Registration Dossier
Registration Dossier
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EC number: 941-396-3 | CAS number: -
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 1 mg/L
- Assessment factor:
- 100
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 1 mg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0.1 mg/L
- Assessment factor:
- 1 000
- Extrapolation method:
- assessment factor
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 10 mg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 448.406 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 44.841 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:
- 364 mg/kg soil dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- no potential for bioaccumulation
Additional information
All PNECs are derived using the standard approach as indicated by the "Guidance on information requirements and chemical safety assessment Chapter R.10: Characterisation of dose [concentration]-response for environment" (ECHA, 2012). For water, a lower assessment factor is applied due to known behaviour and function of triglycerides in fresh water and marine environment.
However, for sediment and soil no additional safety factor is used, as the PNEC assessment is based on a worst case approach. The available studies represent sufficient indications that any toxicity of the substance High oleic sunflower oil, maleated is expected to become apparent > 100 mg/L.
Based on the absence of any adverse effects up to the highest dose tested in the available toxicological long-term studies and the toxicokinetic profile of High oleic sunflower oil, maleated, no bioaccumulation is expected.
Conclusion on classification
No toxicological effects have been observed in all available studies on aquatic toxicity of up to the maximum tested dose of 100 or 150 mg/L, respectively. High oleic sunflower oil, maleated can not be regarded as readily biodegradable, but it is expected to be cleaved into into glycerol and mono-or diglycerids and fatty acids upon uptake by aquatic organisms. Thus, based on the toxicokinetic profile no bioaccumulation is expected. Thus, the available data on environmental toxicity of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
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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