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EC number: 297-672-2 | CAS number: 93686-22-7 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Citrus reticulata, x C. sinensis, 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
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 5.4 µg/L
- Assessment factor:
- 50
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 5.77 µg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0.54 µg/L
- Assessment factor:
- 500
- Extrapolation method:
- assessment factor
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 2.1 mg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 1.3 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 0.13 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:
- 0.29 mg/kg soil dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- no potential to cause toxic effects if accumulated (in higher organisms) via the food chain
Additional information
All constituents in Tangerine Oil have the same working mechanism (Narcosis and Polar narcosis) and there are no minor constituents that are highly toxic to the environment. In view of the fate and behaviour and risk assessment Limonene, as the major constituent, can be taken as representative for the other constituents.
Tangerine Oil is a complex mixture with limonene as the major constituent. A DPD+ analysis (ref 1) for Tangerine Oil identified limonene to represent the dominant risk to the environment (see table). The ratio calculated from the constituent concentration and concentration limit is called Lead Substance Indicator (LSI). Thus the PNEC for limonene will be used for the risk characterization and the exposure assessment will also be carried out using limonene. PNEC values for limonene are publicly available on the ECHA website (CAS no 5989 -27 -5).
CAS |
Substance |
Conc. in Tangerine oil (%) |
R-phrase(s) |
Conc. limit |
LSI |
5989-27-5 |
Limonene |
88 |
R50/53 |
0.25 |
352 |
(1) REACH: Exposure scenarios for preparations. Methodology for the identification of substances that represent the dominant risks to human health and/or the environment and the drivers for risk management measures, CEFIC, June 09: final for publication
Conclusion on classification
Tangerine Oil is a Natural Complex Substance, a mixture consisting of slightly soluble to soluble constituents. The toxicity of this NCS on algae, daphnia and fish were not experimentally established. For these endpoints read-across was conducted to the citrus oils group. Reliable 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.
Short-term toxicity tests for all three trophic levels are available. For daphnia and algae, the EL50 and ErL50 were 1.1 and 8.0 mg/L, respectively. While the derived 96h-LL50 for fish was 5.65 mg/L. Based on the lowest acute value, in this case daphnia, the substance does not need to be classified for acute aquatic toxicity according to Table 4.1.0 (a) of CLP.
As only one reliable long-term toxicity endpoint is available (ErL10 of 5.1 mg/L) chronic classification needs to be derived on both acute and chronic data, and the worst case should be taken. Based on the ErL10 value, the substance does not need to be classified for chronic toxicity. The substance is readily biodegradable, however has a log Kow ranging 3.38 - 4.88 and the lowest acute toxicity value is 1.1 mg/L for daphnia which, on the basis of constituents with log Kow > 4, would lead to classification Aquatic Chronic 2 (H411).
Based on the available aquatic toxicity studies, Tangerine oil needs to be classified for the environment as Aquatic Chronic 2 (H411) according to EU CLP (EC 1272/2008) and its amendments. M factor for acute and chronic toxicity are not applicable.
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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