Registration Dossier
Registration Dossier
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EC number: 206-101-8 | CAS number: 300-92-5
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:
- other: Data is from peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Final Report of the Safety Assessment of Lithium Stearate, Aluminum Distearate Aluminum Stearate, Aluminum Tristearate, Ammonium Stearate, Calcium Stearate, Magnesium Stearate, Potassium Stearate, Sodium Stearate, and Zinc Stearate
- Author:
- SAGE, American College of Toxicology
- Year:
- 1 982
- Bibliographic source:
- International Journal of Toxicology 1982 1: 143
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as per mentioned below
- Principles of method if other than guideline:
- Skin irritation study was conducted to study the effects of Aluminum distearate on rabbits.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Hydroxyaluminium distearate
- EC Number:
- 206-101-8
- EC Name:
- Hydroxyaluminium distearate
- Cas Number:
- 300-92-5
- Molecular formula:
- C36H71AlO5
- IUPAC Name:
- hydroxyaluminium distearate
- Details on test material:
- - Name of test material: Hydroxyaluminium distearate
- Molecular formula: C36H71AlO5
- Molecular weight: 610.92 g/mol
- Substance type: Organic
- Physical state: Solid
- SMILES : O=C(O[Al](OC(=O)CCCCCCCCCCCCCCCCC)O)CCCCCCCCCCCCCCCCC
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
No data available
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- other: Corn oil
- Controls:
- not specified
- Amount / concentration applied:
- 10% suspension
- Duration of treatment / exposure:
- No data available
- Observation period:
- No data available
- Number of animals:
- No data available
- Details on study design:
- No data available
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Score:
- 0.06
- Max. score:
- 8
- Reversibility:
- no data
- Remarks on result:
- other: other details not known
- Irritant / corrosive response data:
- No data available
- Other effects:
- No data available
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Minimal irritation n is observed in rabbits after exposure to aluminium disterate.
- Executive summary:
Skin irritation study is conducted in rabbits to study the effects of aluminium disterate.Material applied in a single dose under occlusive conditions. PII = 0.06 (max. = 8)
The primary irritation score was found to be 0.06 and the maximum score was 8.
Minimal irritation is observed in rabbits after exposure to aluminium disterate
As per the publication, the test material classifies as a skin irritant.
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