Registration Dossier

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: Acceptable, well documented study report. Test procedure according to national standards

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
other: FEDERAL REGISTER 38, NO. 187, PARA. 1500.42, 5. 27029; 27.09.73
Principles of method if other than guideline:
Method: Draize Test
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Citronellol
- Substance No.: 78/741

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Sex: female
- Weight at study initiation: mean 2.57 kg (2.33 - 3.15 kg)
- Diet: SSNIFF sold by Intermast

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left eye untreated, serves as control
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
application into the conjunctival sac of the lower right eyelid
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM:

turgor/swelling of conjunctiva or opacity of cornea:
0 = nonexistant
1 = slight
2 = distinct
3 = intense
4 = severe

affected area of cornea:
1 = 0 < A < 1/4
2 = 1/4 <= A < 1/2
3 = 1/2 <= A < 3/4
4 = 3/4 <= A

redness of conjunctiva:
0 = regular
1 = slightly increased
2 = distinct
3 = intense

secretion:
0 = regular
1 = slightly increased
2 = distinctly increased
3 = highly increased

iris:
1 = ciliary injection
2 = iritia

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
30.5
Max. score:
39
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0.28
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
1.72
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
1.44
Max. score:
4
Reversibility:
fully reversible within: 8 days
Other effects:
- scars in all animals
- suppuration in one animal
- pupil contraction in one animal

Any other information on results incl. tables

Results:

 cornea      iris conjunctiva     calculated irritation scores    
time animal opacity area redness turgor/swelling secretion other cornea iris conjunctiva total mean
24 h 1 1 4 0 2 2 2 scar 20 0 12 32 33,67
2 1 4 0 2 2 2 scar 20 0 12 32
3 1 4 1 2 2 2 scar 20 5 12 37
4 1 4 0 2 2 2 scar 20 0 12 32
5 1 4 1 2 2 2 scar 20 5 12 37
6 1 4 0 2 2 2 scar 20 0 12 32
48 h 1 1 4 0 1 1 1 scar 20 0 6 26 29,00
2 1 4 0 2 2 2 scar 20 0 12 32
3 1 4 1 2 2 3 scar/suppuration 20 5 14 39
4 1 4 0 2 1 1 scar 20 0 8 28
5 1 3 0 1 1 1 scar 15 0 6 21
6 1 4 0 2 1 1 scar/pupil contraction 20 0 8 28
72 h 1 1 4 0 1 1 1 scar 20 0 6 26 28,83
2 1 4 1 2 1 2 scar 20 5 10 35
3 1 4 1 2 2 3 scar/suppuration 20 5 14 39
4 1 4 0 1 0 1 scar 20 0 4 24
5 1 3 0 1 1 1 scar 15 0 6 21
6 1 4 0 2 1 1 scar/pupil contraction 20 0 8 28
8 d 1 0 0 0 0 0 0 scar 0 0 0 0 5,17
2 1 1 0 2 0 1 scar 5 0 6 11
3 0 0 0 1 0 1 scar 0 0 4 4
4 1 1 0 1 0 0 scar 5 0 2 7
5 1 1 0 1 0 0 scar 5 0 2 7
6 0 0 0 1 0 0 scar 0 0 2 2
Mean 24-72 h 1 1.0 4.0 0.0 1.3 1.3 1.3 20.0 0.0 8.0 28.0
2 1.0 4.0 0.3 2.0 1.7 2.0 20.0 1.7 11.3 33.0
3 1.0 4.0 1.0 2.0 2.0 2.7 20.0 5.0 13.3 38.3
4 1.0 4.0 0.0 1.7 1.0 1.3 20.0 0.0 8.0 28.0
5 1.0 3.3 0.3 1.3 1.3 1.3 16.7 1.7 8.0 26.3
6 1.0 4.0 0.0 2.0 1.3 1.3 20.0 0.0 9.3 29.3
Mean 24-72 h 1 3.89 0.28 1.72 1.44 1.67 19.4 1.4 9.7 30.5

24h after application of 0,1 ml of test substance:
slight opacity of complete cornea and in 2/6 cases ciliary injections; 
all animals: distinct redness and turgor/swelling of conjunctiva, increased secretion  of tears and scarred retractions at the eyelid

72h: 
redness and turgor of conjunctiva and secretion in regression

8d: 
3/6 animals show very light opacity of small areas of cornea, 
5/6  show slight redness of conjunctiva, 
2/6 show slightly increased secretion of tears, 
1/6 shows temporary suppuration, 
1/6 shows temporary  contraction of the pupil; 
all animals: irreversible scarred alterations of the eyelid
primary irritation score: 31 -> moderately irritating

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not irritating acc. to EU criteria, but irritating acc. GHS criteria due to iris-scores >= 1.