Registration Dossier
Registration Dossier
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EC number: 202-860-4 | CAS number: 100-52-7
Sensitisation data (human)
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:
- 1 977
- 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 substance name:
- Benzaldehyde
- EC Number:
- 202-860-4
- EC Name:
- Benzaldehyde
- Cas Number:
- 100-52-7
- Molecular formula:
- C7H6O
- IUPAC Name:
- benzaldehyde
- Details on test material:
- No data given
Constituent 1
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.
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