Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.32 µg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.001 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.032 µg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
no hazard identified

Sediment (marine water)

Hazard assessment conclusion:
no hazard identified

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Reliable short-term toxicity studies for fish, invertebrates and algae have been conducted for the substance and are included in this dossier.  Reliable modelled data are available for the test substance for long-term chronic toxicity to the three trophic levels of aquatic organism. No study data are available for microorganisms, however a reliable (Klimisch 2) toxicity study for the analogue substance methyl trimethyl-3-[(1-oxododecyl)amino]propylammonium sulphate is available for this endpoint.

 

Elementis Specialities (2009) reports an LC50 for short term toxicity in fish of >251.3 mg/L. The model results indicate a chronic value (the geometric mean of the NOEC and LOEC) to be 0.5 mg/L for amides and fish appear to be the most sensitive organisms from the three trophic levels modelled. This value is taken for the long-term toxicity to fish endpoint.

 

Elementis Specialities (2009) reports an EC50 for short term toxicity in Daphnia magna of 136 mg/L. The ECOSAR model results indicate a chronic value to be 29 mg/L for amides. This value is taken for the long-term toxicity to invertebrates endpoint.

 

Elementis Specialities (2010) reports a 72-hr LC50 for toxicity in Pseudokirchneriella subcapitata of 0.097 mg/L and a 72-hr NOEC of 0.016 mg/L, based on growth. The ECOSAR model results indicate a chronic value to be 8 mg/L for amides. This measured laboratory toxicity test value of 0.016 mg/l is taken for the long-term toxicity to algae endpoint.

 

A reliable (Klimisch 1) toxicity study with microorganisms has been conducted on the analogue substance methyl trimethyl-3-[(1-oxododecyl)amino]propylammonium sulphate and is included in this dossier. Elementis Specialities (2012) reports a 3-hr EC50 for toxicity to microorganisms of 80 mg/L and a 3-hr NOEC of 32 mg/L. Consequently these values will be taken as the toxicity in microorganisms endpoint for the test substance trimethyl-3-[(1-oxododecyl)amino]propylammonium sulphate.

 

Modelled chronic data are available for three trophic levels and an assessment factor (AF) of 10 could be applied. However, as the modelled chronic toxicity values for algae are higher than the laboratory measured acute toxicity values for algae (0.097 mg/l) and to account for variability in interspecies sensitivity and uncertainties in the model, a larger AF of 50 is applied to the lowest NOEC in order to derive a PNEC value for the protection of aquatic organisms.The resulting PNEC is 0.00032 mg/l based on an AF of 50 applied to the measured chronic toxicity value for algae of 0.016 mg/l. The PNEC value is considered to be highly conservative given the results of the ECOSAR modelling of chronic toxicity, which are orders of magnitude higher than the measured laboratory toxicity value for algae.

Conclusion on classification

In accordance with ECHA Guidance Chapter 11, the substance is not considered to be a PBT chemical as it is readily biodegradable (not P), unlikely to bioaccumulate (log Kow of -0.73; not B) and the toxicity criterion is not fulfilled by the lowest NOEC of 0.016 mg/l for the algal study, which is above the T criterion of < 0.01 mg/L.