Registration Dossier

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:
documentation insufficient for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

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:
In 10 people the patches were applied to the back or inner side of the upper arm and covered in an airtight manner with bandage material. The patches were applied 48 hours apart for a total of 5 applications (6 including the first patch test). Each patch was removed after 24 hours and the site scored. Following a 10 day rest, a final patch was applied.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 10
Controls:
no
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: 6 times each with 48 hour interval and after 10 days

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 10
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0

Applicant's summary and conclusion

Conclusions:
Under the conditions of this study, the test article did not induce contact dermal sensitization in human subjects.
Executive summary:

The purpose of this study was to determine the epicutaneous irritation potential of the test article in humans. In 10 people used in a primary irritation study (Hopf, 1974), additional patches were applied. The patches were applied to the back or inner side of the upper arm (the same location as the primary irritation study) and covered in an airtight manner with bandage material. The patches were applied 48 hours apart for a total of 5 applications (6 including the first patch test). Each patch was removed after 24 hours and the site scored. Following a 10 day rest, a final patch was applied. Under the conditions of this study, the test article did not induce contact dermal sensitization in human subjects. There was no skin reactivity noted during the study.