Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: no details available, 1% test substance

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
human patch test; 11 applications with 1% test substance
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Blankophor BBU
- Analytical purity: no data

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 102
- Sex: females
Route of administration:
dermal
Details on study design:
11 applications, 1% diluted test substance, 3.23 cm²

Results and discussion

Results of examinations:
None of the individuals showed any reaction caused by the test substance treatment.
Neither irritation potential nor sensitisation potential could be demonstrated.

Applicant's summary and conclusion