Registration Dossier

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:
1964-05-06 - 1964-08-10
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1964
Report Date:
1964

Materials and methods

Principles of method if other than guideline:
Method: Draize Test based on the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", FDA (1959)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
other TS: Origin: Esso Research and Engineering Company, 6 May 1964

Test animals / tissue source

Species:
rabbit
Strain:
other: albino rabbits
Details on test animals or tissues and environmental conditions:
TEST ANIMALS: 
- Sex: male/female
- Weight at study initiation: 2.2-2.7 kg
- Number of animals: 6 per dose group and sex
- Controls: untreated eye

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: identical animals, untreated eyes
Amount / concentration applied:
undiluted
Amount applied: 0.1 ml
Duration of treatment / exposure:
not rinsed, no removal of test substance
Observation period (in vivo):
ADMINISTRATION/EXPOSURE 
- Vehicle: undiluted into conjunctival sac of left eye, closed for 30  seconds
- Postexposure period:   1, 4, 24 hours; 2, 3, 4, 7, 10, 14 days
Number of animals or in vitro replicates:
6 albino rabbits of either sex
Details on study design:
EXAMINATIONS
- Scoring system: Draize, 1959;
- Tool used to assess score: sodium fluorescein /UV light / visual inspections

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
26
Max. score:
110
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: see below (other effects)
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.9
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: see: other effects
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.17
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: see: other effects
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
2.06
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: see: other effects
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1.06
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: see: other effects
Irritant / corrosive response data:
AVERAGE Score (6 animals)
- Cornea: 0.9
- Iris: 0.17
- Conjunctivae (Redness): 2.06
- Conjunctivae (Chemosis): 1.06
- Overall irritation score: 26
Other effects:
Immediately following application of the test material, all of the animals exhibited scrambling and preening; phonation was noted in one animal.
Irritation was moderate to severe and generally consisted of moderate or marked erythema, chemosis, and discharge, slight corneal opacity, and  
apparent corneal sloughing. One animal showed slight, transient iritis.  
The sodium fluorescein examination on the seventh day confirmed the presence of corneal lesions in two animals; re-examination at 14 days
revealed no corneal damage.

Any other information on results incl. tables

no remarks

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Draize
Conclusions:
Under the present conditions of the study, isophorone is moderately irritating to eyes of 6 albino rabbits. In this study marked irritation was observedwhich reversed within 14 days, but was still present after 7 days.
Executive summary:

The acute eye irritation properties of isophorone were estimated in a Draize test. An amount of 0.1 ml of the undiluted test substance was instilled into the left eye of each of six albino rabbits of either sex, and the untreated right eye served as control. The eyes remained unrinsed and there was no removal of test substance. The animals were observed for 14 days after application. Eye irritation index was assessed using Draize scale.

The test was evaluated as follows (average of evaluation at 24, 48 and 72 hours respectively): cornea: 0.89, iris: 0.17, conjunctivae: redness: 2.06 and chemosis: 1.06 (mean scores on Draize scale). Therefore, isophorone is considered to be moderately irritating to eyes with an overall irritation index of 26 (26 - 56 = moderately irritating).