Registration Dossier
Registration Dossier
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EC number: 205-524-5 | CAS number: 142-16-5
Ecotoxicological Summary
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
- 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.
For the classification of bis(2 -ethylhexyl) maleate, the following data were taken into account:
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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