Registration Dossier

Diss Factsheets

Administrative data

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

For the assessment of ecotoxicity of MDEA Esterquat C18 satd. short-term and long-term toxicity data for aquatic, sediment and soil organims are not available. Therefore, ecotoxicity is assessed by read-across to the closely related source substances MDEA-Esterquat C16-18 and C18 unsatd, MDIPA Esterquat C16-18 and C18 unsatd. and MDIPA Esterquat C18 unsatd.. A justification for read-across is given in the aquatic toxicity endpoint summary.

PNEC aqua (freshwater)

Acute and chronic freshwater aquatic toxicity studies 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 (72 h ErC10 inPseudokirchneriella subcapitata= 0.54 mg/L). Based on the available data, a PNECaqua (freshwater) = 0.054 mg/L was calculated.

PNEC aqua (marine water)

Acute and chronic freshwater aquatic toxicity studies 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 (72 h ErC10 in freshwater algae, Pseudokirchneriella subcapitata = 0.54 mg/L). Based on the available data, a PNECaqua (marine water) = 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) of a OECD Guideline 209 study. 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

703 g/mol

Melting point

54°C

Boiling point

250°C

Vapour pressure

1E-06 Pa at 25°C (was set to minimum by EUSES)

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 Aqua(freshwater)

0.054 mg/L

 

PNEC Aqua(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 MDEA-Esterquat C16 -18 and C18 unsatd. 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 of MDEA Esterquat C18 satd. 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

703 g/mol

Vapour Pressure

1,00E-06 Pa at 25°C (was set to minimum by EUSES)

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 very low vapour pressure of the registration substance (<10E-9 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). 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, MDEA Esterquat C18 satd. is assessed to be not a PBT or vPvB substance.

According to GHS Regulation EC No 1272/2008 MDEA Esterquat C18 satd. 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 Pseudokirchneriella 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 read-across substance MDEA-Esterquat C16-18 and C18 unsatd..

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