Ethanaminium, 2-hydroxy-N-(2-hydroxyethyl)-N,N-dimethyl-, esters with C16-18 and C18-unsatd. fatty acids, chlorides

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

0.054 mg/L

Assessment factor:

10

Extrapolation method:

assessment factor

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

0.005 mg/L

Assessment factor:

100

Extrapolation method:

assessment factor

STP

Hazard assessment conclusion:

PNEC STP

PNEC value:

4.74 mg/L

Assessment factor:

10

Extrapolation method:

assessment factor

Sediment (freshwater)

Hazard assessment conclusion:

PNEC sediment (freshwater)

PNEC value:

109 mg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

10.9 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:

534 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 PNECaqua:

Short-term toxicity to aquatic organisms

LC50 (96 h) = 5.2 mg/L for Danio rerio (OECD 203)

EC50 (24 h) = 14.8 mg/L for Daphnia magna (OECD 202/ Part I)

ErC50 (72 h) = 1.2 mg/L for Pseudokirchnerella subcapitata (OECD 201; read-across MDIPA Esterquat C18 unsatd.)

Long-term toxicity to aquatic organisms

NOEC (35 d) = 0.686 mg/L for Pimephales promelas (US EPA TSCA, 40 CFR, Part 797.1600)

NOEC (21 d) = 1.0 mg/L for Daphnia magna (EPA OTS 797.1330)

EC10 (72 h) = 0.54 mg/L for Pseudokirchnerella subcapitata (OECD 201; read-across MDIPA Esterquat C18 unsatd.)

PNEC aqua (freshwater)

Results from acute and chronic tests 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 is justified. Based on the results with the most sensitive organism (Pseudokirchnerella subcapitata EC10 (72h) = 0.54 mg/L) and taking into account the assessment factor 10, a PNECaqua (freshwater)=0.054 mg/L was calculated.

 

PNEC aqua (marine)

Results from acute and chronic tests with freshwater organisms (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 is justified. Based on the results with the most sensitive organism (Pseudokirchnerella subcapitata EC10 (72h) = 0.54 mg/L) and taking into account the assessment factor 100, a PNECaqua (marine waters)=0.0054 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

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 NOEC value (>47.4 mg a.i./L). The calculation yields a PNECmicroorganisms > 4.7 mg/L.

 

PNEC sediment (freshwater), PNEC sediment (marine waters)

No toxicity data for sediment dwelling organisms are available. Thus, the PNEC for freshwater and marine sediment has been calculated with the equilibrium partitioning method using EUSES 2.1.

The following data have been taken into account for calculation:

Molecular Weight	697 g/mol
Vapour Pressure	1,00E-09 Pa at 25°C
Water solubility	17.6 mg/L at 19.7°C
Koc	20225 L/kg (geometric mean of the two sludges and the two soils)
PNEC freshwater	0.054 mg/L
PNEC marine water	0.0054 mg/L

 

PNEC soil

Terrestrial toxicity values, although scientifically robust, are in this case not relevant for the derivation of the PNECsoil. No effects were seen at the highest concentrations tested (earthworms, higher plants), which was 47.4 mg/kg dry weight. It is expected that the potential for effects to occur in the terrestrial environment due to MDEA-Esterquat C16-18 and C18 unsatd. are minimal and the corresponding PNECsoil is higher as derived with EPM.

The PNECsoil is estimated via the equilibrium partitioning method using EUSES 2.1.

The following data have been taken into account for calculation:

Molecular Weight	697 g/mol
Vapour Pressure	1,00E-09 Pa at 25°C
Water solubility	17.6 mg/L at 19.7°C
Koc	494 x 10E03 L/kg (geometric mean of the two soils)
PNEC freshwater	0.054 mg/L

 

PNEC Air

Due to the ionic structure and a corresponding negligible vapour pressure of the substance a relevant concentration of the substance in the atmospheric compartment is not expected.

 

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 (TGD, part II, chap 3, page 343).

Due to the low calculated BCF (BCF = 70.8 L/kg (BCFWIN v2.17) and the low BCF of 12-256 L/kg for similar substances, the bioaccumulation in organisms is anticipated to be low. Therefore, the biomagnification potential of the substance is expected to be low and secondary poisoning is unlikely for MDEA-Esterquat C16-18 and C18 unsatd. and no PNECoral (secondary poisoning) was derived.

Conclusion on classification

Based on reliable, relevant and adequate data, MDEA-Esterquat C16-18 and C18 unsatd. is assessed to be not a PBT or vPvB substance.

According to GHS Regulation EC No 1272/2008 MDEA-Esterquat C16-18 and C18 unsatd.  has to be classified as “hazardous to the aquatic environment”, chronic 3 (H412, Harmful to aquatic life with long lasting effects) based on the 72h EC10 of 0.54 mg/L for Pseudokirchnerella subcapitata, obtained with the read-across substance MDIPA Esterquat C18 unsatd. and the 35 d NOEC of 0.686 mg/L for Pimephales promelas, obtained with the target substance MDEA-Esterquat C16-18 and C18 unsatd..

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