Registration Dossier

Toxicological information

Exposure related observations in humans: other data

Administrative data

Endpoint:
exposure-related observations in humans: other data
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 study / information:
Human Patch tests were performed on 50 subjects to determine primary irritation and sensitisation of the test substance at a concentration of 60%.
Endpoint addressed:
skin irritation / corrosion
Principles of method if other than guideline:
A human patch test was conducted to investigate the skin irritating and sensitising properties of Tween 61 at a concentration of 60%.
GLP compliance:
not specified

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

Details on study design:
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)

Details on exposure:
TYPE OF EXPOSURE: epicutaneous, occlusive

EXPOSURE LEVELS: 60% (aqueous solution)

EXPOSURE PERIOD: initial exposure: 3 days; challenge exposure: 3 days (7 days after removal of initial patch)

POSTEXPOSURE PERIOD: 7 days after initial 3-day exposure

DESCRIPTION OF EXPOSURE GROUPS:
- Number of subjects exposed: 50

Results and discussion

Results:
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. This shows that the chemical is not a primary skin irritant.