1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-(C8-18(even numbered) and C18 unsaturated 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

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

0.001 mg/L

Assessment factor:

100

Extrapolation method:

assessment factor

STP

Hazard assessment conclusion:

PNEC STP

PNEC value:

3 000 mg/L

Assessment factor:

1

Extrapolation method:

assessment factor

Sediment (freshwater)

Hazard assessment conclusion:

PNEC sediment (freshwater)

PNEC value:

14.8 mg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

1.48 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:

0.8 mg/kg soil dw

Extrapolation method:

assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

no potential for bioaccumulation

Additional information

Short-term toxicity to aquatic organisms

Taking into account all acute aquatic toxicity data (fish, daphnia and algae) it is the registrants expert judgement that C8-18 AAPB is toxic to aquatic organism, corresponding to Acute Cat. 2 according to the Global Harmonized System (GHS/UN). As this building block is not implemented in Europe, it is not appropriate to classify C8-18 AAPB for acute aquatic effects.

 

Fish: LC50(96 h) = 1.1 mg/L

Invertebrate: EC50(48 h) = 1.9 mg/L

Algae or aquatic plants: ErC50= 1.5 mg/L

 

Long-term toxicity to aquatic organisms

Fish: 37 d/100 d NOEC=0.135 mg/L

Invertebrate: 21 d NOEC=0.3 mg/L

Algae or aquatic plants: 72 h NOEC=0.3 mg/L

 

Biodegradation in water: Readily biodegradable

Bioaccumulation: BCF < 71

logKow: 4.44 (calculated, weighted mean)

 

Ozone layer: Based on the very low vapour pressures of the ionic substances, the atmosphere is not the target compartment of environmental distribution. The registration substance is not expected to reach the atmospheric stratosphere in appreciable amounts where it is rapidly degraded by reaction with OH radicals and therefore is not expected to present a danger to the structure and/or the functioning of the stratospheric ozone layer.

 

Fate

The substance is readily biodegradable. The ready biodegradability of the substance was proven in a number of tests conducted under different conditions (aerobic, anaerobic, marine conditions). Toxicity towards aquatic micro-organisms is expected to be of no concern for sewage treatment plants. Long-term exposure of aquatic organisms is therefore unlikely.

Bioaccumulation in organisms is considered to be low. Therefore, secondary poisoning through the food chain is of no concern for the registration substance.

 

The exposure and uptake of the substance by soil dwelling organisms is unlikely as the target compartment of discharge and environmental distribution is the hydrosphere and the substance is readily biodegradable. Sediment dwelling organisms may be exposed to the test substance, but it can be assumed that the test substance especially the long-chain members are adsorbed onto sediment organic matter and therefore bioavailability will be reduced. Furthermore, based on the available data, bioaccumulation is expected to be low and the test substance proved to be (readily) biodegradable under different conditions (marine water, aerobic, anaerobic).

 

The following data were taken into account for the calculation of sediment and soil PNECs using the equilibrium partitioning method:

Molecular weight	360 g/mol
Vapour pressure	0.0031 hPa at 20°C
Water solubility	250 mg/L at 20°C
Log Kow	4.44 at 20°C
Koc	10931 L/kg
PNECaqua (freshwater)	0.0135 mg/L
PNECaqua (marine)	0.00135 mg/L
PNECsediment(freshwater)	14.8 mg/kg dwt
PNECsediment(marine)	1.48 mg/kg dwt
PNECsoil	2.95 mg/kg dwt

Conclusion on classification

Taking into account all acute aquatic toxicity data (fish, daphnia and algae) it is the registrants expert judgement that C8-18 and C18 unsatd. AAPB is toxic to aquatic organism, corresponding to Acute Cat. 2 according to the Global Harmonized System (GHS/UN). As this building block is not implemented in Europe, it is not appropriate to classify C8-18 and C18 unsatd. AAPB for acute aquatic effects.

C8 -18 and C8 unsatd. AAPB proved to be readily biodegradable.

According to Directive 67/548/EEC, C8 -18 and C8 unsatd. AAPB does not need to be classified as 'dangerous to the aquatic environment' and therefore labelling is not necessary.

According to GHS Regulation EC No 1272/2008, C8 -18 and C8 unsatd. AAPB does not need to be classified with regard to acute environmental effects.

C8 -18 and C8 unsatd. AAPB is classified as hazardous to the aquatic environment (long-term) Aquatic Chronic 3. C8 -18 and C8 unsatd. AAPB does not need to be classified as 'hazardous to the ozone layer.