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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:
weight of evidence
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 journal.

Data source

Reference
Reference Type:
publication
Title:
Final Report on the Safety Assessment of Oleic Acid, Laurie Acid, Palmitic Acid, Myristic Acid, and Stearic Acid
Author:
Cosmetic Ingredient Review (CIR) Panel
Year:
1987
Bibliographic source:
JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY Volume 6, Number 3, 1987.

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
A Draize study was conducted to assess the eye irritation potential of test chemical Stearic acid (CAS No: 57-11-4) in six New Zealand white rabbits.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Octadecanoic acid
Cas Number:
57-11-4
Molecular formula:
C18H36O2
IUPAC Name:
Octadecanoic acid
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): Stearic acid
- Molecular formula: C18H36O2
- Molecular weight: 284.4804 g/mol
- Smiles notation: C(CCCCCCCCCCC)CCCCCC(=O)O
- InChl: 1S/C18H36O2/c1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-16-17-18(19)20/h2-17H2,1H3,(H,19,20)
- Substance type: organic
- Physical state: solid
Specific details on test material used for the study:
- Name of test material (as cited in study report): Stearic acid
- Molecular formula: C18H36O2
- Molecular weight: 284.4804 g/mol
- Smiles notation: C(CCCCCCCCCCC)CCCCCC(=O)O
- InChl: 1S/C18H36O2/c1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-16-17-18(19)20/h2-17H2,1H3,(H,19,20)
- Substance type: organic
- Physical state: solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
No data available

Test system

Vehicle:
other: Ethylene oxide
Controls:
not specified
Amount / concentration applied:
65%
Duration of treatment / exposure:
No Data Available
Observation period (in vivo):
No Data Available
Duration of post- treatment incubation (in vitro):
No Data Available
Number of animals or in vitro replicates:
6
Details on study design:
No Data Available

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No known signs of ocular were observed.

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Conclusions:
The test material Stearic acid (CAS No: 57-11-4) was considered to be not irritating to the eye of New Zealand white rabbits.
Executive summary:

A Draize study was conducted to assess the eye irritation potential of test chemical Stearic acid (CAS No: 57-11-4) in six New Zealand white rabbits.

 

The chemical was installed into the eye of each animal at concentration of 65% in ethylene oxide and then observed for ocular lesions.

 

No known signs of irritation were observed in treated animals. Hence the chemicalStearic acid (CAS No: 57-11-4)was considered to be not irritating to the eye ofNew Zealand white rabbits.