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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- 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:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
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:
- - Description: Clear colourless liquid.
- Source: Not specified.
- Batch No. of test material: D266
- Purity: 100%
- Expiration date of the batch: 30 November 2014
- Storage condition of test material: Approximately 4°C in the dark.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Hsdlf:NZW
- Details on test animals or tissues and environmental conditions:
- - Source: Harlan Laboratories UK Ltd., Leicestershire, UK
- Age at study initiation: Twelve to twenty weeks old
- Weight at study initiation: 2.79 kg or 2.85 kg
- Housing: The animals were individually housed in suspended cages.
- Diet: Free access to food (2930C Teklad Global Certified Rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon, UK) was allowed throughout the study. The diet was considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
- Water: Free access to mains drinking water was allowed throughout the study. The drinking water was considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
- Acclimation period: At least five days.
- Identification: Each animal was given a number unique within the study which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label.
- Temperature: The temperature was set to achieve limits of 17 to 23°C. Any occasional deviations from this target were considered not to have affected the purpose or integrity of the study.
- Humidity: The relative humidity was set to achieve limits of 30 to 70%. Any occasional deviations from this target were considered not to have affected the purpose or integrity of the study.
- Air changes: At least 15 changes per hour.
- Photoperiod: Lighting was controlled by a time switch to give 12 hours continuous light (06:00 to 18:00) and 12 hours darkness.
- Enrichment: The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
- Justification for chosen species: The albino rabbit has been shown to be a suitable model for this type of study and is recommended in the test method. The results of the study are believed to be of value in predicting the likely irritancy potential of Tea Tree Oil to man.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- Amount applied: 0.1 mL Tea Tree Oil
- Duration of treatment / exposure:
- Tea Tree Oil was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of Tea Tree Oil, and then released.
- Observation period (in vivo):
- Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment.
- Number of animals or in vitro replicates:
- Two rabbits.
- Details on study design:
- - Scoring system: Immediately after administration of Tea Tree Oil, an assessment of the initial pain reaction was made according to the six point scale shown in the attached Appendix 1. Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the Draize Scale for Scoring Ocular Irritation (see the attached Appendix 2).
- Tool used to assess score: Light source from a standard opthalmoscope.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- Individual and group mean scores for ocular irritation are given in Table 1 and Table 2 (see 'Any other information on results'). No corneal or iridial effects were noted during the study. Moderate conjunctival irritation was noted in both treated eyes one hour after treatment with minimal conjunctival irritation noted at the 24 and 48-hour observations. Both treated eyes appeared normal at the 72-hour observation.
- Other effects:
- Individual bodyweights and bodyweight changes are given in Table 3 (see 'Any other information on results'). One animal showed a slight bodyweight loss while the other animal showed expected gain in bodyweight during the study.
Any other information on results incl. tables
Table 1. Individual Scores and Individual Total Scores for Ocular Irritation.
Rabbit Number and Sex | 72426 Male | 42463 Male | ||||||
IPR = 2 | IPR = 2 | |||||||
Time After Treatment | 1 Hour | 24 Hours | 48 Hours | 72 Hours | 1 Hour | 24 Hours | 48 Hours | 72 Hours |
CORNEA | ||||||||
E = Degree of Opacity | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
F = Area of Cornea Involved | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Score (E x F) x 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
IRIS | ||||||||
D | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Score (D x 5) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
CONJUNCTIVAE | ||||||||
A = Redness | 2 | 2 | 1 | 0 | 2 | 1 | 1 | 0 |
B = Chemosis | 1 | 1 | 0 | 0 | 1 | 1 | 0 | 0 |
C = Discharge | 1 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
Score (A + B + C) x 2 | 8 | 6 | 2 | 0 | 10 | 4 | 2 | 0 |
Total Score | 8 | 6 | 2 | 0 | 10 | 4 | 2 | 0 |
IPR = initial pain reaction
Table 2. Individual Total Scores and Group Mean Scores for Ocular Irritation.
Rabbit Number and Sex | Individual Total Scores At: | |||
1 Hour | 24 Hours | 48 Hours | 72 Hours | |
72426 Male | 8 | 6 | 2 | 0 |
42463 Male | 10 | 4 | 2 | 0 |
Group Total | 18 | 10 | 4 | 0 |
Group Mean Score | 9.0 | 5.0 | 2.0 | 0.0 |
Table 3. Individual Bodyweights and Bodyweight Changes.
Rabbit Number and Sex | Individual Bodyweight (kg) | Bodyweight Change (kg) | |
Day 0 | Day 3 | ||
72426 Male | 2.85 | 2.82 | -0.03 |
42463 Male | 2.79 | 2.93 | 0.14 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Tea Tree Oil produced a maximum group mean score of 9.0 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. Tea Tree Oil does not meet the criteria for classification according to the Globally Harmonised System of Classification and Labelling of Chemicals or Regulation (EC) No 1272/2008, relating to the Classification, Labelling and Packaging of Dangerous Substances.
- Executive summary:
A GLP-compliant study was performed to assess the irritancy potential of Tea Tree Oil to the eye of the New Zealand White rabbit following the in vitro Bovine Corneal Opacity and Permeability study (Harlan Laboratories Ltd Project number 41104699) which showed the test item not be corrosive or severely irritating to the eye. The method was designed to be compatible with OECD Testing Guideline No. 405 "Acute Eye Irritation/Corrosion" and EU Method B.5 Acute Toxicity (Eye Irritation). A single application of Tea Tree Oil to the non-irrigated eye of two rabbits produced moderate conjunctival irritation. Both treated eyes appeared normal at the 72-hour observation. Tea Tree Oil produced a maximum group mean score of 9.0 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. Tea Tree Oil does not meet the criteria for classification according to the Globally Harmonised System of Classification and Labelling of Chemicals or Regulation (EC) No 1272/2008, relating to the Classification, Labelling and Packaging of Dangerous Substances.
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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