Registration Dossier
Registration Dossier
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EC number: 943-428-1 | CAS number: -
Sensitisation data (human)
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 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 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 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
- 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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