Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
1.47 µg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.006 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:
0.003 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Relevant data used for calculation of PNECs

Fish: 96 h LC50 >100 mg/L

Invertebrate: 48 h EC50 >100 mg/L

Algae: 72 h ErC50 = 14.7 mg a.i./L (95% c.l. 12.4 - 17.5 mg a.i./L)

72 h ErC10 = 4.42 mg a.i./L (95% c.l.3.70 - 5.18 mg a.i./L)

72 h NOEC = 1.3 mg a.i./L

 

Biodegradation in water: Readily biodegradable

Bioaccumulation: not expected based on log Kow <3

Log Kow: -1.38 (calculated)

 

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

Three acute studies with freshwater fish, invertebrates and algae are available for Undecylenamidopropyl Betaine, 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 72 h ErC50 of 14.7 mg/L, determined with Desmodesmus subspicatus, the most sensitive of the organisms tested. This results in a PNECaqua (freshwater) of 14.7 µg/L.

An assessment factor of 10000 was applied resulting in a PNECaqua (marine water) of 1.47 µg/L.

An assessment factor of 100 was applied resulting in a PNECaqua (Intermittent release) of 147 µg/L.

 

PNEC STP

A test on ready biodegradation including a toxicity control conducted with the source substance C8-10 Amidopropyl-betaine is available. In accordance with the Guidance on information requirements and chemical safety assessment, Chapter R.10: Characterisation of dose [concentration]-response for environment, 2008, an assessment factor of 10 was applied to the 14 d NOEC obtained in the Ready Biodegradability test of 45 mg a.i./L resulting in a PNEC STP of 4.5 mg/L.

 

PNEC air

The registration substance has a low vapour pressure of 1.52E-12 Pa at 25°C. Due to the ionic structure and a corresponding low vapour pressure of the substance a relevant concentration of the substance in the atmospheric compartment is not expected. Based on this, no risk for air breathing animals and humans is expected.

 

PNECoral (secondary poisoning)

Bioaccumulation potential has been estimated to be low based on the log Kow of -1.38. 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, 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

327.48 g/mol

Melting point

144°C

Vapour pressure

1.52E-12 Pa at 25°C (set to minimum value of 1E-06 in EUSES)

Water solubility

3100 mg/L at 20°C

Log Kow

-1.38 (set to minimum value of -1 in EUSES)

PNEC Aqua(freshwater)

14.7 µg/L

PNEC Aqua(marine water)

1.47 µg/L

 

The calculation resulted in a PNEC sediment(freshwater) of 0.0576 mg/kg sediment dw, a PNEC sediment (marine waters) of 5.76E-03 mg/kg sediment dw and a PNEC soil of 2.89E-03 mg/kg soil dw.

Conclusion on classification

Based on acute toxicity values >1 mg/L, no classification for aquatic acute toxicity is required according to GHS Regulation EC No 1272/2008.

Chronic toxicity data are available only for algae. The substance is readily biodegradable, and the log Kow is -1.38. Thus, according to GHS Regulation EC No 1272/2008, no classification for aquatic chronic toxicity is required.