Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.006 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
1 mg/L

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
21.8 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:
1 mg/kg soil dw
Assessment factor:
1 000
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
222 mg/kg food
Assessment factor:
90

Additional information

The PNEC for the aquatic environment are derived from the lowest long-term results (EC10 or NOECs) observed in the available three species (fish, Daphnia and algae) representing three trophic levels by applying the appropriate assessment factors.

Four long-term toxicity tests were available on this substance, which reported EC10 or NOECs based on the nominal concentrations and on mean measured concentrations. As there were no adverse effects seen in any study, it was decided that the nominal values should be used. In all four acute studies the lowest NOEC value was 0.06 mg/L, therefore this figure was used to calculate the PNECs.

 

PNEC STP was derived from the available study on microbial respiration inhibition, giving a NOEC of 1000 mg/L, by applying an assessment factor of 10. The PNEC secondary poisoning was derived from the available information on repeated dose toxicity of 1000 g/kg bw/day by applying an assessment factor of 90.

 

For sediment PNECs, wet weight PNECs were calculated using equilibrium partitioning as described in Guidance R.10 and R.16, conversion to dry weight was performed using a factor of 4.6.

 

PNEC for soil is derived from the available study on short-term toxicity test(s) of earthworm, giving a LC50 > 1000 mg/kg dw soil by applying an assessment factor of 1000.

Conclusion on classification

Environmental classification and labelling of a substance is generally based on the data from short-term aquatic toxicity results and adequate chronic toxicity data for all three trophic levels.

The lowest short-term L(E)C50 was greater than nominal concentration of 100 mg/L from all three acute toxicity studies.

Adequate chronic toxicity data available for all three trophic levels with NOEC/EC10 all equal to or greater than the limit nominal concentration or highest nominal concentration.

Based on the above data, the test substance is not classified as hazardous to the aquatic environment according to the CLP Regulation1272/2008/EC.