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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Cross-reference
Reason / purpose for cross-reference:
read-across: supporting information
Reference
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose for cross-reference:
read-across source
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: Determine the skin irritation potential in the human 4-h patch test.
- Short description of test conditions: Patch tests with the test material are applied to human skin for up to 4 hours.
- Parameters analysed / observed: The presence of irritation is observed at 24, 48 and 72 hours after patch removal.
GLP compliance:
not specified
Species:
other: Human
Strain:
not specified
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
yes, concurrent positive control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.2 ml
- Concentration (if solution): Not specified
Duration of treatment / exposure:
Test materials applied progressively for 15 minutes, 30 minutes, 1, 2, 3 and 4 hours. Each progressive application is at a new skin site.
Observation period:
Treatment sites assessed at 24, 48 and 72 hours after patch removal.
Number of animals:
29
Details on study design:
TEST SITE
- Type of patch: 25 mm plain Hill Top Chamber containing a Webril pad
- Site of application: Skin of the upper outer arm
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Irritant / corrosive response data:
Of the 29 skin patches applied to humans, none produced positive irritant reactions.
Interpretation of results:
study cannot be used for classification
Conclusions:
Palmitic acid was non-irritating in the human patch test.
Executive summary:

The relative irritancy of palmitic acid was assessed in a human patch test. Plain 25 mm Hill Top Chamber patches, containing a Webril pad, with 0.2 ml palmitic acid, were applied to the skin of the upper outer arm of 29 human volunteers for up to 4 hours. The patches were removed after 4 hours, and the skin reaction at each site was observed 24, 48 and 72 hours after patch removal. Of the 29 humans assessed, 0 showed positive irritancy reactions when treated with palmitic acid patch tests. Therefore, palmitic acid was considered non-irritating.

Data source

Reference
Reference Type:
publication
Title:
Determination of skin irritation potential in the human 4-h patch test
Author:
Basketter DA, York M, McFadden JP, Robinson MK
Year:
2004
Bibliographic source:
Contact Dermatitis 51:1-4

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: Determine the skin irritation potential in the human 4-h patch test.
- Short description of test conditions: Patch tests with the test material are applied to human skin for up to 4 hours.
- Parameters analysed / observed: The presence of irritation is observed at 24, 48 and 72 hours after patch removal.
GLP compliance:
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:
palmitic acid

Test animals

Species:
other: Human
Strain:
not specified

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
yes, concurrent positive control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.2 ml
- Concentration (if solution): Not specified
Duration of treatment / exposure:
Test materials applied progressively for 15 minutes, 30 minutes, 1, 2, 3 and 4 hours. Each progressive application is at a new skin site.
Observation period:
Treatment sites assessed at 24, 48 and 72 hours after patch removal.
Number of animals:
29
Details on study design:
TEST SITE
- Type of patch: 25 mm plain Hill Top Chamber containing a Webril pad
- Site of application: Skin of the upper outer arm

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Irritant / corrosive response data:
Of the 29 skin patches applied to humans, none produced positive irritant reactions.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
Palmitic acid was non-irritating in the human patch test.
Executive summary:

The relative irritancy of palmitic acid was assessed in a human patch test. Plain 25 mm Hill Top Chamber patches, containing a Webril pad, with 0.2 ml palmitic acid, were applied to the skin of the upper outer arm of 29 human volunteers for up to 4 hours. The patches were removed after 4 hours, and the skin reaction at each site was observed 24, 48 and 72 hours after patch removal. Of the 29 humans assessed, 0 showed positive irritancy reactions when treated with palmitic acid patch tests. Therefore, palmitic acid was considered non-irritating.