Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
1.54 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
1 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.154 mg/L
Assessment factor:
500

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.736 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:
0.566 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 toxicity studies were conducted with Ethyltriglycol methacrylate in fish and algae. Chronic studies with Ethyltriglycol methacrylate are available for algae and aquatic invertebrates. Algae is the most sensitive trophic level in acute studies and Daphnia magna in chronic studies.

The PNEC aqua (freshwater) was based on the EC10 of 77.1 mg/L determined in a long term daphnia magna reproduction test.

Two chronic studies were available for this substance, which covered two trophic levels (algal and invertebrates). Since similar short-term toxicity was observed between 2 trophic levels (fish and algae) with all L(E)C50 values >100 mg/l, an assessment factor of 50 was applied to the EC10 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 EC10 of 77.1 mg/L determined in a daphnia magna reproduction test. Two chronic studies were available for this substance, which covered two trophic levels (algal and invertebrates). Since similar short-term toxicity was observed between 2 trophic levels (fish and algae) with all L(E)C50 values >100 mg/l, an assessment factor of 500 was applied to the EC10 to calculate the PNEC aqua (marine) 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 lowest acute toxicity value of 100 mg/L for (72 h LC50, algae, growth rate). 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

In an OECD guideline 301 F biodegradation test 100 mg/L of Ethyltriglycol methacrylate did not inhibit microbial activity. There was no bacterial toxicity at the highest concentration tested. As a consequence concentration from biodegradation test with Ethyltriglycol methacrylate was used (100 mg/l.) with an assessment factor of 10. 

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]

246.31

Melting point [°C]

<-20

Boiling point [°C]

292

Vapour pressure [Pa], 20°C

0.077

Water solubility [mg/L], 20°C

61441

Log Kow

2.08

Koc (Kow method) L/kg

54.73

PNEC aqua, freshwater[mg/L]

1.54

PNEC aqua, marine [mg/L]

0.154

 

 

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]

246.31

Melting point [°C]

<-20

Boiling point [°C]

292

Vapour pressure [Pa], 20°C

0.077

Water solubility [mg/L], 20°C

61441

Log Kow

2.08

Koc (Kow method) L/kg

54.73

PNEC aqua, freshwater[mg/L]

1.54

 

 

 

PNEC oral

A PNEC oral was not calculated for Ethyltriglycol methacrylate since the substance is readily biodegradable. The probability of being rapidly metabolised in exposed organisms is high. Together with the reported log Pow was 2.08 indicates that there would be no relevant 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 and algae are >1 mg/L. Ethyltriglycol methacrylate does not need to be classified for acute toxicity to aquatic organisms according to Directive 67/548/EEC or Regulation EC No 1272/2008.

Based on the available reliable and relevant data, long-term toxicity values (EC10) for aquatic invertebrates and algae are > 1 mg/L, and Ethyltriglycol methacrylate is readily biodegradable. Thus, Ethyltriglycol methacrylate does not need to be classified for chronic toxicity to aquatic organisms according to Regulation EC No 1272/2008.

No classification for chronic toxicity to aquatic organisms according to Directive 67/548/EEC is required based on the available short-term toxicity values (> 1 mg/L) and ready biodegradability.