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EC number: 209-235-5 | CAS number: 562-74-3
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / micronucleus study
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- In vitro genotoxicity of Melaleuca alternifolia essential oil in human lymphocytes
- Author:
- Pereira T. S., Rocha de Sant'Anna J, Silva E. L., Pinheiro A. L., Alves de Castro-Prado M. A.
- Year:
- 2 014
- Bibliographic source:
- Journal of Ethnopharmacology 151 (2014) 852–857
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 487 (In vitro Mammalian Cell Micronucleus Test)
- Deviations:
- yes
- Remarks:
- no metabolic activation used
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian cell micronucleus test
Test material
- Reference substance name:
- Melaleuca Alternifolia /Tea Tree) Leaf oil
- Cas Number:
- 68647-73-4
- IUPAC Name:
- Melaleuca Alternifolia /Tea Tree) Leaf oil
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- lymphocytes: human
- Details on mammalian cell type (if applicable):
- CELLS USED
- Sex, age and number of blood donors: Male (2), female (1), aged 25 years
- Test concentrations with justification for top dose:
- 95, 182, and 365 µg/ml
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: 24 h
- Exposure duration: 20 h
- Blockage of cytokinesis: At 44 h (with cytochalasin B)
- Incubation time, total: 72 h
ACTIN FILAMENT INHIBITOR: cytochalasin B (final concentration 6 µg/ml)
STAIN: 5% Giemsa (pH 6.8)
NUMBER OF REPLICATIONS: 3
NUMBER OF CELLS EVALUATED: 1000 each (a total of 3000 cells per concentration)
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index
- Any supplementary information relevant to cytotoxicity: Mitotic index was calculated by the number of dividing cells/total number of the cells x 100 - Evaluation criteria:
- The cytokinesis block proliferation index (CBPI) was determined as follows: CBPI=N1+2N2+3(N3+N4)/500, where N1–N4 are the cells with one to four nuclei in 500 cells counted for each experiment.
The amount of cytostasis was determined as follows: % cytostasis=100-100 [(CBPI(T)-1)/(CBPI(C)-1)], where CBPI(T) was the CBPI rate of treatment and CBPI(C) was the CBPI rate of negative control. - Statistics:
- Data were expressed as frequencies of micronuclei and mean +/- standard deviation (SD) of the mean for buds and CBPI rates. Results were statistically analyzed by Z-test and the non-parametric Kruskal–Wallis test (p<0.05).
Results and discussion
Test results
- Species / strain:
- lymphocytes: human
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 365 µg/ml
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
The chemical composition of the tea tree oil was determined and the main constituent was observed to be terpinen-4 -ol with 42.8%.
Applicant's summary and conclusion
- Conclusions:
- Tea tree oil was tested negative under the conditions chosen in this micronucleus assay and thus, was considered to be non-mutagenic.
- Executive summary:
The genotoxic potential of tea tree oil was investigated by the in vitro chromosome aberration assay using human lymphocytes derived from donors. Subjects were non-smoking, non-alcoholic, not under drug therapy and without recent history of exposure to mutagens. Human lymphocytes were treated with three concentrations ( 95, 182, and 365 µg/m) in triplicate. None of the concentrations caused a significant increase in the observed frequencies of micronuclei when compared to the negative control. The positive control mytomicin C induced a significant response. Cytotoxicity was observed at 365 µg/ml.
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