Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.406 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
4.06 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
40.6 ng/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.406 µg/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
50.1 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:
100 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The aquatic toxicity of the test item was assessed by read-across from a structural analogue (DV6850), which was tested in short-term toxicity tests to fish, daphnia and algae. All tests had the highest reliability rating (Klimisch code 1). Fish was the most sensitive organism with an LC50 of 0.406 mg/L, followed by daphnia with an EC50 of 33.6 mg/L. For algae, ErC50 and NOEC of 85.4 mg/L and 42.9 mg/L were reported, respectively.

The results indicate that fish are the most sensitive organism to the target substance, indicating that it is very toxic.

Furthermore, the effect of DV6850 on the respiration rate of activated sludge was assessed in a valid GLP study (Klimisch 1). DV6850 was reported to have had no effect on the respiration rate of activated sludge at any of the concentrations employed in the test. The NOEC was reported as 100 mg/L, the highest concentration tested and the EC50 was reported as > 100 mg/L.

A read-across justification document has been prepared in compliance with the RAAF guidance from ECHA, and is attached to Section 13.

Conclusion on classification

Boundary composition.001 (Composition of C18:1 amidopropyl betaine containing≥0.1% and < 10% C18:1 aminopropyl amide)

The target substance (TS) is classified as "hazardous to the aquatic environment", Category Acute 1, Chronic 2, according to Commission Regulation (EU) No 286/2011 of 10 March 2011 (second amendment of CLP regulation), as the 96 hour LC50 for fish is lower than 1 mg/L and the amide impurity (N-[3-(dimethylamino)propyl]aleamide, CAS#109-28-4, EC#203-661-5) is classified as Category Acute 1, Chronic 1.

 

Boundary composition.002_(Composition of C18:1 amidopropyl betaine containing < 0.1% C18:1 aminopropyl amide)

The target substance (TS) is classified as "hazardous to the aquatic environment", Category Acute 1, according to Commission Regulation (EU) No 286/2011 of 10 March 2011 (second amendment of CLP regulation), as the 96 hour LC50 for fish is lower than 1 mg/L. It is not classified for chronic effects as the TS is readily biodegradable (by read-across) and has experimental log kow of 0.8.