Registration Dossier
Registration Dossier
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EC number: 943-428-1 | CAS number: -
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 for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 959
- 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 substance name:
- Tween 61
- IUPAC Name:
- Tween 61
- Details on test material:
- - Name of test material (as cited in study report): Tween 61
- Analytical purity: no data
- Lot/batch No.: 198
Constituent 1
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.
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