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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Principle of test: The study was conducted to determine the skin irritation index of tea tree oil in the rabbit by the Draize method.
- Short description of test conditions: The undiluted test item was applied to the intact and abraded skin of six New Zealand White rabbits.
- Parameters analysed / observed: Skin irritation reactions and clinical signs of toxicity or abnormal behaviour. - GLP compliance:
- no
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:
- - Batch no.: 88/375
- Purity: 100%
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Source: Not specified.
- Age at study initiation: Young mature albino rabbits were used.
- Weight at study initiation: Not specified.
- Housing: Not described.
- Diet: Not specified.
- Water: Not specified.
- Acclimation period: Not specified.
- Temperature: 22°C.
- Humidity: Not specified.
- Air changes: Not specified.
- Photoperiod: Not specified.
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- other:
- Remarks:
- Abraded and intact skin were examined for each animal.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- Dose: 0.5ml.
Concentration: 100% (undiluted). - Duration of treatment / exposure:
- 72 hours.
- Observation period:
- All animals were observed for signs of toxicity and abnormal behaviour during the experimental period. The observation period is not specified.
- Number of animals:
- 6 animals.
- Details on study design:
- Procedure: P.C.S method number 1 was used.
Area of exposure: Not specified.
Removal of test substance: Not described.
Observation time points: 24 hours and 72 hours.
The Draize scale for scoring skin reactions is shown in the attached scoring system.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24/72 h
- Score:
- 2.5
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Timepoints
- Remarks:
- Only 24 h and 72 h timepoints were reported
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Timepoints
- Remarks:
- Only 24 h and 72 h timepoints were reported
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24/72 h
- Score:
- 3.5
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Timepoints
- Remarks:
- Only 24 h and 72 h timepoints were reported
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #4
- Remarks:
- mean
- Time point:
- other: 24/72 h
- Score:
- 3.5
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Timepoints
- Remarks:
- Only 24 h and 72 h timepoints were reported
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #5
- Remarks:
- mean
- Time point:
- other: 24/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Timepoints
- Remarks:
- Only 24 h and 72 h timepoints were reported
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- animal #6
- Remarks:
- mean
- Time point:
- other: 24/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Timepoints
- Remarks:
- Only 24 h and 72 h timepoints were reported
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24/72 h
- Score:
- 1.5
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- other: Timepoints
- Remarks:
- Only 24 h and 72 h timepoints were reported
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- other: Timepoints
- Remarks:
- Only 24 h and 72 h timepoints were reported
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- other: Timepoints
- Remarks:
- Only 24 h and 72 h timepoints were reported
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- animal #4
- Remarks:
- mean
- Time point:
- other: 24/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- other: Timepoints
- Remarks:
- Only 24 h and 72 h timepoints were reported
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- animal #5
- Remarks:
- mean
- Time point:
- other: 24/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- other: Timepoints
- Remarks:
- Only 24 h and 72 h timepoints were reported
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- animal #6
- Remarks:
- mean
- Time point:
- other: 24/72 h
- Score:
- 1.5
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- other: Timepoints
- Remarks:
- Only 24 h and 72 h timepoints were reported
- Irritant / corrosive response data:
- Irritation reactions were observed on both intact and abraded skin after treatment with the test sample. The primary irritation index was found to be 5.0.
Any other information on results incl. tables
Table 1. Details on skin irritation reactions.
Animal No. | Intact Skin | Abraded Skin | Score | Time of Evaluation | ||
Erythema | Oedema | Erythema | Oedema | |||
1 | 2 | 1 | 2 | 1 | 6 | 24 hours |
3 | 2 | 3 | 2 | 10 | 72 hours | |
2 | 3 | 2 | 3 | 2 | 10 | 24 hours |
3 | 2 | 3 | 2 | 10 | 72 hours | |
3 | 3 | 2 | 3 | 2 | 10 | 24 hours |
4 | 2 | 4* | 2 | 12 | 72 hours | |
4 | 3 | 2 | 3 | 3 | 11 | 24 hours |
4 | 2 | 4* | 2 | 12 | 72 hours | |
5 | 3 | 2 | 3 | 2 | 10 | 24 hours |
3 | 2 | 4* | 2 | 11 | 72 hours | |
6 | 3 | 2 | 3 | 2 | 10 | 24 hours |
3 | 1 | 4 | 2 | 10 | 72 hours | |
Total | 28 | 29 | 57 | 24 hours | ||
31 | 34 | 65 | 72 hours | |||
Index | 4.7 | 4.8 | 4.8 | 24 hours | ||
5.2 | 5.7 | 5.4 | 72 hours |
Primary Irritation Index: 5.0
* erosion
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Given mean values for erythema at 24 and 72 hours of more than 2.3 in all treated animals, Tea Tree Oil is considered to be a Category 2 Irritant.
- Executive summary:
Acute dermal irritation testing was carried out on six young mature albino rabbits (NZ). The test sample was administered undiluted, as supplied. All animals were observed for signs of toxicity and abnormal behaviour during the experimental period. Irritation reactions were observed on both intact and abraded skin after treatment with the test sample. The Draize irritation index was found to be 5.0, indicating a severe irritant. Based on GHS criteria, and given mean values for erythema at 24 and 72 hours of more than 2.3 in all treated animals, Tea Tree Oil is considered to be a Category 2 Irritant.
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