Registration Dossier
Registration Dossier
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EC number: 206-101-8 | CAS number: 300-92-5
Eye irritation
Administrative data
- Endpoint:
- eye 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:
- Draize study was conduted to evaluate the eye irritation potential of Aluminium distearate
- GLP compliance:
- no
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 / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- No data
Test system
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- 10% suspension
- Duration of treatment / exposure:
- No data available
- Observation period (in vivo):
- 24, 48, 72 hrs
- Number of animals or in vitro replicates:
- No data available
- Details on study design:
- No data available
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48
- Reversibility:
- fully reversible within: 72 hrs
- Remarks on result:
- other: Scores 1 , 1, and 0 on Days 1 , 2, and 3, respectively
- 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:
- Aluminum stearate was found to be minimal irritating with the score of 1, 1, and 0 on day 1, 2 , and 3.
- Executive summary:
Eye irritation study was conducted on rabbits to evaluate the eye irritation potential of the test compound Aluminium distearate according to Draize method.
10 % suspension in corn oil was instilled into the eyes.Eyes were unrinsed . Scores 1 , 1, and 0 on Days 1 , 2, and 3, respectively.
Aluminum distearate was found to be minimal irritating to the eyes of rabbits.
As per the publication, the test material classifies as an eye irritant.
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