Registration Dossier
Registration Dossier
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EC number: 287-316-4 | CAS number: 85480-37-1 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Melaleuca leucadendron, Myrtaceae.
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2002
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only short abstract available
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- Gas Chromatography: An Investigative Tool in Multiple Allergies to Essential Oils.
- Author:
- Dharmagunawardena B, Takwale A, Sanders KJ, Cannan S, Rodger A and Ilchyshyn A
- Year:
- 2 002
- Bibliographic source:
- Contact Dermatitis. 47(5): 288-292
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- case report
- Principles of method if other than guideline:
- Method: Single Patch test performed in patients
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Cajuput, ext.
- EC Number:
- 287-316-4
- EC Name:
- Cajuput, ext.
- Cas Number:
- 85480-37-1
- IUPAC Name:
- 1,3,3-trimethyl-2-oxabicyclo[2.2.2]octane; 2-(4-methylcyclohex-3-en-1-yl)propan-2-ol
- Test material form:
- other: oil
- Details on test material:
- - Name of test material (as cited in study report): Cajuput oil
Constituent 1
Method
- Type of population:
- other: clinical cases presented with suspected allergic contact dermatitis
- Controls:
- No
- Route of administration:
- dermal
Results and discussion
- Results of examinations:
- - In 51 years old female, cajuput oil showed oedematous/vesicular reaction on Day 4 and it was found to be composed of α-pinene (>1 %), terpineol (>10 %) and caryophylene (> 1%).
- In second patient, it showed ulcerative/bullous reaction and found to be composed of α-pinene (>0.1 %), terpineol (>1 %) and caryophylene (> 0.1 %).
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- In 51 years old female, cajuput oil showed oedematous/vesicular reaction on Day 4 and it was found to be composed of α-pinene (>1 %), terpineol (>10 %) and caryophylene (> 1%). In second patient, it showed ulcerative/bullous reaction and found to be composed of α-pinene (>0.1 %), terpineol (>1 %) and caryophylene (> 0.1 %).
- Executive summary:
In a skin sensitisation study, two female patients (51 and 52 year old professional aromatherapists presented with suspected allergic contact dermatitis) were applied with occlusive patches containing cajuput oil diluted in white petrolatum, for 48 h. The reactions were observed at 30 min. after removal of patches and on Day 4. The composition of the oil was analysed using GC-MS chromatography.
In 51 years old female, cajuput oil showed oedematous/vesicular reaction on Day 4 and it was found to be composed of α-pinene (>1 %), terpineol (>10 %) and caryophylene (> 1%). In second patient, it showed ulcerative/bullous reaction and found to be composed of α-pinene (>0.1 %), terpineol (>1 %) and caryophylene (> 0.1 %).
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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