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EC number: 285-377-1 | CAS number: 85085-48-9 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Melaleuca alternifolia, Myrtaceae.
- 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
Partition coefficient
Administrative data
- Endpoint:
- partition coefficient
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.8 (Partition Coefficient)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 117 (Partition Coefficient (n-octanol / water), HPLC Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.7570 (Partition Coefficient, n-octanol / H2O, Estimation by Liquid Chromatography)
- Deviations:
- no
- GLP compliance:
- yes
- Type of method:
- HPLC method
- Partition coefficient type:
- octanol-water
Test material
- Reference substance name:
- Melaleuca alternifolia, ext.
- EC Number:
- 285-377-1
- EC Name:
- Melaleuca alternifolia, ext.
- Cas Number:
- 85085-48-9
- Molecular formula:
- Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance).
- IUPAC Name:
- Essential oil of melaleuca alternifolia
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Purity: 100%
- Lot (batch) No.: 1215
- Expiration date of the lot: 30 March 2009
- Storage condition of test material: Room temperature, protected from light.
Study design
- Analytical method:
- high-performance liquid chromatography
Results and discussion
Partition coefficientopen allclose all
- Type:
- Pow
- Partition coefficient:
- >= 2 510 - <= 314 000
- Temp.:
- 30 °C
- Remarks on result:
- other: The effect of pH on the partition coefficient was not assessed since the test substance does not possess a dissociation constant in environmental pH ranges.
- Type:
- log Pow
- Partition coefficient:
- >= 3.4 - <= 5.5
- Temp.:
- 30 °C
- Remarks on result:
- other: See above
- Details on results:
- The mean calibration curve was used to interpolate the results (see attached Figure 1). The mean calibration curve produced was log10Pow = 3.05 log10k + 2.45, where k = capacity factor = t1r / to = (tr - to) / to, and t1r = true retention time obtained by subtracting deadtime, or t0, of I.D.S. from measured retention time of sample or reference.
Figure 2 and Figure 3 (see attached) present examples of chromatograms of the standard mixture and test substance generated during this test.
The test substance eluted as a series of peaks between approximately 8 and 30 minutes and consequently the partition coefficient was reported as a range for the compounds. The range of log10 Pow values obtained for Tea Tree Oil was 3.4 to 5.5.
On analysis of the component substances, which represented the principal components of the test substance, the following retention times were obtained together with the calculated log10 Pow values:
- Alpha-terpineol: Retention time = 8.1 minutes, log10 Pow = 3.4
- Terpinen-4-ol: Retention time = 8.5 minutes, log10 Pow = 3.5
- Alpha-terpinene: Retention time = 24.5 minutes, log10 Pow = 5.2
- Gamma-terpinene: Retention time = 25.8 minutes, log10 Pow = 5.3
The chromatogram obtained for cineole showed that the compound was not detected by the HPLC method.
Applicant's summary and conclusion
- Conclusions:
- The range of partition coefficient values for Tea Tree Oil was found to be 2510 to 314000 (log10 Pow = 3.4 to 5.5).
- Executive summary:
A GLP-compliant study was carried out to determine the partition coefficient of Tea Tree Oil. The study followed the requirements of EEC method A8, OECD method 117 and OPPTS method 830.7570 without significant deviation. The range of partition coefficient values for Tea Tree Oil was found to be 2510 to 314000 (log10 Pow = 3.4 to 5.5).
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