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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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- 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:
- Melaleuca oil (tea tree oil) dermatitis
- Author:
- Knight, T. E., Hausen B. M.
- Year:
- 1 994
- Bibliographic source:
- Journal of the American Academy of Dermatology, (1994) Vol. 30, No. 3, pp. 423-427
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Principle of test: Patch test
- Short description of test conditions: The patients were patch tested to the standard battery of 20 allergens, a 1% solution of pure Tea tree oil (TTO) in anhydrous ethyl alcohol, a 1% concentration of 11 of the constituent compounds found in highest concentrations in the essential oil of TTO, and a 5% concentration of d-carvone.
- Parameters analysed: Erythema and oedema reactions - GLP compliance:
- no
Test material
- Reference substance name:
- p-menth-1-en-4-ol
- EC Number:
- 209-235-5
- EC Name:
- p-menth-1-en-4-ol
- Cas Number:
- 562-74-3
- Molecular formula:
- C10H18O
- IUPAC Name:
- 4-methyl-1-(propan-2-yl)cyclohex-3-en-1-ol
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source: Haarman & Reimer, Holzminden, Germany
- Purity: at least 99%
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 7
- Sex: male and female
- Age: 48 (2/7), 51 (1/7), 55 (1/7), 56 (1/7), 57 (1/7), 68 (1/7)
- Race: 2 Filipino, 5 probably white
- Demographic information: USA - Clinical history:
- - History of allergy or casuistics for study subjects: The patients treated skin conditions, such as foot fungus, insect bites, hand rashes, dog scratches, and "pimples" of the legs. All patients initially had an eczematous dermatitis consisting of ill-defined plaques of erythema, edema, and scaling; in three patients vesiculation was also present
- Exposure history: All patients had applied 100% pure melaleuca oil which was commercially available.
- Any other allergic or airway disorders: not specified
- Smoking history: not specified - Controls:
- Ethanol, olive oil, and a blank Finn Chamber patch was used. 20 control patients were treated.
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive / semiocclusive /other: not specified
- Description of patch: not specified
- Vehicle / solvent: anhydrous ethyl alcohol, olive oil
- Concentrations: 1% solutions (100% pure TTO, the 11 constituent compounds of TTO); 5% (d-carvone); 5% and 10% (constituent compounds, 6/7 patients)
- Volume applied: not specified
- Testing/scoring schedule: reading 50 h after application
- Removal of test substance: Allergens were applied for 48 h
EXAMINATIONS
- Grading/Scoring system: not specified
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: Erythema and induration in one patient (1% group) and two patients (10% group), respectively.
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 1; 2
- Number of subjects with negative reactions: 6; 4 (inframmammary/chest was not tested with one patient)
- Number of subjects with equivocal reactions: 3
- Number of subjects with irritating reactions: 3
RESULT OF CASE REPORT: The test substance was a less frequent sensitizer.
Any other information on results incl. tables
Table 1: Patch test results of terpinen-4 -ol
Patient No |
Age (yr)/Sex/race |
Location of eczema |
Reactions |
|
concentrations |
||||
1% |
10% |
|||
1 |
48/F/W |
Inframammary, chest |
N |
ND |
2 |
56/F/W |
Arm |
N |
N |
3 |
51/F/Fil |
Hands, arms, torso |
+2 |
+2 |
4 |
68/F/W |
Legs |
N |
+2 |
5 |
57/M/W |
Arms, neck, face |
N |
N |
6 |
55/M/Fil |
Groin, foot, chest |
N |
N |
7 |
48/F/W |
Flanks, legs, arms |
N |
N |
F = female; M = male; Fil = Filipino; W = White; N = negative; ND = not done; +2 = erythema and induration
Applicant's summary and conclusion
- Conclusions:
- The most common melaleuca oil allergen of the tested constituent compounds was d-limonene followed by aromadendrene and alpha-terpinene. Terpienen-4-ol was a less frequent sensitizer.
- Executive summary:
The objective of the present study was to investigate which constituent compounds of melaleuca oil (tea tree oil) were responsible for allergic contact eczema in seven patients becoming sensitized. These seven patients were treated with Finn chambers in a patch test to a 1% solution (vol/vol) of melaleuca oil and 1% solutions (vol/vol) of 11 constituent compounds. From seven patients reacting to the 1% melaleuca oil solution, six patients also reaacted to d-limonene, five to alpha-terpinene and aromadendrene, two to terpinen-4 -ol, and one each to p-cymene and alpha-phellandrene. d-Carvone caused no reactions among the seven patients. The most common allergen was found to be d-limonene causing allergic contact eczema in the patients.
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