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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:
1983-03-01 to 1983-03-04
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Isopropylcyclohexane
EC Number:
211-792-4
EC Name:
Isopropylcyclohexane
Cas Number:
696-29-7
Molecular formula:
C9H18
IUPAC Name:
(propan-2-yl)cyclohexane
Test material form:
liquid
Details on test material:
Test substance: purity 99.8 %

Test animals / tissue source

Species:
rabbit
Strain:
other: Small white Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS: 
- Strain: Small white Russian, Chbb-SPF
- Sex: male and female
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Weight at study initiation: 2.4-2.7 kg
- Number of animals: 3 per sex
- Water: ad libitum, tab water
- Diet: K4 Diet (Ssniff, Soest); ad libitum
- Controls: untreated eye
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1 °C
- Humidity (%): 60 % +/-5 %
- Air changes (per hr): 15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark/light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
ADMINISTRATION/EXPOSURE 
- Vehicle: none,
- Unchanged test item
- Amount applied: 0.05 g undiluted
Duration of treatment / exposure:
72 hour(s)
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
3 male and 3 female rabbits
Details on study design:
Comment: eyes not rinsed
EXAMINATIONS
- Ophtalmoscopic examination: 1, 24, 48, and 72 hours after treatment
- Scoring system: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48, 72 h
Score:
0.5
Max. score:
110
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
AVERAGE SCORE
- Cornea:  x = 0.0
- Iris:    x = 0
- Conjunctivae (Redness):   x = 0.0
- Conjunctivae (Chemosis):  x = 0.0
- Overall irritation score: 0.5/110
Other effects:
no other effects described

Any other information on results incl. tables

no further remarks

Applicant's summary and conclusion

Conclusions:
Under the conditions of this study, the test item showed no irritant effect on the eyes and mucosa of male and female rabbits.
Executive summary:

To test the acute irritant effect on eyes and mucosa the test item was administered undiluted into eyes or eyelid sacs of 3 male and female rabbits. Four of six rabbits showed slight redness and exsudation only one hour after administration.

Under the conditions of this study, the test item showed no irritant effect on the eyes and mucosa of male and female rabbits.