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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965)
Deviations:
not specified
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
(clinical observations for systemic effects were not done)
GLP compliance:
no
Remarks:
(Pre-GLP study)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Specific details on test material used for the study:
Name: FAT 40075/A
Purity: 74.5 %

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Bred on the premises of the testing laboratory
- Age at study initiation: 3 to 4 months
- Weight at study initiation: Males: 2.33 kg; Females: 2.06 kg
- Housing: Caged singly
- Diet: A commercial irradiated diet (Styles-Oxoid), ad libitum
- Water: Sterile filtered water, ad libitum
- Acclimation period: One week

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 1 °C
- Humidity: 50-70 %
- Photoperiod: Animals were exposed to artificial light for 10 h daily from 08: 00 - 18:00 h

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated right eye
Amount / concentration applied:
- Amount(s) applied: 100 mg
Duration of treatment / exposure:
Unwashed eye: unspecified (not rinsed after single instillation)
Washed eye: 30 sec
Observation period (in vivo):
1, 6, 24, 48 and 72 h.
Number of animals or in vitro replicates:
Six animals (four males and two females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
After 30 seconds the test substance was, as far as possible, flushed out of the eyes of three rabbits with warm water for 1 min.

SCORING SYSTEM: The primary eye irritation index represents the sum of the mean values for cornea, iris and conjunctivae.

CORNEA:
A Opacity and degree of density (most dense area scored)
No opacity 0
Scattered or diffuse area, details of iris clearly visible 1
Easily discernible translucent areas, details of iris slightly obscured 2
Opalescent areas, no details of iris visible, size of pupil barely discernible 3
Opaque, iris invisible 4

B Area of cornea involved
One quarter (or less) but not zero 1
Greater than one quarter, but less than half 2
Greater than half, but less than three quarters 3
Greater than three quarters, up to whole area 4

IRIS:
A Values
Normal 0
Folds above normal, congestion, swelling, circumcornea injection (any or all of these or combination of any thereof)
iris still reacting to light (sluggish reaction is positive) 1
No reaction to light, hemorrhage, gross destruction (any or all of these) 2

CONJUNCTIVAE :
A Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Vessels normal 0
Vessels definitely injected above normal 1
More diffuse, deeper crimson red, individual vessels not easily discernible 2
Diffuse beefy red 3

B Chemosis
No swelling 0
Any swelling above normal (includes nictitating membrane) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids about half closed to completely closed 4

C Discharge
No discharge 0
Any amount different from normal (does not include small amounts observed in inner canthus of normal animals) 1
Discharge with moistening of the lids and hairs just adj acent to lids 2
Discharge with moistening of the lids and hairs, and considerable area around the eye 3
(A + B + C) x 2 Maximum possible score = 20

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 10 d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 6 d
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 6 d
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 6 d
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 6 d
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 10
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Basis:
animal: #3, 5 and 6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: Test substance was washed 30 sec post application
Irritation parameter:
iris score
Basis:
animal: #3, 5 and 6
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
other: Test substance was washed 30 sec post application
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 6 d
Remarks on result:
other: Test substance was washed 30 sec post application
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: Test substance was washed 30 sec post application
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 6 d
Remarks on result:
other: Test substance was washed 30 sec post application
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: Test substance was washed 30 sec post application
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 6 d
Remarks on result:
other: Test substance was washed 30 sec post application
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: Test substance was washed 30 sec post application
Irritant / corrosive response data:
A moderate conjunctival reaction was seen in all animals 1 h after application of the test substance. All conjunctivae were normal by Day 10.
A corneal reaction consisting mainly of small areas of opacity and damage to the corneal epithelium was present from 1 h after application of the test substance in 3/6 animals (all unwashed eyes) and in 1/6 (washed eye) from 6 h. In three animals these changes has resolved by Day 2 but in one case changes were present until Day 6 (unwashed eye).

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the test substance was considered to be a non-irritant to rabbit eye.
Executive summary:

A study was conducted to assess the eye irritancy potential of the test substance (at ca. 74.5 % purity) in rabbits according to U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965) which is equivalent to OECD Guideline 405 with deviations. A single dose of 100 mg of test substance was applied into the lower everted lid of one eye of each animal. The eyelids were then gently held together for one second before releasing. The untreated eye served as control. The eyes of three animals were rinsed with warm water for 1 minutes after 30 seconds of test substance instillation. Both with (3/6) and without (3/6) washing, ocular reactions were scored at 1, 6, 24, 48 and 72 h and 6 and 10 d post-instillation. Instillation of the test substance elicited conjunctival redness of a mean score of 2 in 2/3 eyes (unwashed) and had resolved within 10 d after instillation. Unwashed eyes (Day 10) returned to normal later than washed (Day 6). Corneal opacity and chemosis was reversible within 72h. All the scores for Iritis were zero. Conjuctival redness was reversed within 6 days. Under the study conditions, the test substance was considered to be a non-irritant to rabbit eye.