Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
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:
Acute dermal toxicity test was performed in rats at 100% concentration of aluminum distearate
GLP compliance:
no
Test type:
other: No data available

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No data available

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data available

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
No data available
Duration of exposure:
No data available
Doses:
100%
No. of animals per sex per dose:
No data available
Control animals:
not specified
Details on study design:
No data available
Statistics:
No data available

Results and discussion

Preliminary study:
No data available
Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No data available
Clinical signs:
No data available
Body weight:
No data available
Gross pathology:
No data available
Other findings:
No data available

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD 50 value for Aluminum distearate (300-92-5) was found to be >5000mg/kg.
Executive summary:

Acute dermal toxicity test was performed in rats at 100% concentration of aluminum distearate. After experiment it was observed that the LD 50 value for Aluminum distearate (300-92-5) was found to be >5000mg/kg.