Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP, not a guideline study (although similar to present OECD guideline)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: H.A.R.E. Rabbits for Research, Hewitt, New Jersey
- Weight at study initiation: 2236 to 2903 grams
- Housing: The rabbits were individually housed in hanging wire-mesh cages in temperature and humidity controlled quarters.
- Diet: ad libitum
- Water: ad libitum
- acclimization period: 20 days

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the left eye served as-the untreated control for each rabbit
Amount / concentration applied:
0.1 mL of the test material
Duration of treatment / exposure:
Single treatment
Observation period (in vivo):
1, 24, 48, 72 hours and 7 days after application
Number of animals or in vitro replicates:
6 rabbits (3 males and 3 females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: not done

SCORING SYSTEM: Draize, J. H., Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Assoc. Food and Drug Officials of the U.S., Austin, Texas, 1959, page 51, Modified according to revision of 1964. Edited"by A. J. Lehman. Further modified (inclusion of-0.5 scores) at International Research and Developmen.
Corporation.

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
4
Remarks on result:
other: males and females
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
other: males and females
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
other: male
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24/48/72 h
Score:
0.8
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: male
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
other: male
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: male
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24/48/72 h
Score:
0.17
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: male
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: male
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24/48/72 h
Score:
0.8
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: female
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24/48/72 h
Score:
0.17
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: female
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24/48/72 h
Score:
0.17
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: female
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24/48/72 h
Score:
0.17
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: female
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: female
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: female

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance examined in this study, 65 % 1,1-Di (t-butyl peroxy) cyclohexane, was considered not to be irritating to the eyes.
Executive summary:

The test substance, 65 % 1,1-Di (t-butyl peroxy) cyclohexane was examined for its eye irritation potential in 6 New Zealand White rabbits. The rabbits were administered with 0.1 mL of the test substance, placed into the cupped conjunctival sac of the right eye of each rabbit while the left eye served as-the untreated control for each rabbit. The eyes were not washed and observations/ scoring with sodium fluorescein solution were performed at 24, 48, 72 hours and 7 days after application. Results were scored by modified Draize scoring method (scoring with 0.5 intervals), showing according to the grading used in the study, regulations of the Federal Hazardous Substances Act., (and in accordance with present regulation, OECD GHS) that the test material is not be considered a primary eye-irritant.