Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
1.595 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:
3.19 mg/kg soil dw
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
20 mg/kg food
Assessment factor:
300

Additional information

PNECs were derived for freshwater, saltwater, sediment, and soil using either experimental results or equilibrium partitioning calculations. The PNECoral for birds and mammals was derived from a 28 -day repro screening study conducted with rats

Conclusion on classification

For the classification of bis(2 -ethylhexyl) maleate, the following data were taken into account:

  • aquatic toxicity: EC50 of 0.619 mg/L, derived from an algae study
  • biodegradation: ready biodegradable but failing the 10-day window criterion
  • partitioning coefficient: Log Pow of 7.24, derived from experimental data
  • bioaccumulation: BCF of 4073.8 L/kg, based on QSAR estimation.

Although the BCF is not derived experimentally, it is considered as relevant for classification and labelling as it can be expected that an experimentally derived BCF would also result in a value far above the relevant trigger value of 500 L/kg.

Based on the available data, bis(2 -ethylhexyl) maleate is classified as chronic category 1. For the classification of a mixture containing bis(2 -ethylhexyl) maleate, a multiplying factor of 1 has to be used for the substance.