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:
disregarded due to major methodological deficiencies
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only summary of the results available

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Type of study / information:
Skin irritating potential in humans
Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test substance was applied as supplied under occlusive patch during 24 h, on the upper back of 12 volunteers.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): dipentaerythrityl hexahydroxystearate
- Analytical purity: no data
- Lot/batch No.: 1603N

Method

Ethical approval:
not specified
Details on study design:
no data

Results and discussion

Results:
No skin reaction was observed in any of the subjects.
Primary skin irritation index = 0.0

Applicant's summary and conclusion

Conclusions:
Not irritating