Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
1 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
18.9 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:
36.9 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The interpretation of the results of the available Daphnia reproduction study is complicated by the rapid disappearance of test material in the system. Based on the instability of the test material and this decline/disappearance of the test material during the test, it is considered that the test should not be regarded reliable without restriction. Due to this the results from this study have will not be used in the calculation of PNEC's.

An acute Daphnia magna study using a passive dosing technique (O-rings) has now been conducted and obtained stable concentrations throughout the test duration. This acute study is therefore considered more relevant for environmental assessment than the Daphnia magna reproduction study and has therefore been used as the basis for PNEC derivation.

Conclusion on classification

Following the EU CLP regulation, the substance does not need to be classified as hazardous to the aquatic environment, based on the available data on the substance.

Based on reported acute test results for fish (96 hr LC50 of 4.4 mg/L), algae (96 hr ErC50 of 7.6 mg/L) and key daphnia magna study (48 hr EC50 1.3 mg/L) for substance does not meet the criteria for classification as Acute Category 1 (requiring an acute result <= 1 mg/L).

A chronic classification is not required as although the acute toxicity studies provide results within the classification criteria, as the substance is readily biodegradable and is assessed to be non-bioaccumulative, the criteria for a chronic classification is not met.

The results of a Daphnia reproduction study, although not reliable without restriction, also does not support classification.