Registration Dossier
Registration Dossier
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EC number: 232-306-7 | CAS number: 8002-33-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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:
- 1 985
- 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 sensitization potential of test chemical under occlusive condition.
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- not specified
Test material
- 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
Constituent 1
In vivo test system
Test animals
- Species:
- other: Human
- Strain:
- other: Not applicable
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- 72 hours
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- 72 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 50 human subjects
- Details on study design:
- A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: 72 hours
- Test groups: 50
- Control group: no data
- Site: no data
- Frequency of applications: no data
- Duration: 72 hours
- Concentrations:100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: after 7 day
- Exposure period: 72 hours
- Test groups:50
- Control group: no data
- Site: no data
- Concentrations: 100%
- Evaluation (hr after challenge): after 72 hours - Challenge controls:
- Not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 50
- Clinical observations:
- Neither the first nor the second application produced irritation or sensitization in the treated subjects.
- Remarks on result:
- no indication of skin sensitisation
In vivo (LLNA)
- Cellular proliferation data / Observations:
- Neither the first nor the second application produced irritation or sensitization in the treated subjects.
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- The test chemical was considered as not sensitizing to the skin of human subjects.
- Executive summary:
The Schwartz Prophetic Patch was conducted on 50 human subjects to assess the skin sensitization 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 sensitization in the treated subjects hence the chemical was considered as not sensitizing to the human skin.
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