Registration Dossier
Registration Dossier
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EC number: 208-031-3 | CAS number: 506-30-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
Data source
Referenceopen allclose all
- Reference Type:
- other: study report
- Title:
- Skin sensitisation data for 57-10-3
- Author:
- Cosmetic Ingredient Review
- Year:
- 2 005
- Bibliographic source:
- Cosmetic Ingredient Review; Final Report of the Cosmetic Ingredient Review Expert Panel; Final Report on the Safety Assessment of Oleic Acid, Lauric Acid, Palmitic Acid, Myristic Acid, and Stearic Acid; p. 53, June 2005.
- Reference Type:
- other: Authoritative data base
- Title:
- HSDB number : 5001
- Author:
- HSDB Database
- Year:
- 2 011
- Bibliographic source:
- HSDB (Cosmetic Ingredient Review; Final Report of the Cosmetic Ingredient Review Expert Panel; Final Report on the Safety Assessment of Oleic Acid, Lauric Acid, Palmitic Acid, Myristic Acid, and Stearic Acid; p. 53, June 2005.)
Materials and methods
- Principles of method if other than guideline:
- Standard Schwartz-Peck procedure.
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- Palmatic acid
- IUPAC Name:
- Palmatic acid
- Reference substance name:
- Palmitic acid
- EC Number:
- 200-312-9
- EC Name:
- Palmitic acid
- Cas Number:
- 57-10-3
- IUPAC Name:
- palmitic acid
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report):Palmitic acid
- Molecular formula (if other than submission substance):C16H32O2
- Substance type:Organic
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- human
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: closed and open patches
- Vehicle:
- no data
- Concentration / amount:
- A shave cream formulation containing 2.2% Palmitic Acid
Challengeopen allclose all
- Route:
- other: skin
- Vehicle:
- no data
- Concentration / amount:
- A shave cream formulation containing 2.2% Palmitic Acid
- No. of animals per dose:
- 101 human
- Details on study design:
- INDUCTION EXPOSURE
- No. of exposures:Two
- Exposure period:24-hr
- Site:Closed and open
- Duration:10-14 days
- Concentrations:2.2% - Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 2.2%
- No. with + reactions:
- 3
- Total no. in group:
- 101
- Clinical observations:
- There were 3 reactions of mild to intense erythema to the closed challenge patch and the formulation was considered " nonsensitizing ".
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. Group: test group. Dose level: 2.2%. No with. + reactions: 3.0. Total no. in groups: 101.0. Clinical observations: There were 3 reactions of mild to intense erythema to the closed challenge patch and the formulation was considered " nonsensitizing "..
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a prophetic patch test, a shave cream formulation containing 2.2% Palmitic Acid was tested for sensitization of the skin of 101 human subjects. Two 24-hr closed and open patches are usually applied to the skin 10-14 days apart in the standard Schwartz-Peck procedure. There were 3 reactions of mild to intense erythema to the closed challenge patch and the formulation was considered " nonsensitizing."
- Executive summary:
In a prophetic patch test, a shave cream formulation containing 2.2% Palmitic Acid was tested for sensitization of the skin of 101 human subjects. Two 24-hr closed and open patches are usually applied to the skin 10-14 days apart in the standard Schwartz-Peck procedure. There were 3 reactions of mild to intense erythema to the closed challenge patch and the formulation was considered " nonsensitizing."
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