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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from peer reviewed journal

Data source

Reference
Reference Type:
publication
Title:
3 Final Report on the Safety Assessment of test chemical.
Author:
Cosmetic Ingredient Review
Year:
1985
Bibliographic source:
International Journal of Toxicology

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
The Schwartz Prophetic Patch was conducted on 50 human subjects to assess the skin irritation potential of test chemical under occlusive condition.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Sorbitan, (Z)-9-octadecenoate (2:3)
EC Number:
232-360-1
EC Name:
Sorbitan, (Z)-9-octadecenoate (2:3)
Cas Number:
8007-43-0
Molecular formula:
C126H228O21
IUPAC Name:
Sorbitan sesquioleate
Details on test material:
- IUPAC Name: Sorbitan sesquioleate
- InChI: 1S/3C18H34O2.2C6H14O6/c3*1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-16-17-18(19)20;2*7-1-3(9)5(11)6(12)4(10)2-8/h3*9-10H,2-8,11-17H2,1H3,(H,19,20);2*3-12H,
1-2H2/b3*10-9-;;/t;;;2*3-,4+,5-,6-/m...11/s1
- Smiles: CCCCCCCC/C=C\CCCCCCCC(=O)O.CCCCCCCC /C=C\ CCCCCCCC(=O)O.CCCCCCCC/C=C\ CCCCCCCC (=O)O.C(O)[C@@H](O)[C@@H] (O)[C@H](O) [C@@H](O)CO.C(O) [C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)CO
- Molecular formula :C126H228O21
- Molecular weight :1211.735 g/mole
- Substance type:Organic

Test system

Type of coverage:
other: Human
Preparation of test site:
other: Not applicable
Controls:
not specified
Amount / concentration applied:
100%
Duration of treatment / exposure:
72 hours
Observation period:
72 hours
Number of animals:
50 subjects
Details on study design:
The material was applied under occlusion for 72 hours. The occlusion was then removed and the skin site evaluated. Seven days later, the material was reapplied under occlusion for 72 hours. The patch was removed, and the site was evaluated.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Neither the first nor the second application produced irritation in the treated subjects.

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Conclusions:
The test chemical was considered as not irritating to the skin of human subjects.
Executive summary:

The Schwartz Prophetic Patch was conducted on 50 human subjects to assess the skin irritation potential of test chemical under occlusive condition.

 

The material was applied under occlusion for 72 hours. The occlusion was then removed and the skin site evaluated. Seven days later, the material was reapplied under occlusion for 72 hours. The patch was removed, and the site was evaluated.

 

Neither the first nor the second application produced irritation in the treated subjects hence the chemical was considered as not sensitizing to the human skin.