Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.069 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.067 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.007 mg/L
Assessment factor:
100
Extrapolation method:
sensitivity distribution

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
6.8 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
57.97 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
5.797 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:
75.4 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 aquatic organisms

LC50 (96 h) >11.7 mg a.i./L for Danio rerio (OECD 236)

EC50 (48 h) = 6.7 mg/L for Daphnia magna (OECD 202)

ErC50 (72 h) = 8.1 mg/L for Pseudokirchneriella subcapitata (OECD 201)

 

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)

ErC10 (72 h) = 2.7 mg/L for Pseudokirchneriella subcapitata (OECD 201)

 

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 (Pimephales promelas, 35 d NOEC = 0.686 mg/L). Based on the available data, a PNECaqua (freshwater) = 0.0686 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 (Pimephales promelas, 35 d NOEC = 0.686 mg/L). Based on the available data, a PNECaqua (marine water) = 0.00686 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 (48 h EC50 = 6.7 mg/L for Daphnia magna) in accordance with the Guidance on information requirements and chemical safety assessment R10. Based on the available data, a PNEC aqua (intermittent releases) = 0.067 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 tests (goem. mean of three studies) of 68 mg a.i./L resulting in a PNEC STP of 6.8 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.

Based on the PNECaqua (freshwater) = 0.0686 mg/L, the PNEC sediment(freshwater) was calculated to be 57.97 mg/kg sediment dw; the PNEC sediment (marine waters) was calculated to be 5.58 mg/kg sediment dw.

 

The following data have been taken into account for calculation:

 

Molecular Weight

761

Melting point

36°C

Vapour Pressure

8.4E-7 Pa at 20°C

Water solubility

3.4 mg/L at 20°C

Log Kow

4.43

Koc

4914.79 L/kg

Solids-water partition coefficient in soil

1099 L/kg

Solids-water partition coefficient in sediment

992.52 L/kg

Solids-water partition coefficient suspended matter  841.51 L/kg
Solids-water partition coefficient in raw sewage sludge  23.57 L/kg
Solids-water partition coefficient in settled sewage sludge  23.57 L/kg
Solids-water partition coefficient in activated sewage sludge  29.07 L/kg

Solids-water partition coefficient in effluent sewage sludge

 29.07 L/kg

PNEC freshwater

0.0686 mg/L

PNEC marine water

 0.00686 mg/L

  

 

 

PNEC Air

Due to the ionic structure and a corresponding negligible vapour pressure of the substance (<8.4E-7 Pa at 20°C) 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 (TGD, part II, chap 3, page 343).

However, with a log Kow = 4.4 for MDIPA-Esterquat C16-18 and C18 unsatd., 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 for MDIPA-Esterquat C16-18 and C18 unsatd., and no PNECoral (secondary poisoning) was derived.

Conclusion on classification

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

According to GHS Regulation EC No 1272/2008 MDIPA-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 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”.

 

According to Directive 67/548/EEC, classification as R51/53 is required if:

-acute toxicity values between 1 and 10 mg/L are obtained for fish or Daphnia or algae

and

-the substance is not readily degradable or

-the log Kow > 3.0 (unless the experimentally determined BCF <100).

Acute toxicity values between 1 and 10 mg/L were obtained for Daphnia and algae. The substance is readily biodegradable, but the log Kow is > 3. As the substance has a low bioaccumulation potential based on the measured BCF of a closely related substance of 13 L/kg, no classification is required for MDIPA-Esterquat C16-18 and C18 unsatd.