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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1976
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Study meets generally accepted scientific principles, but detailed results and discussion on test item was not reported.
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:
Unnamed
Year:
1976

Materials and methods

Type of sensitisation studied:
skin
Study type:
other: patients
Principles of method if other than guideline:
Two hundred consecutive patients and 50 subjects positive to balsams were tested with the 35 essential oils most frequently used in Polish cosmetics and sensitisation was studied.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Juniper, Juniperus communis, ext.
EC Number:
283-268-3
EC Name:
Juniper, Juniperus communis, ext.
Cas Number:
84603-69-0
Molecular formula:
Not applicable for UVCB
IUPAC Name:
Juniper, Juniperus communis, ext.
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Juniper berries

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 200 consecutive patients with dermatitis; 50 other subjects positive to one or more of four balsams (which comprised balsam of Peru, wood tars, colophony and turpentine).
Controls:
None
Route of administration:
dermal
Details on study design:
- All these patients were tested with the 35 essential oils which were used at a concentration of 2 % in yellow soft paraffin.

Results and discussion

Results of examinations:
- Of the 20 patients positive to balsam of Peru and negative to other balsams, one patient showed positive reactions to Juniper.
- Of the 23 patients positive to turpentine and negative to other balsams, one patient showed positive reactions to Juniper.
- Of the 31 patients positive to turpentine, one patient showed positive reactions to Juniper.
- Of the 31 patients positive to balsam of Peru, one patient showed positive reactions to Juniper.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:
Under the test conditions, Juniper oil induced skin sensitization in human.
Executive summary:

Two hundred consecutive patients and 50 subjects positive to balsams were tested with the 35 essential oils including Juniper berries.

Of the 20 patients positive to balsam of Peru and negative to other balsams, one patient showed positive reactions to Juniper. Of the 23 patients positive to turpentine and negative to other balsams, one patient showed positive reactions to Juniper. Of the 31 patients positive to turpentine, one patient showed positive reactions to Juniper. Of the 31 patients positive to balsam of Peru, one patient showed positive reactions to Juniper.

 

Under the test conditions, Juniper oil induced skin sensitization in human.