Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
60 ng/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
30 ng/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
6 ng/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
300 ng/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
7.4 mg/kg sediment dw
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.74 mg/kg sediment dw
Assessment factor:
1 000
Extrapolation method:
assessment factor

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.095 mg/kg soil dw
Assessment factor:
1 000
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
0.125 mg/kg food
Assessment factor:
90

Additional information

Predicted No Environmental Effect Concentrations (PNECs) have been calculated using the results of environmental toxicity tests and applying default assessments factors. Many of the tests were conducted using solubilising agents to increase solubility of the test substance whose water solubility is limited. There are concerns that the use of such agents does not necessarily result in exposure and values used are instead based on the stated water solubility of the substance, this assumed to be the "water accomodated fraction" and more representative of exposure.

Conclusion on classification

Classification for environmental effects is not justified based on the lack of toxicity in acute tests in three aquatic aquatic compartments and long-term tests in two aquatic compartments. While the substance is not readily biodegradable there is evidence that degradation does occur, although relatively slowly. It is possible that the rate of biodegradation may be limited by the rate of hydrolysis of the test substance and/or the rate with which the substance dissolves. Modelling of possible biodegradation pathways indicate that aerobic degradation is likely, the first steps in this being hydrolysis to trimellitic acid and 2 -ethylhexanol, both of which have been shown to be readily biodegradable.