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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Limited reported, only 5 subjects studied

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1977
Report Date:
1977

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:
The investigation was conducted on adult patients of both sexes with chronic urticaria. A closed patch test with 5% the test substance in petrolatum was applied to the upper part of the back for a period of 30 min. The result was read immediately after removal and after every hour until the reaction disappeared. Effect of an antihistamine was also studied.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No data given

Method

Type of population:
other: patients
Ethical approval:
confirmed and informed consent free of coercion received
Subjects:
- Number of subjects exposed: five
- Sex: both sexes

No additional data
Clinical history:
- History of allergy or casuistics for study subject or populations: The patients with continuous or recurrent symptoms of more than 3 months’ duration and with varying dermatoses.

No additional data
Controls:
None stated
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Vehicle / solvent: petrolatum
- Concentrations: 5%
- Testing/scoring schedule: The result was read immediately after removal and after every hour until the reaction disappeared.
- Other: A closed patch test was applied to the upper part of the back for a period of 30 min.

No additional data

Results and discussion

Results of examinations:
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 1
- Number of subjects with negative reactions: 4

No additional data

Any other information on results incl. tables

Number of immediate reactions before and after treatment with clemastine

 

Conc. %

Before

After

The test substance

5

1

-

 

Applicant's summary and conclusion

Conclusions:
The test substance gave rise to urticarial reaction. The effect of antihistamine was that the reactions were not always inhibited but were diminished.
Executive summary:

The investigation was conducted on adult patients of both sexes with chronic urticaria. A closed patch test with 5% the test substance in petrolatum was applied to the upper part of the back for a period of 30 min. The result was read immediately after removal and after every hour until the reaction disappeared. Effect of an antihistamine was also studied.

The test substance gave rise to urticarial reaction. The effect of antihistamine was that the reactions were not always inhibited but were diminished.