Registration Dossier
Registration Dossier
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EC number: 247-569-3 | CAS number: 26266-58-0
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
- Study period:
- 1959
- 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 test
- Endpoint addressed:
- skin irritation / corrosion
- Principles of method if other than guideline:
- human patch test
- GLP compliance:
- no
Test material
- Reference substance name:
- Anhydro-D-glucitol trioleate
- EC Number:
- 247-569-3
- EC Name:
- Anhydro-D-glucitol trioleate
- Cas Number:
- 26266-58-0
- Molecular formula:
- C60H108O8
- IUPAC Name:
- 1,4-anhydro-2,3,6-tri-O-oleoyl-L-iditol
- Details on test material:
- - Name of test material (as cited in study report): Only trade name given
- Analytical purity: no data
- Lot/batch No.: 201
Constituent 1
Method
- Details on study design:
- - Number of subjects exposed: 50
TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Description of patch: absorbent cotton twill (one-inch square), sealed wit elastic adhesive patch (two-inch square)
- Concentrations: undiluted
- 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:
- patch test with human volunteers,
test material applied undiluted
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 in the initial application there were no reactions on the skin of any of the subjects. This shows that the chemical is not a primary skin irritant.
At the end of the 72 h exposure period in the challenging application there were no reactions on the skin of any of the subjects. There were no delayed reactions after the first and second series of patches. This indicates that the chemical is not a sensitizer.
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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