1-Propanaminium, 2-hydroxy-N-(2-hydroxypropyl)-N,N-dimethyl-, esters with C18-unsatd. fatty acids, Me sulfates (salts)

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

0.017 mg/L

Assessment factor:

10

Extrapolation method:

assessment factor

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

0.002 mg/L

Assessment factor:

100

Extrapolation method:

assessment factor

STP

Hazard assessment conclusion:

PNEC STP

PNEC value:

10 mg/L

Assessment factor:

100

Extrapolation method:

assessment factor

Sediment (freshwater)

Hazard assessment conclusion:

PNEC sediment (freshwater)

PNEC value:

1.7 mg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

0.17 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:

0.331 mg/kg soil dw

Extrapolation method:

equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

no potential for bioaccumulation

Additional information

PNEC aqua (freshwater)

Acute and chronic freshwater aquatic toxicity studiestests with fish, Daphnia and algae are 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 lowest chronic toxicity value (21 -day EC10 in Daphnia magna = 0.166 mg/L). Based on the available data, a PNECaqua (freshwater) = 0.0166 mg/L was calculated.

 

PNEC aqua (marine water)

Acute and chronic freshwater aquatic toxicity studiestests with fish, Daphnia and algae are 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 lowest chronic toxicity value (21 -dayEC10 in Daphnia magna = 0.166 mg/L).

Based on the available data, a PNECaqua (marine water) = 0.00166 mg/L was calculated.

PNEC aqua (intermittent release)

A PNEC aqua (intermittent release) was not calculated as the registration substance has a wide dispersive use. Intermittent releases are therefore not relevant.

 

PNEC STP

Arespiration inhibition test according to EU method C.11 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 1000 mg/L resulting in a PNEC STP of 10 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 following data have been taken into account for calculation:

Molecular weight	796 g/mol
Melting point	-10°C
Boiling point	200°C
Vapour poressure	1E-06 Pa at 20°C (was set to minimum by EUSES)
Water solubility	1.22 mg/L at 20°C
Log Kow	3.8
PNEC Aqua(freshwater)	0.0166 mg/L
PNEC Aqua(marine water)	0.00166 mg/L

PNEC Air

Due to the very low vapour pressure of the registration substance (5E-08 Pa at 20°C) the risk for air breathing animals and humans is expected to be negligible.

 

Secondary poisoning

Bioaccumulation potential has been estimated to be low (BCF = 71 L/kg wet-wt). There is no concern for secondary poisoning and therefore no PNECoral (secondary poisoning) was derived.

Conclusion on classification

Based on reliable, relevant and adequate data, MDIPA Esterquat C18 unsatd. is assessed to be not a PBT or vPvB substance.

According to GHS Regulation EC No 1272/2008 MDIPA Esterquat C18 unsatd. has to be classified as “hazardous to the aquatic environment”, chronic 3 (H412, Harmful to aquatic life with long lasting effects).

The substance does not need to be classified as “hazardous to the ozone layer”.