Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
7.56 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:
13.9 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)

Three acute studies with the freshwater organisms fish, Daphnia and alga are available for the test item, but no long-term or reproduction study. Therefore, in accordance with the Guidance on Information requirements and chemical safety assessment, R.10, an assessment factor of 1000 was applied and the PNEC aqua (freshwater) was derived from the 96 h LC50 value of 2.02 mg/L, determined with Danio rerio, the most sensitive of the organisms tested. This results in a PNECaqua (freshwater) of 2.02 µg/L.

 

PNEC aqua (marine)

Three acute studies with the freshwater organisms fish, Daphnia and alga are available for the test item, but no long-term or reproduction study. Therefore, in accordance with the Guidance on Information requirements and chemical safety assessment, R.10, an assessment factor of 10000 was applied and the PNEC aqua (marine) was derived from the 96 h LC50 value of 2.02 mg/L, determined with Danio rerio, the most sensitive of the organisms tested. This results in a PNECaqua (marine) of 0.202 µg/L.

 

PNEC aqua (intermittent release)

Acute tests with fish, aquatic invertebrates and algae are available. In accordance with the Guidance in Information requirements and chemical safety assessment, R.10, an assessment factor of 100 was applied to the lowest L(E)C50, which was the 96 h LC50 in Danio rerio of 2.02 mg/L. Thus, the PNECaqua(Intermittent release) was calculated to be 20.2 µg/L.

 

PNEC STP

The PNEC STP was based on the 3 h EC10 of 31.7 mg/L obtained in a respiration inhibition test with activated sludge. Based on the available data, an assessment factor of 10 was applied in accordance with the Guidance in Information requirements and chemical safety assessment, R.10, to calculate the PNEC STP = 3.17 mg/L.

 

PNEC air

The registration substance has a low vapour pressure of <1E-05 Pa at 25°C. Based on this no risk for air breathing animals and humans is expected.

 

PNECoral (secondary poisoning)

Bioaccumulation potential has been estimated to be low. There is no concern for secondary poisoning and therefore no PNECoral (secondary poisoning) was derived.

 

PNEC sediment(freshwater), PNEC sediment (marine waters), PNEC soil

No toxicity tests with sediment dwelling or terrestrial organisms are available. Thus, in accordance with the Guidance on information requirements and chemical safety assessment, Chapter R.10: Characterisation of dose [concentration]-response for environment, 2008, the PNEC for freshwater and marine water sediment as well as the PNEC soil have been calculated with the equilibrium partitioning method using EUSES 2.1.

 

The following data have been taken into account for calculation:

 

A molecular formula, molecular weight range and SMILES notation cannot be given as the substance is a mixture. However, for the purpose of chemical safety assessment a weighted molecular weight of 331 g/mol (weighted arithmetic mean) was calculated taking into account the molecular weight of the main components and their average percentage.

 

Molecular weight

 

ca. 331 g/mol (weighted mean)

Melting point

 

4.7 to 7.4 °C (268.5 to 280.6 K)

Vapour pressure

 

< 1E-05 Pa at 25°C

Water solubility

 

10.13 - 25.99 mg/L at 20.2°C

Log Kow

 

2.902 – 3.058 at 25°C

PNEC Aqua(freshwater)

 

2.02 µg/L

PNEC Aqua(marine water)

 

0.202 µg/L

 

Using a water solubility of 25.99 mg/L and a log Kow of 2.902, the calculation resulted in a PNEC sediment(freshwater) of 75.6 µg/kg sediment dw, a PNEC sediment (marine waters) of 7.56 µg/kg sediment dw and a PNEC soil of 13.9 µg/kg soil dw. Using a lower water solubility resulted in slightly higher PNECs for sediment and soil

Conclusion on classification

The lowest acute toxicity value is the 96 h LC50 to Danio rerio of 2.02 mg/L.

Based on this result and the substance being not rapidly biodegradable, Epoxy half acrylatehas to be classified as Aquatic Chronic 2 and labelled with H411 ”Toxic to aquatic life with long lasting effects” according to Regulation EC No 1272/2008.

According to Directive 67/548/EEC Epoxy half acrylate has to be classified as R51 - Toxic to aquatic organisms and R53 - May cause long-term adverse effects in the aquatic environment.