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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
other: Basic data given

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1976

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: Regulation for the Enforcement of the Federal Hazardous Substances Act (Revised, Federal Register, September 17, 1964)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Title 49, Department of Transportation Code of Federal Regulation, Section 173, 240 (Federal Register, February 12, 1973)
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Stearic acid
EC Number:
200-313-4
EC Name:
Stearic acid
Cas Number:
57-11-4
Molecular formula:
C18H36O2
IUPAC Name:
stearic acid
Details on test material:
- Composition of test material, percentage of components: C14: 0.2%; C16: 7.7%; C17: 0.2%; C18: 91.9%

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Duration of treatment / exposure:
single application
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: mean 27 -48- 72 h
Score:
0.2
Max. score:
3
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: effects note in 2/6 animals
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: mean 27 -48- 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects noted
Irritation parameter:
iris score
Time point:
other: mean 27 -48- 72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects noted
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: mean 27 -48- 72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects noted

Any other information on results incl. tables

Mild conjunctival erythema was shown in 2 of 6 animals at 24 and 48 hours while all signs of irritation hat subsided completely in 72 hours.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU