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Diss Factsheets
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EC number: 277-143-2 | CAS number: 72968-50-4 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Citrus aurantium, Rutaceae.
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Hazard for air
Hazard for terrestrial organisms
Hazard for predators
Additional information
Orange Oil Bitter is a Natural Complex Substance, a mixture consisting of slightly soluble to soluble constituents. The volume is 1-10 tonnes/year, therefore no PNEC is derived and no Hazard assessment or PBT assessment is conducted.
Conclusion on classification
Orange Oil Bitter is a Natural Complex Substance, a mixture consisting of slightly soluble to soluble constituents. The toxicity of this NCS on algae and Daphnia was not experimentally established. Also for fish, which is not required for this volume, no experimental data were available. For these endpoints read-across was conducted to the group of citrus oils. Data are available for Orange Oil, Mandarin oil and Lime oil. The justification of this read-across is described in detail in the read-across justification document.
For Orange Oil Bitter, the lowest ecotoxicity value (from a range of results for the various citrus oils) is a 48h-EL50 from a Daphnia WAF study with Orange Oil. In this study the 48h-EL50 is 1.1 mg/L. All other studies for citrus oils used for read-across gave higher ecotoxicity values, with EL50 values between 5 and 12 mg/l.
This leads to a classification with R51.
The test substance Orange Oil Bitter was shown to be readily biodegradable.
As all known constituents of Orange Oil Bitter have an estimated log Kow >3 (log Kow over 4 for 90% of the constituent composition) and no measured data on BCF is available for Orange Oil Bitter, it is also classified as R53.
Thus according to Directive 67/548/EEC Orange Oil Bitter is classified as R51/53 (Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment).
According to Regulation 1272/2008/EC (CLP) Orange Oil Bitter is classified as hazardous to the aquatic environment Chronic Category 2 (H411).
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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