Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.002 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.019 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:
0.58 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.058 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:
0.115 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Ecotoxicity studies with TEA-Esterquats did not show acute toxicity values < 1 mg/L.

Short-term toxicity to aquatic organisms

Fish: LC50(96 h) = 1.91 mg/L

Crustacea: EC50(24 h) = 2.23 mg/L 

Algae or aquatic plants: ErC50= 2.14 mg/L

 

Long-term toxicity to aquatic organisms

ErC10 (72 h) = 1.48 mg/L resulting from a Weight of Evidence approach from 5 valid and comparable studies (OECD 201)

 

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. Long-term exposure of aquatic organisms is therefore unlikely.

Bioaccumulation:

BCF = 13 l/kg ww (measured data similar substance); Log Pow =logKow= 4.725 (calculated, weighted mean of mono-, di- and tri-esterquats, unique chain-length C18) Bioaccumulation in organisms is considered to be low. Therefore, secondary poisoning through the food chain is of no concern forTEA-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. The low bioavailability of the substance (due to rapid and strong sorption to negatively charged surfaces in soil) in combination with the rapid (bio)degradation of the bioavailable fraction (mainly due to the hydrolysis of the ester bond), make high bioconcentration factors for the substance even more improbable.

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.

The registration substance does not need to be classified with regard to environmental effects; an environmental exposure assessment is not required.

Conclusion on classification

In conclusion, ecotoxicity studies with TEA-Esterquats did not show acute toxicity values < 1 mg/L.

Further, the substance proved to be readily biodegradable in a number of biodegradation tests.

Measured data for bioaccumulatino show BCF < 500 (measured value: 13 l/kg ww)

According to Directive 67/548/EEC,TEA-Esterquats need not to be classified as “dangerous to the environment” and therefore labelling is not applicable.

According to GHS Regulation EC No 1272/2008, TEA-Esterquats need not to be classified as “hazardous to the aquatic environment” (acute/short-term, long-term) and need not to be classified as “hazardous to the ozone layer”. Therefore labelling is not applicable.