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Toxicological information

Skin sensitisation

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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:
2005
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:
2011
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
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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

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 group
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."