Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
7.32 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:
0.006 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

PNECs were derived based on test data following standard guidelines. All data are considered to be reliable and relevant for the endpoint concerned.

 

Short-term aquatic data in freshwater are available for three trophic levels for the test item. The most sensitive endpoint was determined to be fish, with a 96-hour LC50 of 14.1 mg/L (Scheerbaum 2016). This endpoint was used to derive the PNECs for freshwater, marine water and intermittent releases by assessment factor method, and freshwater sediment, marine sediment and soil by equilibrium partitioning approach.

 

For derivation of the PNEC for STP, the NOEC of 20 mg/L was taken from the toxicity control of a ready biodegradability test. A PNEC of 2.0 mg/L is derived by applying an assessment factor of 10.

 

The test item has low vapour pressure (0.0045, 0.0096 and 0.29 Pa at 20, 25 and 50°C, respectively (Smeykal 2014), therefore it is not a precursor to ozone formation and is not expected to be a significant contribution to global warming. The test item is not an ozone depleting substance as defined by the Montreal Protocol and does not contain chemical constituents that would lead to acidification.

 

No hazard is expected from secondary poisoning. The measured log Kow value of 1.99 indicates that the test item is not potentially bioaccumulative. Since the test item has no bioaccumulation potential, a secondary poisoning assessment is not required.

Conclusion on classification

Chronic toxicity data are available for freshwater algae for the substance (72 -h EC10 = 22.7 mg/L, Scheerbaum, 2015). The test item achieved biodegradation of 60 % after 3 days, meeting the 10-day window within 28 day test period and therefore is considered to be readily biodegradable. Based ready biodegradation and chronic EC10 of 22.7 mg/L the substance does not need to be classified as hazardous to the aquatic environment.

Acute aquatic data are available for three trophic levels for the test item. The most sensitive endpoint was determined to be fish, with a 96-hour LC50 of 14.1 mg/L (Scheerbaum 2016). The effect value for the most sensitive trophic level in the acute aquatic dataset is > 10 to ≤ 100 mg/L, however the substance is readily biodegradable and has log Kow below the trigger value of 4, therefore the test item is not classified as hazardous to the aquatic environment.