Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
6.4 µg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
1 000 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
1.12 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:
2 mg/kg soil dw
Assessment factor:
50
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Studies of this substance are available for evaluating biodegradation, microbial metabolism, and toxicity to aquatic vertebrate and invertebrate species.

 

This substance is not readily biodegradable when tested in accordance with OECD Guideline 301B. The test shows that the substance attained 16% biodegradation after 28 days.

 

This substance caused a significant adverse effect on the oxygen consumption of the microbes associated with the activated sludge (OECD Guideline 209). The EC50for inhibition of metabolism, as represented by respiration, was greater than 10,000 ppm. The calculated no adverse effect concentration (NOAEC) is equal 1000 ppm.

 

The acute aquatic toxicity of the test material was evaluated using rainbow trout and was conducted in accordance with OECD 203 and U.S. EPA 797 Guidelines. The96 hour LC50 and the NOEC were determined to be 44.35 mg/L and 33.02 mg/L, respectively. No sublethal effects were observed during the 72 hour testing period in all treatments and controls. The sublethal effect of lethargy was observed in one organism in the 0.11 mg/L test concentration at the 96 hour exposure period.

 

In an acute toxicity of this substance with daphnia magna (OECD Guideline 202) the 48-Hour EL*50 was 11 mg/l loading rate WAF. The No Observed Effect Loading rate was 1.8 mg/l loading rate WAF. 

 

In an acute study with freshwater algae that was conducted in accordance with OECD Guideline 201 and US EPA (TSC) 797.1050 the 96 hour EC50for this substance was 120 mg/L based on growth rate and 96 hour NOEC was 27 mg/L when calculated using cells/ml and 120 mg/l when determined using the average specific growth rate. The NOEC was 3.3 mg/L when determined using either the number of cells/ml or the average specific growth rate.

Chronic toxicity was evaluated in Daphnia (OECD guidance 211). the 21d EL50 (immobilisation) was > 10mg/L; the 21d EL50 (reproduction) was 7.8 mg/L; the 21d NOELR based on immobilisation and reproduction was 3.2 mg/L

Based on the available environmental fate and ecotoxicological data for daphnids, fish and algae, this substance does not needs to be classified as according to the EU CLP (Regulation (EC) No. 1272/2008).