Registration Dossier
Registration Dossier
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EC number: 205-711-1 | CAS number: 148-24-3
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1967/1968 and 1969
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- publication
- Title:
- Sensibilisierungen und Gruppensensibilisierungen durch Chinolinderivate
- Author:
- Pevny, I. and Schellenberg, J.
- Year:
- 1 971
- Bibliographic source:
- Der Hautarzt 22 (1):13 - 18
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- - Principle of test: Patch test
- Parameters observed: skin reaction after application of the test substance - GLP compliance:
- no
Test material
- Reference substance name:
- Quinolin-8-ol
- EC Number:
- 205-711-1
- EC Name:
- Quinolin-8-ol
- Cas Number:
- 148-24-3
- Molecular formula:
- C9H7NO
- IUPAC Name:
- quinolin-8-ol
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Name of test material (as cited in publication): Chinosol®-Solution
Method
- Type of population:
- other: Patients
- Ethical approval:
- no
- Subjects:
- First test series (1967 - 1968):
- Number of subjects exposed: 127
Second test series (1969):
- Number of subjects: 100
- Other: Subjects also included patients for whom previous topical use was not certain but only probable
Third test series: (1969):
- Number of subjects: 100 - Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
Results and discussion
- Results of examinations:
- NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
First test series:
- Number of subjects with positive reactions: 6
- Number of subjects with negative reactions: 121
Second test series:
- Number of subjects with positive reactions: 8
- Number of subjects with negative reactions: 92
Third test series:
- Number of subjects with positive reactions: 6
- Number of subjects with negative reactions: 94
- Number of subjects with irritating reactions: 6 (2/6: light erythema, 3/6: erythema, 1/6: erythema + edema + paupules + vesicles)
Applicant's summary and conclusion
- Conclusions:
- CLP: Skin sens 1, H317
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