Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: - | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Final Report on the Safety Assessment of Oleic Acid, Lauric Acid, Palmitic Acid, Myristic Acid, and Stearic Acid
- Author:
- Unknown
- Year:
- 2 005
- Bibliographic source:
- Journal of the American College of Toxicology
Materials and methods
Test guideline
- Guideline:
- other: information not available
- Principles of method if other than guideline:
- Standard Schwartz-Peck procedure
- GLP compliance:
- not specified
- Remarks:
- information not available
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:
- hexadecanoic acid
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- other: human
Test system
- Type of coverage:
- other: closed and open patches
- Vehicle:
- not specified
- Amount / concentration applied:
- formulation of 2.2% palmitic acid
- Duration of treatment / exposure:
- Application to the skin 10-14 days apart in the standard Schwartz-Peck procedure
- Number of animals:
- 101 human subjects
- Details on study design:
- Two 24-hr closed and open patches are applied to the skin 10-14 days apart in the standard Schwartz-Peck procedure
Results and discussion
In vivo
Results
- Irritation parameter:
- other: information not available
- Remarks on result:
- no indication of irritation
- Remarks:
- 3 reactions of mild to intense erythema to the closed challenge patch and the formulation was considered non irritating and non sensitizing
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- There were 3 reactions of mild to intense erythema to the closed challenge patch and the formulation was considered non irritating and non sensitizing
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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