Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.002 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.018 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:
0.027 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)

Freshwater aquatic toxicity studies with TREGDMA were conducted in fish, invertebrates, and algal species. Acute toxicity studies were conducted in fish and algae. Chronic studies are available for algae and invertebrates. Aquatic invertebrates were the most sensitive trophic level in chronic studies. However, in short-term studies fish was the most sensitive trophic level. The lowest overall toxicity value was the LC50 in Danio rerio.The PNEC aqua (freshwater) was based on the LC50 of 16.4 mg/L determined in a short term toxicity study with Danio rerio. Two chronic studies were available for this substance, which covered two trophic levels (algal and invertebrates). An assessment factor of 100 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 toxicity tests for TEGDMA with marine species are available. The The PNEC aqua (marine) was based on theLC50 of 16.4mg/L determined in a short term toxicity study with Danio rerio. Two chronic studies were available for this substance, which covered two trophic levels (algal and invertebrates). However, the LC50 in fish was lower than the EC10 or NOECs obtained in long-term studies in algae and invertebrates. Thus, an assessment factor of 1000 was applied to the LC50 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 16.4 mg/L for Danio rerio (96 h EC50). Based on the available data set, an assessment factor of 100 was applied to the lowest EC50 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

No appropriate microbial inhibition test data are available for TREGDMA. In a CO2 evolution OECD guideline 301B biodegradation test, the substance applied at a concentration of 17.03 mg/L was found to be readily biodegradable based on 85% degradation after 28 days. The results not only indicate the substance is readily biodegradable, but by default suggests no inhibition of microorganisms at 17.03 mg/L. Moreover a biodegradation test from a structurally related substance (Diethyleneglycol methacrylate) including a toxicity control is available. In this ready biodegradability test, 100 mg/L of the test substance did not inhibit microbial activity.

PNEC STP was derived using an assessment factor of 10 applied to the test concentration at which no toxicity to the inoculum was observed in the ready biodegradation tests (100 mg/L) 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]

286.33

Melting point [°C]

-88.00

Boiling point [°C]

 

Vapour pressure [hPa], 20°C

0.077

Water solubility [mg/L], 20°C

3600

Log Kow

2.30

Koc (Kow method)

76.72

PNEC aqua, freshwater[mg/L]

0.0164

PNEC aqua, marine [mg/L]

0.00164

 

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]

286.33

Melting point [°C]

-88.00

Boiling point [°C]

 

Vapour pressure [hPa], 20°C

0.077, 20°C

Water solubility [mg/L], 20°C

3600, 20°C

Log Kow

2.30

Koc (Kow method)

76.72

PNEC aqua, freshwater[mg/L]

0.00164

 

PNEC oral

A PNEC oral was not calculated for TREGDMA since the substance is readily biodegradable. The probability of being rapidly metabolised in exposed organisms is high. Together with the reported log Kow was 2.3 this indicates that there would be only little or no 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. TREGDMA does not need to be classified for acute toxicity to aquatic organisms according to 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 TREGDMA is readily biodegradable. Thus, TREGDMA does not need to be classified for chronic toxicity to aquatic organisms according to Regulation EC No 1272/2008.