Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Test procedures cannot be subsumed under a testing guideline. The test method is scientifically acceptable, nevertheless the report is not well documented and no many details are included.

Data source

Reference
Reference Type:
publication
Title:
Fluorescent Whitening Agents. Tests for skin-sensitizing potential.
Author:
Griffith J.F.
Year:
1973
Bibliographic source:
Arch. Dermatol. 107, 728-733

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 65 subjects.
Controls:
The vehicle also was applied as a negative control. No positive control was applied.
Route of administration:
dermal
Details on study design:
TYPE OF TEST USED: repeated insult patch test.

ADMINISTRATION
- Vehicles: 0.5 %: the detergent base contained sodium alkylbenzenesulphonate, sodium alkyl sulphate, sodium tripolyphosphate, sodium sulphate and minor ingredients including perfumes. Component concentrations were not listed, but were stated as being within ranges of usual commercial formulations.
- Concentration of brightener in vehicle: 10 %.
- Concentration of vehicle applied: in 0.5 % aqueous solution.
- Type of application: occlusive patches
- Applications: series of nine applications, each of 24 hours duration, during a three-week period.
- Challenge: two weeks later the TS application.

EXAMINATIONS
The application sites were graded for primary irritation at intervals during the insult patching sequence.

Results and discussion

Results of examinations:
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 65
- Number of subjects with irritating reactions: 0

The material did not appear to cause irritation. None of the subjects was sensitized.

Applicant's summary and conclusion

Conclusions:
0 sensitized/65 subjects.
The material did not appear to cause irritation. None of the subjects was sensitized.
Executive summary:

Method

The test material (at 0.5 % aqueous solution of a detergent mixture containing 10 % brightener) was applied under occlusive patches in a series of nine applications (each of 24 hours duration) during a 3 week period to 70 human . Challenge applications were made 2 weeks later.

The vehicle also was applied as a negative control. No positive control was applied. The detergent base contained sodium alkylbenzenesulfonate, sodium alkyl sulfate, sodium tripolyphosphate, sodium sulfate and minor ingredients including perfumes. Component concentrations were not listed, but were stated as being within ranges of usual commercial formulations. The test application sites were graded for primary irritation at various intervals.

Results

0 sensitized/65.

The material did not appear to cause irritation. None of the subjects was sensitized.