Registration Dossier
Registration Dossier
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EC number: 500-020-4 | CAS number: 9005-67-8 1 - 6.5 moles ethoxylated
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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:
- Final Report on the Safety Assessment
- Author:
- Cosmetic Ingredient Review (CIR)
- Year:
- 1 984
- Bibliographic source:
- JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY;1984
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 test was conducted on human subjects to determine the skin sensitization potential of test chemical.
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- Sorbitan monostearate, ethoxylated
- EC Number:
- 500-020-4
- EC Name:
- Sorbitan monostearate, ethoxylated
- Cas Number:
- 9005-67-8
- Molecular formula:
- C64-H126-O26 Unspecified
- IUPAC Name:
- Sorbitan monostearate, ethoxylated
- Test material form:
- solid
- Details on test material:
- Name of the test chemical: Polysorbate 60
Molecular Formula: C64H126O26
Molecular Weight: 606.8318 g/mol
Substance Type: Organic
InChI: 1S/C32H62O10/c1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-16-17-30(36)40-25-24-37-26-28(38-21-18-33)32-31(41-23-20-35)29(27-42-32)39-22-19-34/h28-29,31-35H,2-27H2,1H3/t28-,29-,31+,32-/m1/s1
-Smiles: CCCCCCCCCCCCCCCCCC(=O)OCCOC[C@H]([C@@H]1[C@H]([C@@H](CO1)OCCO)OCCO)OCCO
Constituent 1
In vivo test system
Test animals
- Species:
- other: Human
- Strain:
- other: Not applicable
- Sex:
- not specified
- 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 subjects
- Details on study design:
- - No. of exposures: 1
- Exposure period: 72 hours
- Test groups: 50 subjects
- Control group: no data
- Site: no data
- Frequency of applications: no data
- Duration: 72 hours
- Concentrations: 100% - Challenge controls:
- not specified
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 50
- Clinical observations:
- None of the treated subjects showed allergic contact sensitization.
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- The test chemical did not induce sensitization potential when tested in a Schwartz prophetic patch test. Hence the test material was considered as not sensitizing to the skin of guinea pigs.
- Executive summary:
The Schwartz prophetic patch test was conducted on human subjects to determine the skin sensitization potential of test chemical.
The undiluted (100%) test chemical was applied onto the skin of 50 subjects and observed for skin reaction for 72 hours.
None of the treated subjects showedany signs ofskin sensitizing effects.Hence the test material was considered as not sensitizing to the skin of human.
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