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Toxicological information

Skin irritation / corrosion

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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.