Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.16 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:
0.239 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

EGDMA is readily biodegradable in OECD screening tests (> 60 % biodegradation within 28 days, but 10 days window failed). According CLP criteria the substance is not readily biodegradable.

No bioaccumulation expected based on log Pow of 2.4.

Based on the available reliable and relevant data, short-term toxicity values (L(E)C50) for fish [LC50 (96h): 15.95 mg/l], daphnia magna [EC50 (48h): 44.9 mg/l) and algae [EC50: 17.3 mg/l] ) are >1 mg/L. EGDMA does not need to be classified for acute toxicity to aquatic organisms according to Regulation EC No 1272/2008.

Chronic aquatic toxicity studies are available for daphnia magna and algae. NOEC daphnia magna: 5.05 mg/l, NOEC algae: 6.93 mg/l. No chronic data are available for fish. The toxicological mechanism is based on narcosis because no specific toxicity has been observed in acute aquatic toxicity tests at all three trophic levels. Therefore no deviating chronic toxicity is expected in chronic fish tests as based on acute data, fish and algae are of similar aquatic toxicity and log Pow 2.4 . No chronic toxicity <= 1 mg/l is expected.

In summary based on expert judgement no classification for environmental toxicity is required for Ethyleneglycol dimethacrylate.