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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:
disregarded due to major methodological deficiencies
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:
1959
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

Constituent 1
Chemical structure
Reference substance name:
Sorbitan monolaurate, ethoxylated
EC Number:
500-018-3
EC Name:
Sorbitan monolaurate, ethoxylated
Cas Number:
9005-64-5
Molecular formula:
Molecular formula cannot be given as substance is a mixture.
IUPAC Name:
Sorbitan monolaurate, ethoxylated
Details on test material:
- Name of test material (as cited in study report): Only trade name given
- Analytical purity: no data
- Lot/batch No.: 4604B

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.