Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 closely related source substances partially unsaturated TEA-Esterquat and fully saturated TEA-Esterquat 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

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

 

PNEC aqua (freshwater), PNEC aqua (marine), PNEC aqua (intermittent release)

Three acute studies with freshwater fish, invertebrates and algae are available, but no long-term or reproduction study, nor studies with marine organisms. Therefore, in accordance with the Guidance on Information requirements and chemical safety assessment, R.10, an assessment factor of 1000 was applied and the PNEC aqua (freshwater) was derived from the 96 h LC50 value of 1.91 mg/L, determined with Oncorhynchus mykiss, the most sensitive of the organisms tested. This results in a PNECaqua (freshwater) of 0.00191 mg/L.

 

An assessment factor of 10000 was applied and the PNEC aqua (marine) was derived from the 96 h LC50 value of 1.91 mg/L, determined with Oncorhynchus mykiss. This results in a PNECaqua (marine) of 0.000191 mg/L.

 

An assessment factor of 100 was applied to the lowest L(E)C50, which was the 96 h LC50 = 1.91 mg/L, determined with Oncorhynchus mykiss. Thus, the PNECaqua(Intermittent release) was calculated to be 0.0191 mg/L L.

 

PNEC STP

The PNEC STP was based on the 30 min EC10 of 29.6 mg/L obtained in a respiration inhibition test according toDIN 38412 part 27. Based on the available data, an assessment factor of 10 was applied in accordance with the Guidance in Information requirements and chemical safety assessment, R.10, to calculate the PNEC STP = 2.96 mg/L.

 

PNEC air

The substance has no Ozone depletion potential (doesn't contain Carbon-Halogen bonds) and has a low vapour pressure of 4.4E-4 Pa at 20°C (due to the ionic structure and high molecular weight). Based on this no risk for air breathing animals and humans is expected.

 

PNECoral (secondary poisoning)

Bioaccumulation potential has been estimated to be low. There is no concern for secondary poisoning and therefore no PNECoral (secondary poisoning) was derived.

 

PNEC sediment(freshwater), PNEC sediment (marine waters), PNEC soil

No toxicity tests with sediment dwelling or terrestrial organisms are available. Thus, in accordance with the Guidance on information requirements and chemical safety assessment, Chapter R.10: Characterisation of dose [concentration]-response for environment, 2008, the PNEC for freshwater and marine water sediment as well as the PNEC soil have been calculated with the equilibrium partitioning method using EUSES 2.1.

 

The following data have been taken into account for calculation: 

Molecular weight

 

726 g/mol (weighted mean)

Melting point

 

85°C

Vapour pressure

 

4.4E-4 Pa at 20°C

 

Water solubility

 

3.39 mg/L (pH 7.1 at 20 °C)

Log Kow

 

4.725 at 25 °C

PNEC Aqua(freshwater)

 

0.00191 mg/L

PNEC Aqua(marine water)

 

0.000191 mg/L

 

The calculation resulted in a PNEC sediment(freshwater) of 0.58 mg/kg sediment dw, a PNEC sediment (marine waters) of 0.058 mg/kg sediment dw and a PNEC soil of 0.115 mg/kg soil dw.

 

Biodegradation:

Biodegradation in water: Readily biodegradable

The substance is readily biodegradable. The ready biodegradability of the closely related source substance partially unsaturated TEA-Esterquat 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 (measured data similar substance); log Kow= 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 for target substance C18 and C18 unsatd. TEA-Esterquat. The substance is regarded as readily biodegradable and hydrolysable, which will result in lower environmental concentrations for the substance. The substance is metabolised in higher organisms by de-esterification 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:

Due 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

In conclusion, ecotoxicity studies with the closely related source substances partially unsaturated TEA-Esterquat and fully saturated TEA-Esterquat did not show acute toxicity values < 1 mg/L.

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

Measured data for bioaccumulation on the structurally related substance DODMAC show a BCF < 500 (measured value: 13 L/kg).

According to GHS Regulation EC No 1272/2008, C18 and C18 unsatd. TEA-Esterquat does not need 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.