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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07/07/1997 - 16/10/1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2023
Report date:
1997

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction Mass of (1S,2R,5R)-2-(2-hydroxypropan-2-yl)-5-methylcyclohexan-1-ol and (1R,2R,5R)-2-(2-hydroxypropan-2-yl)-5-methylcyclohexan-1-ol
Molecular formula:
not applicable
IUPAC Name:
Reaction Mass of (1S,2R,5R)-2-(2-hydroxypropan-2-yl)-5-methylcyclohexan-1-ol and (1R,2R,5R)-2-(2-hydroxypropan-2-yl)-5-methylcyclohexan-1-ol
Test material form:
liquid
Specific details on test material used for the study:
Clear Viscous liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: 11-12 weeks
- Weight at study initiation: 2.5 - 2.7kg
- Housing: individually in suspended stainless steel cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 65-78%
- Humidity (%): 38-81%
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod: 12 hrs light -12 hrs dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL of 100 % test substance
Duration of treatment / exposure:
once
Observation period (in vivo):
28 days
Number of animals or in vitro replicates:
9
Details on study design:
After instillation of the test article, test and control eyes of rabbits were rinsed with physiological saline. The remain rabbits were not rinsed.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Remarks:
No rinse group
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 10 days
Remarks on result:
positive indication of irritation
Remarks:
Observation over 14 days period
Irritation parameter:
chemosis score
Remarks:
No rinse group
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 10 days
Remarks on result:
positive indication of irritation
Remarks:
Observation over 14 days period
Irritation parameter:
chemosis score
Remarks:
No rinse group
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 10 days
Remarks on result:
positive indication of irritation
Remarks:
Observation over 14 days period
Irritation parameter:
chemosis score
Remarks:
No rinse group
Basis:
animal #3
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 10 days
Remarks on result:
positive indication of irritation
Remarks:
Observation over 14 days period
Irritation parameter:
chemosis score
Remarks:
No rinse group
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Remarks:
Observation over 21 days period
Irritation parameter:
chemosis score
Remarks:
No rinse group
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
Observation over 28 days period
Irritation parameter:
conjunctivae score
Remarks:
No rinse group
Basis:
animal #6
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Remarks:
Observation over 14 days period
Irritation parameter:
conjunctivae score
Remarks:
No rinse group
Basis:
animal #5
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Remarks:
Observation over 14 days period
Irritation parameter:
conjunctivae score
Remarks:
No rinse group
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Remarks:
Observation over 14 days period
Irritation parameter:
conjunctivae score
Remarks:
No rinse group
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Remarks:
Observation over 14 days period
Irritation parameter:
conjunctivae score
Remarks:
No rinse group
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
Observation over 21 days period
Irritation parameter:
conjunctivae score
Remarks:
No rinse group
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
Observation over 28 days period
Irritation parameter:
iris score
Remarks:
No rinse group
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Remarks:
Observation over 14 days period
Irritation parameter:
iris score
Remarks:
No rinse group
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Remarks:
Observation over 14 days period
Irritation parameter:
iris score
Remarks:
No rinse group
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Remarks:
Observation over 14 days period
Irritation parameter:
iris score
Remarks:
No rinse group
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Remarks:
Observation over 14 days period
Irritation parameter:
iris score
Remarks:
No rinse group
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 10 days
Remarks on result:
positive indication of irritation
Remarks:
Observation over 21 days period
Irritation parameter:
iris score
Remarks:
No rinse group
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
Observation over 28 days period
Irritation parameter:
cornea opacity score
Remarks:
No rinse group
Basis:
animal #6
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Remarks:
Observation over 14 days period
Irritation parameter:
cornea opacity score
Remarks:
No rinse group
Basis:
animal #5
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 10 days
Remarks on result:
positive indication of irritation
Remarks:
Observation over 14 days
Irritation parameter:
cornea opacity score
Remarks:
No rinse group
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 10 days
Remarks on result:
positive indication of irritation
Remarks:
Observation over 14 days period
Irritation parameter:
cornea opacity score
Remarks:
No rinse group
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 10 days
Remarks on result:
positive indication of irritation
Remarks:
Observation over 14 days period
Irritation parameter:
cornea opacity score
Remarks:
No rinse group
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 10 days
Remarks on result:
positive indication of irritation
Remarks:
Observation over 21 days period
Irritation parameter:
cornea opacity score
Remarks:
No rinse group
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
Observation over 28 days period
Irritation parameter:
chemosis score
Remarks:
Rinsed group
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 10 days
Remarks on result:
positive indication of irritation
Remarks:
Observation over 10 days period
Irritation parameter:
chemosis score
Remarks:
Rinsed group
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Remarks:
Observation over 14 days period
Irritation parameter:
chemosis score
Remarks:
Rinsed group
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 10 days
Remarks on result:
positive indication of irritation
Remarks:
Observation over 14 days period
Irritation parameter:
conjunctivae score
Remarks:
Rinsed group
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 10 days
Remarks on result:
positive indication of irritation
Remarks:
Observation over 10 days period
Irritation parameter:
conjunctivae score
Remarks:
Rinsed group
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Remarks:
Observation over 14 days period
Irritation parameter:
conjunctivae score
Remarks:
Rinsed group
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Remarks:
Observation over 14 days period
Irritation parameter:
iris score
Remarks:
Rinsed group
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Remarks:
Observation over 10 days period
Irritation parameter:
iris score
Remarks:
Rinsed group
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Remarks:
Observation over 14 days period
Irritation parameter:
iris score
Remarks:
Rinsed group
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Remarks:
Observation over 14 days period
Irritation parameter:
cornea opacity score
Remarks:
Rinsed group
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Remarks:
Observation over 10 days period
Irritation parameter:
cornea opacity score
Remarks:
Rinsed group
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Remarks:
Observation over 14 days period
Irritation parameter:
cornea opacity score
Remarks:
Rinsed group
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Remarks:
Observation over 14 days period
Other effects:
No Rinsed goup:
Noevascularization: 3/6
Corneal edema: 1/6
raised area on the cornea: 1/6

Rinsed group:
Noevascularization: 1/3

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Based on the no rinse group, the test item is considered to be a severe irritant to the ocular tissue of the rabbit. Based on the rinse group, the test substance is considered to be a moderate irritant to the ocular tissue of the rabbit.