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Registration Dossier
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EC number: 947-787-5 | CAS number: -
Skin irritation / corrosion
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:
- 2 004
- 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
- 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
Constituent 1
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.
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