Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
48.7 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
487 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
4.87 µg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
48.7 µg/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
24.1 µg/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:
19.6 µg/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 freshwater aquatic toxicity studies with ETMA were conducted in fish, invertebrates, and algal species. Chronic studies are not available. Fish were the most sensitive trophic level. The PNEC aqua (freshwater) was based on the 96 h LC50 of 48.7 mg/L obtained from the short-term toxicity study in Danio rerio. An assessment factor of 1000 was applied to the LC50 to calculate the PNEC aqua (freshwater) in accordance with Guidance on information requirements and chemical safety assessment, Chapter R.10: Characterisation of dose [concentration]-response for environment, 2008.

 

PNEC aqua (marine)

No tests with marine species are available. The PNEC aqua (marine) was based on the 96 h LC50 of 48.7 mg/L obtained from the short-term toxicity study in Danio rerio. An assessment factor of 10000 was applied to the LC50 to calculate the PNEC aqua (freshwater) in accordance with Guidance on information requirements and chemical safety assessment, Chapter R.10: Characterisation of dose [concentration]-response for environment, 2008.

 

PNEC aqua (intermittent release)

The PNEC aqua (intermittent release) was based on the 96 h LC50 of 48.7 mg/L obtained from the short-term toxicity study in Danio rerio. Based on the available data set, an assessment factor of 100 was applied to the lowest LC50 to calculate the PNEC aqua (intermittent release) in accordance with Guidance on information requirements and chemical safety assessment, Chapter R.10: Characterisation of dose [concentration]-response for environment, 2008.

 

PNEC STP

The PNEC STP was derived using an assessment factor of 10 applied to the EC10 of 72.8 mg/L obtained in an activated sludge respiration inhibition test in accordance with Guidance on information requirements and chemical safety assessment, Chapter R.10: Characterisation of dose [concentration]-response for environment, 2008.

 

PNEC sediment (freshwater, marine)

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

The following data have been taken into account for the calculation:

Molecular weight [g/mol]

158.195

Melting point [°C]

--

Boiling point [°C]

--

Vapour pressure [Pa], 20°C

9.6

Water solubility [mg/L], 20°C

17050

Log Kow

1.8

Koc [L/kg]

13.49 (MCI method)

PNEC aqua, freshwater [mg/L]

0.0487

PNEC aqua, marine [mg/L]

0.00487

 

PNEC soil

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

The following data have been taken into account for the calculation:

Molecular weight [g/mol]

158.195

Melting point [°C]

--

Boiling point [°C]

--

Vapour pressure [hPa], 20°C

9.6

Water solubility [mg/L], 20°C

17050

Log Kow

1.8

Koc [L/kg]

13.49 (MCI method)

  PNEC aqua, freshwater [mg/L]

  0.0487

 

PNEC oral

A PNEC oral was not calculated for ETMA since the substance is readily biodegradable. The probability of being rapidly metabolised in exposed organisms is high. Together with the reported log Kow was 1.8 this indicates that there would be only little biomagnification of the test substance in the food chain.

 

Conclusion on classification

Based on the available reliable and relevant data, short-term toxicity values (L(E)C50) for fish, invertebrates and algae are >1 mg/L. ETMA does not need to be classified for acute toxicity to aquatic organisms according to Regulation EC No 1272/2008 and Directive 67/548/EEC.

No chronic toxicity data are available. However, based on ready biodegradation of ETMA, the criteria for classification for chronic toxicity to aquatic organisms according to Regulation EC No 1272/2008 and Directive 67/548/EEC are not met.