Registration Dossier
Registration Dossier
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EC number: 295-980-1 | CAS number: 92201-50-8 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Cinnamomum camphora, Lauraceae.
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2003
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Only short abstract available
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- other: case report and patch testing
- Principles of method if other than guideline:
- A 64 year-old woman presented with severe eczema of the ears, neck and upper chest following the use of Earex ear drops containing rectified camphor oil along with other ingredients. Patch testing was performed with ear drops and rectified camphor oil (10 % in petrolatum) and skin reactions were observed. Subsequently, a further 30 patients attending the patch test clinic were tested to the same rectified camphor oil.
- GLP compliance:
- no
Test material
- Reference substance name:
- Camphor tree, ext.
- EC Number:
- 295-980-1
- EC Name:
- Camphor tree, ext.
- Cas Number:
- 92201-50-8
- IUPAC Name:
- 1,3,3-trimethyl-2-oxabicyclo[2.2.2]octane; 1-methyl-4-(prop-1-en-2-yl)cyclohex-1-ene; 2,6,6-trimethylbicyclo[3.1.1]hept-2-ene
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): Rectified Camphor oil
Constituent 1
Method
- Type of population:
- general
- Controls:
- None
- Route of administration:
- dermal
Results and discussion
- Results of examinations:
- - One female (n=1) showed positive reactions on Day 2 and Day 4 to 10 % camphor oil in petrolatum.
- A further 30 patients attending the patch clinic were tested to the same camphor oil as is and none developed positive reactions.
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, patch testing with rectified camphor oil showed one skin sensitization case in human.
- Executive summary:
In a study, a 64 year-old woman presented with severe eczema of the ears, neck and upper chest following the use of Earex ear drops containing rectified camphor oil along with other ingredients. Patch testing was performed with ear drops and rectified camphor oil (10 % in petrolatum) and skin reactions were observed. Subsequently, a further 30 patients attending the patch test clinic were tested to the same rectified camphor oil.
One female (n=1) showed positive reactions on Day 2 and Day 4 to 10 % camphor oil in petrolatum. A further 30 patients attending the patch clinic were tested to the same camphor oil as is and none developed positive reactions.
Under the test conditions, patch testing with rectified camphor oil showed one skin sensitization in human.
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