Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
79 µg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.79 mg/L

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:
2.84 mg/kg sediment dw
Assessment factor:
1
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.284 mg/kg sediment dw
Assessment factor:
1
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:
0.11 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
66.67 mg/kg food
Assessment factor:
300

Additional information

PNEC aqua (freshwater):

The PNEC for the aquatic environment are derived from the lowest effect level observed in the available acute aquatic toxicity tests by applying the relevant assessment factors to the lowest L(E)C50 in accordance with ECHA Guidance R.10.

PNEC aqua (marine water):

The PNEC for the aquatic environment are derived from the lowest effect level observed in the available acute aquatic toxicity tests by applying the relevant assessment factors to the lowest L(E)C50 in accordance with ECHA Guidance R.10.

PNEC aqua (intermittent releases):

The PNEC for the aquatic environment are derived from the lowest effect level observed in the available acute aquatic toxicity tests by applying the relevant assessment factors to the lowest L(E)C50 in accordance with ECHA Guidance R.10.

PNEC STP:

PNECSTP can be calculated via biodegradation studies or ASRI studies where the concentration where no toxicity to microorganisms was observed (can be considered NOEC). An assessment factor of 10 should be used when evaluation PNECSTP in this way.

PNEC sediment (freshwater):

Wet weight PNECs were calculated with using equilibrium partitioning as described in Guidance R.10 & R.16, conversion to dry weight was performed with factor of 4.6.

e.g.

1: Kpsusp= Weight fraction organic carbon in suspended matter (0.1) x partition coefficient organic carbon-water(Koc)

2: Ksusp-water= fraction water in suspended matter(0.9)+(fraction solids in suspended matter (0.1) x (Kpsoil / 1000) x density of solid phase(2500))

3: PNECwet.sediment = (Ksusp-water/bulk density of wet suspended matter(1150)) x PNECwater x 1000

4: PNECsediment = PNECwet.sediment x 4.6

PNEC sediment (marine water):

Wet weight PNECs were calculated with using equilibrium partitioning as described in Guidance R.10 & R.16, conversion to dry weight was performed with factor of 4.6.

e.g.

1: Kpsusp= Weight fraction organic carbon in suspended matter (0.1) x partition coefficient organic carbon-water(Koc)

2: Ksusp-water= fraction water in suspended matter(0.9)+(fraction solids in suspended matter (0.1) x (Kpsoil / 1000) x density of solid phase(2500))

3: PNECwet.sediment = (Ksusp-water/bulk density of wet suspended matter(1150)) x PNECwater x 1000

4: PNECsediment = PNECwet.sediment x 4.6

PNEC soil:

Wet weight PNECs were calculated with using equilibrium partitioning as described in Guidance R.10 & R.16, conversion to dry weight was performed with factor of 1.13.

e.g.

1: Henry's Law Constant = (Vapour Pressure x Molecular Weight)/Water Solubility

2: Kair-water = Henry's Law Constant/(Ideal Gas Constant(8.314) x air-water interface temperature (285K))

3: Kpsoil = Weight fraction organic carbon in soil(0.02) x partition coefficient organic carbon-water(Koc)

4: Ksoil-water= (fraction air in soil (0.2) x Kair-water) + fraction water in soil (0.2) + (fraction solids in soil (0.6) x (Kpsoil / 1000) x density of solid phase (2500))

5: PNECwetsoil = (Ksoil-water/bulk density of wet soil(1700)) x PNECwater x 1000

6: PNECsoil = PNECwetsoil x 1.13

Conclusion on classification

The substance is not classified and is not expected to cause any concern to the environment. The substance has been classed as readily biodegradable. Three short term aquatic toxicity studies were investigated and the results are as follows:

The results of the three short term aquatic tox studies were as follows:

Fish LC50 = > 1000 mg/L Fish NOEC = 1000 mg/L

Daphnia EC50 = > 1000 mg/L Daphnia NOEC = 1000 mg/L

Algae EC50 = 790 mg/L Algae NOEC = 100 mg/L

An ASRI study was also conducted and gave the following results:

ASRI LC50 = 1000 mg/L ASRI - NOEC = 1000 mg/L

The above results confirm that the test material is not classified as hazardous to the environment. Further information in section 13 (please see the assessment report that includes a generic waiver and provides further information as to why our substance will prevent is not harmful to the environment).