Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only short abstract available
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1959
Report Date:
1959

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
A human patch test was conducted to investigate the skin sensitising properties of Tween 61 at a concentration of 60%.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tween 61
- Analytical purity: no data
- Lot/batch No.: 198

Method

Type of population:
not specified
Subjects:
- Number of subjects exposed: 50
Controls:
no data
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Description of patch: absorbent cotton twill (one-inch square), sealed with elastic adhesive patch (two-inch square)
- Concentrations: 60% (aqueous solution)
- Volume applied: no data
- Testing/scoring schedule: initial application for 3 days, challenging application for 3 days (7 days after removal of initial patch)

EXAMINATIONS
- Grading/Scoring system: no data

Results and discussion

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

Applicant's summary and conclusion

Conclusions:
At the end of the 72 h exposure period no reactions on the skin in any of the subjects were observed after initial application.
At the end of the 72 h exposure period no reactions on the skin in any of the subjects were observed after challenging application. There were no delayed reactions after the first and second series of patches. This indicates that the chemical is not a sensitiser.