Registration Dossier

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:
1982
Bibliographic source:
International Journal of Toxicology 1982 1: 143

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
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

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.