Registration Dossier

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:
other: Regulation for the Enforcement of the Federal Hazardous Substances Act (Revised, Federal Register, September 17, 1964)
Deviations:
no
Qualifier:
according to
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

Reference
Name:
Unnamed
Type:
Constituent
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