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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 939-066-9 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Scientific Panel Review Article. Results according to OECD scoring system, but without individual scores. No data on GLP.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 1 982
Materials and methods
- Principles of method if other than guideline:
- -Principle of test: Results according to OECD scoring system. Limited data provided on the test method. An skin irritation test was performed on ammonium stearate. The test material was applied to rabbits in a single dose under occlusive conditions.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Ammonium stearate
- EC Number:
- 213-695-2
- EC Name:
- Ammonium stearate
- Cas Number:
- 1002-89-7
- Molecular formula:
- C18H36O2.H3N
- IUPAC Name:
- ammonium stearate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- Test item concentration: 100%.
Single dose. - Details on study design:
- The test material was applied in a single dose under occlusive conditions.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.62
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
The primary dermal irritation index (PDII) for ammonium stearate was determined to be 0.62.
Applicant's summary and conclusion
- Interpretation of results:
- other: No category (CLP Regulation EC no. 1272/2008)
- Conclusions:
- Ammonium stearate is non-irritant for skin (PII=0.62).
- Executive summary:
A skin irritation test was performed on ammonium stearate at a concentration of 100% on rabbits. Test material was applied in a single dose under occlusive conditions. The primary irritation index (P.I.I.) was determined to be 0.62. The substance was non-irritant for skin.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
