Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically acceptable method

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Human repeated insult patch test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: powder
- Analytical purity: no data provided

Method

Type of population:
general
Controls:
no data
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: repeated insult patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive (3.0 cm x 3.0 cm)
- Concentrations: 10 mg/cm²
- Testing/scoring schedule: 15 applications and one challenge were done
- Removal of test substance: no data

EXAMINATIONS
- Grading/Scoring system:
0 = No reaction.
1+ = Slight erythema.
2+ = Marked erythema.
3+ = Marked erythema, edema, with or without a few vesicles.
4+ = Marked erythema, edema, with vesicles and oozing.

Results and discussion

Results of examinations:
SYMPTOMS
No visible skin changes signifying reaction to injury were observed in any of the subjects after any application.

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions. 50
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0

Applicant's summary and conclusion