt

= 0.0548 mg/kg dwt  

 

PNEC marine water sediment:

K_(susp-water) = 1.88

RHO_(susp) = 1150

Conversion factor (wwt -> dwt): 4.6  

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

= (1.88/1150)*0.000729* 1000

= 0.00119 mg/kg wwt

= 0.00548 mg/kg dwt  

 

PNEC soil:

K_(soil-water) = 1.62

RHO_(soil) = 1700

Conversion factor (wwt -> dwt): 1.13  

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

= (1.62/1700)*0.00729 * 1000

= 0.0069 mg/kg wwt

= 0.0079 mg/kg dwt

 

 

Conclusion on classification

Acute aquatic toxicity

Daphnia were the most sensitive species in aquatic toxicity tests resulting in a 48-hour EC50 of 7.29 mg/L. In addition algae and fish EC50 values were 162.69 and >41.8 mg/L, respectively. The test substance therefore is toxic to aquatic organisms.

Chronic aquatic toxicity

The test substance was tested in an aquatic toxicity test with algae. The 72-hour EC50 for growth rate was 162.69 mg/L and the 72-hour EC10 was 69.07 mg/L. The test substance was not ready biodegradable. Classification was based on the most sensitive aquatic species in acute tests, which was the daphnia (EC50 of 7.29 mg/L in a 48-hour study).

 

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is classified with the risk phrases R51/53 (Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment) under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.

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. As a result the substance is not considered to be classified for acute aquatic toxicity. But, as the test substance is not readily biodegradable, it is considered to be classified as environmental chronic toxic cat. 2 (H411:Toxic to aquatic life with long lasting effects) under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation EC 605/2014.