N-(2-hydroxyethyl)-N-[2-[(1-oxooctyl)amino]ethyl]-β-alanine

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

65 µg/L

Assessment factor:

1 000

Extrapolation method:

assessment factor

PNEC freshwater (intermittent releases):

650 µg/L

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

6.5 µg/L

Assessment factor:

10 000

Extrapolation method:

assessment factor

PNEC marine water (intermittent releases):

65 µg/L

STP

Hazard assessment conclusion:

PNEC STP

PNEC value:

1 mg/L

Assessment factor:

100

Extrapolation method:

assessment factor

Sediment (freshwater)

Hazard assessment conclusion:

PNEC sediment (freshwater)

PNEC value:

488 µg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

48.8 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:

59.5 µg/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

 

Short-term toxicity to fish	96 h LC50 > 100 mg a.i./L
Short-term toxicity to aquatic invertebrates	48 h EC50 > 100 mg a.i./L
Toxicity to algae	ErC10 = 0.62 mg a.i./L (95% c.i. 0.32 - 1.21 a.i. mg/L) ErC50 65 mg a.i./L (95% c.i. 42-99 mg/L)

 

PNEC aqua (freshwater), PNEC aqua (marine water)

Three acute studies with freshwater fish, invertebrates and algae are available for Amphopropionate C8, but no long-term or reproduction study. Therefore, in accordance with the Guidance on Information requirements and chemical safety assessment, R.10, an assessment factor of 1000 was applied (10000 for PNEC aqua (marine)), and the PNEC aqua (freshwater) was derived from the 72 hr ErC50 value of 65 mg/L, determined with Pseudokirchneriella subcapitata, the most sensitive of the organisms tested.

 

PNEC (STP)

An activated sludge inhibition test 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 100 was applied to the 3 h EC50 of >100 mg a.i./L resulting in a PNEC STP of 1 mg/L.

 

Soil/sediment

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	302.42
Melting point	no melting point identified
Vapour pressure	<1.47E-03 Pa at 20°C
Water solubility	> 1 kg/L at 20.5°C
Log Kow	weighted mean: 1.1 (< 0.3 to 4.0 at pH 2.0 and < 0.3 to 4.1 at pH 7.0)
PNEC Aqua(freshwater)	0.62 µg/L
PNEC Aqua(marine water)	0.062 µg/L

 

The calculation resulted in a PNEC sediment(freshwater) of 488 µg/kg sediment dw, a PNEC sediment (marine waters) of 48.8 µg/kg sediment dw and a PNEC soil of 59.5 µg/kg soil dw.

 

PNEC oral (secondary poisoning)

Bioaccumulation may be of concern for lipophilic organic substances. Secondary poisoning is concerned with toxic effects at the higher level in the food chain, either living in the aquatic or terrestrial compartment.

However, with a log Kow = 1.1 (weighted mean) the substance doesn’t meet the screening criteria for bioaccumulation, following the Guidance on information requirements and chemical safety assessment, Chapter R.11 (2012).

Therefore, the biomagnification potential of the substance is expected to be low and secondary poisoning is unlikely. Thus, no PNECoral (secondary poisoning) was derived.

 

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 values between 0.1 and 1 mg/L were obtained with algae. Acute toxicity values for fish and crustaceae were >/= 100 mg/L. And the substance is not readily biodegradable. Thus, according to GHS Regulation EC No 1272/2008, Amphopropionate C8 is classified as Aquatic Chronic 2.