Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.008 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.083 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
PNEC marine water (intermittent releases):
0.083 mg/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.007 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:
0.01 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:

K_(susp-water) = 2.23

RHO_(susp) = 1150

Conversion factor (wwt -> dwt): 4.6

PNEC_freshwater sediment

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

= (2.23 / 1150) * 0.0083 * 1000

= 0.016 mg/kg wwt

= 0.074 mg/kg dw

PNEC marine water sediment:

K_(susp-water) = 2.23

RHO_(susp) = 1150

Conversion factor (wwt -> dwt): 4.6

PNEC_marine water sediment

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

= (2.23 / 1150) * 0.00083 * 1000

= 0.0016 mg/kg wwt

= 0.0074 mg/kg dw

PNEC soil:

K_(soil-water) = 1.8

RHO_(soil) = 1700

Conversion factor (wwt -> dwt): 1.13

PNEC_soil

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

= (1.8 / 1700) * 0.0083 * 1000

= 0.0088 mg/kg wwt

= 0.0099 mg/kg dw

Conclusion on classification

Acute aquatic toxicity:

Daphnia is the most sensitive aquatic species with an EC50 of 8.3 mg/L. In conclusion, the substance has not to be classified with regard to acute toxicity according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EC) No. 2017/776.

Chronic aquatic toxicity:

Daphnia is the most sensitive aquatic species with short-term EC50 of 8.3 mg/L. For classification and labelling the Algae 72-h ErC10-value based on growth rate inhibition as determined to be 1.8 mg/L, has also to be taken into account. Under the test conditions the percentage of ready biodegradation of the test substance reached a mean of 24.8 % after 28 days based on its ThODNH4. The test item can be considered to be not ready biodegradable. Thus, based on the available data, the substance has to be classified as environmental chronic toxic cat. 2 (H411: Toxic to aquatic life with long lasting effects.) according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EC) No. 2017/776.