Registration Dossier

Diss Factsheets

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:
1982
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

Constituent 1
Chemical structure
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

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.