Registration Dossier

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:
1971
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
Name:
Unnamed
Type:
Constituent
Test material form:
solid
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