Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2 µg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
37 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.2 µg/L
Assessment factor:
500
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
3.7 µg/L

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
2.71 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
1.02 µg/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:
0.89 µg/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 the source substance Partially unsaturated IQAC, DMS quaternised show chronic toxicity values < 1 mg/L for aquatic invertebrates and algae. These values are considered to be relevant also for the target substance C16-18FA-TEPA compound.

 

Short-term toxicity to aquatic organisms

Fish: LC50(96 h) = 9.84 - 10.24 mg/L for Oncorhynchus mykiss (OECD 203)

Crustacea: EC50(48h) = 3.7 mg/L for Daphnia magna (OECD 202)

Algae or aquatic plants: ErC50(72 h) = 4.8 mg/L for Pseudokirchneriella subcapitata (OECD 201)

 

Long-term toxicity to aquatic organisms

35 d NOEC > 100μg/L for Desmodesmus subspicatus

63 d NOEC > 100μg/L for Daphnia magna

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

No toxicity data for soil and sediment dwelling organisms are available. Thus, the PNEC for freshwater and marine sediment as well as for soil has been calculated with the equilibrium partitioning method using EUSES 2.1.

The following data have been taken into account for calculation:

 

Molecular weight

500 g/mol

Melting point

43.9°C

Boiling point

390°C

Vapour pressure

0.001 Pa at 20°C

Water solubility

0.15 mg/L at 20°C

Log Kow

0.3

PNEC Aqua(freshwater)

2 µg/L

PNEC Aqua(marine water)

0.2 µg/L

 

  

Biodegradation in water: not readily biodegradable

 

Bioaccumulation is not expected based on a log Low <0.3, therefore, secondary poisoning through the food chain is of no concern.

 

Ozone layer: Due to the ionic structure and a corresponding negligible vapour pressure of the substance a relevant concentration of the substance in the atmospheric compartment is not expected. 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.

 

C16-18FA-TEPA compound is classified with regard to environmental effects (Aquatic Chronic 2, H411).

Conclusion on classification

Results from acute tests with fish, Daphnia and algae are available. Long-term studies are available for Daphnia and Algae. The lowest short-term aquatic toxicity test result is the EC50(48 h) = 3.7 mg/L for Daphnia magna (OECD 202) (Acute toxicity test). This value is well above the threshold value for classification of 1 mg/L.

The long-term 63 d NOEC > 100 μg/L for Daphnia magna and the long-term 35 d NOEC > 100 μg/L for Desmodesmus subspicatus are below 1 mg/L. The substance is not readily biodegradable.

 

According to GHS Regulation EC No. 1272/2008 C16-18FA-TEPA compound is classified as hazardous to the environment with Aquatic Chronic 2, H411.

According to Directive 67/548/EEC C16-18FA-TEPA compound is classified as hazardous to the environment R51/53.