Registration Dossier
Registration Dossier
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EC number: 209-151-9 | CAS number: 557-05-1
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:
- 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:
- 1 982
- 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:
- 2 004
- 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:
- 2 012
- Bibliographic source:
- Hazardous Chemical Databank [HSDB], U S National Library of Medicine, last updated 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- 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 substance name:
- Zinc distearate
- EC Number:
- 209-151-9
- EC Name:
- Zinc distearate
- Cas Number:
- 557-05-1
- Molecular formula:
- C18H36O2.1/2Zn
- IUPAC Name:
- zinc distearate
- 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
Constituent 1
- 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.
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