Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
48.917 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:
97.832 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Environmental Classification related key information for FAT93450:

The substance is hydrolytically stable, as it contains no chemical groups liable to hydrolysis. Furthermore, a low potential for bioaccumulation in aquatic and terrestrial organisms is expected, based on the measured octanol/water partition coefficients (log Kow 3.38).

 

Biodegradation in water: not biodegradable (OECD 302C)

Bioaccumulation: low potential to bioaccumulate; log Kow 3.38 (OECD 117)

Water solubility: 1.29 mg/L at 20 ºC (OECD 105)

The summary of acute aquatic toxicity data for substance:

For fish: 96-h LC50 to Brachydanio rerio (Danio rerio)= 650 mg ai /L

For invertebrates: 48-h EC50 to Daphnia magna, immobilization = 96 mg ai /L

For Lemna: 7-d EC50 to Duckweed, Lemna gibba G3, growth rate = 2.97 mg ai /L (OECD 221).

For microorganism: 3h EC10 to the activated sludge, respiration inhibition= 960 mg ai /L (OECD 209).

Chronic aquatic toxicity data for substance:

For Lemna: 7-d NOEC to Duckweed, Lemna gibba G3, growth rate = 0.293 mg ai/L (OECD 221).

Based on available acute toxicity data for FAT93450, the lowest valid effect concentration for freshwater aquatic organisms is 2.97 mg/L (EC50 value for the Lemna). Based on the available acute data, the substance should not be classified for acute aquatic toxicity, but should be classified as Chronic Cat 2, H411 according to CLP.