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Toxicological information

Eye irritation

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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:
data from handbook or collection of data
Justification for type of information:
data is from peer reviewed journals

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Final Report of the Safety Assessment of Lithium Stearate, Aluminium Distearate, Aluminium Stearate, Aluminum Tristearate, Ammonium Stearate, Calcium Stearate, Magnesium Stearate, Potassium Stearate, Sodium Stearate, and Zinc Stearate
Author:
Cosmetic Ingredient Review Expert Panel
Year:
1982
Bibliographic source:
International Journal of Toxicology 1982 1: 143
Reference Type:
secondary source
Title:
European Union Risk Assessment Report- ZINC DISTEARATE
Author:
European Chemicals Bureau
Year:
2004
Bibliographic source:
European Union Risk Assessment Report, European Chemicals Bureau, 2004
Reference Type:
other: Authoritative database
Title:
HSDB for the CAS: 557-05-1
Author:
U S National Library of Medicine
Year:
2012
Bibliographic source:
Hazardous Chemical Databank [HSDB], U S National Library of Medicine, last updated 2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Draize method
Principles of method if other than guideline:
To evaluate the ocular irritation potential of the test chemical according to Draize method
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material : zinc distearate
- Molecular Formula:C36H70O4.Zn
- Molecular Weight:632.22 g/mol
- Substance type: Organic
- Physical state: Solid
Specific details on test material used for the study:
- Name of test material: zinc distearate
- Molecular Formula: C36H70O4.Zn
- Molecular Weight: 632.22 g/mol
- Substance type: Organic
- Physical state: Solid

Test animals / tissue source

Species:
rabbit
Strain:
other: Albino
Details on test animals or tissues and environmental conditions:
no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
100 %
Duration of treatment / exposure:
3 days
Observation period (in vivo):
3 days
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
6
Details on study design:
Details on washing:
The eyes were unwashed throughout the study

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No signs of irritation observed.The overall irritation score of the test chemical was 0 on Days 1, 2, and 3,respectively

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Conclusions:
The overall irritation score of the test chemical was 0 on Days 1, 2, and 3,respectively. Bases on the overall irritation score after 3 days, Zinc stearate can be considered not irritating to eyes.
Executive summary:

A study was conducted to evaluate the ocular irritation potential of the test chemical according to Draize method. 6 albino rabbits were used for the study. Undiluted test chemical was instilled into the eyes of rabbits and the eyes remained unwashed.The reactions observed were scored after 1,2,3 days according to Draize method.

The overall irritation score of the test chemical was 0 on Days 1, 2, and 3,respectively. Bases on the overall irritation score after 3 days, Zinc stearate can be considered not irritating to eyes.