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Diss Factsheets

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:
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 of Oleic Acid, Laurie Acid, Palmitic Acid, Myristic Acid, and Stearic Acid
Author:
Cosmetic Ingredient Review (CIR) Panel
Year:
1987
Bibliographic source:
JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY Volume 6, Number 3, 1987.

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
A modified repeated insult patch test (RIPT) was carried out for test chemical Palmitic acid (CAS No: 57-10-3) in 52 human volunteers to determine the degree of sensitization caused by the chemical.
GLP compliance:
not specified
Type of study:
other: A modified repeated insult patch test (RIPT)
Justification for non-LLNA method:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Palmitic acid
EC Number:
200-312-9
EC Name:
Palmitic acid
Cas Number:
57-10-3
Molecular formula:
C16H32O2
IUPAC Name:
Hexadecanoic acid
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): Palmitic acid
- Molecular formula: C16H32O2
- Molecular weight: 256.4268 g/mol
- Substance type: organic
- Physical state: solid
- Smiles: C(CCCCCCCCCC)CCCCC(=O)O
- InChI: 1S/C16H32O2/c1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-16(17)18/h2-15H2,1H3,(H,17,18)
Specific details on test material used for the study:
- Name of test material (as cited in study report): Palmitic acid
- Molecular formula: C16H32O2
- Molecular weight: 256.4268 g/mol
- Substance type: organic
- Physical state: solid
- Smiles: C(CCCCCCCCCC)CCCCC(=O)O
- InChI: 1S/C16H32O2/c1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-16(17)18/h2-15H2,1H3,(H,17,18)

In vivo test system

Test animals

Species:
other: human
Strain:
other: Not applicable
Details on test animals and environmental conditions:
No data available

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, open
Vehicle:
not specified
Concentration / amount:
2.2%
Day(s)/duration:
24 hours
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
not specified
Concentration / amount:
2.2%
Day(s)/duration:
48 hours
Adequacy of challenge:
not specified
No. of animals per dose:
52
Details on study design:
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 24 hours
- Test groups: 52 subjects
- Control group: no data
- Site: no data
- Frequency of applications: 10 alternate day
- Duration: 24 hours
- Concentrations: 2.2%

B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: after 2-2 weeks
- Exposure period:48 hours
- Test groups: 52 subjects
- Control group: no data
- Site: no data
- Concentrations: 2.2%
- Evaluation (hr after challenge): after 48 hours

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
2.2%
No. with + reactions:
0
Total no. in group:
52
Clinical observations:
None of the subject had skin sensitizing reaction.
Remarks on result:
no indication of skin sensitisation

In vivo (LLNA)

Cellular proliferation data / Observations:
None of the subject had skin sensitizing reaction.

Applicant's summary and conclusion

Interpretation of results:
other: Not sensitizing
Conclusions:
The test material Palmitic acid (CAS No: 57-10-3) was considered to be not sensitizing to the skin of in 52 human volunteers in a modified repeated insult patch test (RIPT).
Executive summary:

A modified repeated insult patch test (RIPT) was carried out for test chemical Palmitic acid (CAS No: 57-10-3) in 52 human volunteers to determine the degree of sensitization caused by the chemical.

 

Each subject was induced with patch of 2.2% Palmitic acid for 10 alternate days for the exposure period of 24 hours. After 2- to 3-week non treatment phase subjects were challenged at same concentration  by means of a single 48-h challenge patch.

 

None of the 52 subjects had developed any skin sensitizing reaction. Thus the chemical Palmitic acid (CAS No: 57-10-3) was considered to be not sensitizing to the skin of in 52 human volunteers in a modified repeated insult patch test (RIPT).