Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.001 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.006 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:
2.96 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.001 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:
0.002 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Short-term toxicity to aquatic organisms

Short-term toxicity to fish: LC50(96 h) = 1.91 mg/L

Short-term toxicity toi aquatic invertebrates: EC50(48 h) = 0.616 mg/L 

Toxicity aquatic algae (72 h): ErC50 = 2.14 mg/L

Long-term toxicity to aquatic organisms

Toxicity to aquatic algae (72 h): ErC50: 2.14 mg/L; ErC10: 0.96 mg/L and NOEC: 0.65 mg/L  

Biodegradation:

Biodegradation in water: Readily biodegradable

The substance is readily biodegradable. The ready biodegradability of the substance is proved in a number of tests conducted under different conditions (aerobic, anaerobic). Toxicity towards aquatic micro-organisms is expected to be of no concern for sewage treatment plants.

 

Bioaccumulation:

The experimentally log Kow is determined to be 1.80, whereas the modelled log Kow is 3.82. Bioaccumulation in organisms is considered to be low. Therefore, secondary poisoning through the food chain is of no concern for TEA-Esterquats. TEA-Esterquats are readily biodegradable/hydrolysable, which will result in lower environmental concentrations for the registration substance. TEA-Esterquats are metabolised in higher organisms. The substances are de-esterified and further degraded via the fatty-acid metabolic pathway

 

The exposure and uptake of sediment and soil organisms is unlikely as the substance is readily biodegradable.

 

Ozone layer: According to a low vapour pressure of the ionic substance, the predicted environmental fate is not the atmosphere. The registration substance is not expected to reach the atmospheric stratosphere and therefore is not expected to present a danger to the structure and/or the functioning of the stratospheric ozone layer.

Conclusion on classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. The test substance was found to be readily biodegradable under the test conditions. The most sensitive test for the aquatic compartment was the short-term toxicity to aquatic invertebrates. This study revealed a 48h-EC50 of 0.616 mg/L. The 72h-NOEC of a toxicity to alga and cyanobacteria test with a surrogate test substance was determined to be 0.65 mg/L, the 72h-EC50 was determined to be 2.14 mg/L and the 72h-EC10 was determined to be 0.96 mg/L. Based on these results, the substance is classified as aquatic acute category 1 and as aquatic chronic category 3 according to table 4.1.0 of Annex I of Regulation (EC) No 1272/2008. In addition the substance has a Hazard statement H410: Very toxic to aquatic life and H412: Harmful to aquatic life with long lasting effects, according to Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/ 776.