1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-C8-10 (even numbered) acyl derivs., hydroxides, inner salts

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

0.013 mg/L

Assessment factor:

10

Extrapolation method:

assessment factor

PNEC freshwater (intermittent releases):

0.015 mg/L

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

0.001 mg/L

Assessment factor:

100

Extrapolation method:

assessment factor

PNEC marine water (intermittent releases):

0.002 mg/L

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:

0.246 mg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

0.025 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:

0.042 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

Short-term toxicity to fish	96 h LC50 >100 mg a.i./L
Long-term toxicity to fish	100 d NOEC = 0.135 mg a.i./L
Short-term toxicity to aquatic invertebrates	48 h EC50 = 1.9 mg a. i./L
Long -term toxicity to aquatic invertebrates	21 d NOEC = 0.3 mg a.i./L
Toxicity to aquatic algae and cyanobacteria	72 h ErC50 = 1.5 mg a.i./L 72 h NOEC = 0.3 mg a.i./L

 

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

Acute and chronic freshwater aquatic toxicity studies with fish, Daphnia and algae are available for the substance itself or closely related source substances. 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 lowest chronic toxicity value (fish early life stage test: 100 d NOEC = 0.135 mg a.i./L). Based on the available data, a PNECaqua (freshwater) = 0.0135 mg/L was calculated.

 

For derivation of the PNECaqua (marine water) an assessment factor of 100 was applied to the lowest chronic toxicity value (fish early life stage test: 100 d NOEC = 0.135 mg a.i./L). Based on the available data, a PNECaqua (marine water) = 0.00135 mg/L was calculated.

 

PNEC aqua (intermittent release)

Acute freshwater aquatic toxicity studies with fish, Daphnia and algae are available. An assessment factor of 100 was applied to the lowest value of acute freshwater ecotoxicity test results (72 h ErC50 = 1.5 mg a.i./L in algae) in accordance with the Guidance on information requirements and chemical safety assessment R10. Based on the available data, a PNEC aqua (intermittent releases) = 0.015 mg/L was calculated.

PNEC STP

A test on ready biodegradation including a toxicity control 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 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 PNEC sediment(freshwater) was calculated to be 0.246 mg/kg sediment dw; the PNEC sediment (marine waters) was calculated to be 0.0246 mg/kg sediment dw; the PNEC(soil) was calculated to be 0.0421 mg/kg soil dw.

 

The following data have been taken into account for calculation:

Molecular Weight	297 mg/mol (weighted mean)
Melting point	n.a. (decomposition in the range between 60 and 260°C)
Vapour Pressure	0.0031 hPa at 20°C
Water solubility	4.9 g/L at 20°C (CMC)
Log Kow	2.2 at 20°C
PNEC freshwater	0.0135 mg/L
PNEC marine water	0.00135 mg/L

  

 

 

PNEC Air

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.

 

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 = 2.2 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, and the substance is readily biodegradable. Thus, according to GHS Regulation EC No 1272/2008, C8-10 Alkylamidopropyl betaine is classified as Aquatic Chronic 3.