Registration Dossier

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
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2003

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
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Rectified Camphor oil

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.