Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
23.4 µg/L
Assessment factor:
500
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
38.8 µg/L

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:
5.17 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.517 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:
0.897 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), PNEC aqua (marine), PNEC aqua (intermittent release)

There are acute aquatic toxicity data available from studies in green alga (freshwater), Daphnia (freshwater) and fish (freshwater). Long-term study data are available for green alga (freshwater) and Daphnia (freshwater). Therefore, in accordance with the Guidance on Information requirements and chemical safety assessment, R.10, an assessment factor of 50 was applied and the PNEC aqua (freshwater) was derived from the NOEC value of 11.7 mg/L, determined with Daphnia, the most sensitive of the organisms tested. This results in a PNEC aqua (freshwater) of 0.234 mg/L.

An assessment factor of 100 was applied to the lowest EC50, which was the 48 h EC50 in Daphnia (freshwater). Thus, the PNEC aqua (intermittent release) was calculated to be 0.388 mg/L. 

An assessment factor of 500 was applied and the PNEC aqua (marine) was derived from the NOEC value of 11.7 mg/L, determined with Daphnia, the most sensitive of the organisms tested. This results in a PNEC aqua (marine) of 0.0234 mg/L. 

An assessment factor of 1000 was applied to the lowest EC50, which was the 48 h EC50 in Daphnia (freshwater). Thus, the PNEC aqua (intermittent release) was calculated to be 0.0388 mg/L. 

PNEC STP

According to Guidance R.10, an assessment factor of 10 was applied to the test concentration at which no toxicity was observed in an OECD 301F guideline study (100 mg/L).

PNEC air

The substance has a low vapour pressure of 1.1E-17 Pa at 25 °C (Mackay method, QSAR). Based on this, no risk for air breathing animals and humans is expected.

PNEC secondary poisoning

Direct oral exposure to the test item in the environment is not expected. Furthermore, the test item was found to be readily biodegradable. Hence, indirect exposure through the food chain is considered unlikely.

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 by default (PNEC calculator plug-in). 

Conclusion on classification

As the acute aquatic toxicity of the test item is > 1 mg/L for all trophic levels that have been investigated (algae, Daphnia, fish), the test item is not classified for acute aquatic hazard according to Regulation (EC) No 1272/2008, Annex I, section 4. Data on chronic toxicity are available for two trophic levels. NOEC values for algae and Daphnia are both > 1 mg/L. The substance is readily biodegradable and is thus not classified for long-term aquatic hazard.