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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: The procedure adopted was the technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).
Deviations:
not specified
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
None

Test animals / tissue source

Species:
rabbit
Strain:
other: Russian breed
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Housing: V2A wire cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 g of the test substance
Duration of treatment / exposure:
One application
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6 rabbits (3 males and 3 females)
Details on study design:
Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. After application, the eyelids were held open for a few seconds. The right eye served as a control. The treated eyes of three rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment.

The reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days on the basis of the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO.

SCORING SYSTEM:
Cornea
A. Opacity-degree of density (area most dense taken for reading)
- 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
Total maximum = 80 (A x B x 5)

Iris
A. Values
- Normal: 0
- Folds above normal, congestion, swelling, circumcorneal 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
A x 5

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 adjacent to lids: 2
- Discharge with moistening of the lids and hairs, and considerable area around the eye: 3
(A + B + C) x 2 Total maximum = 20

The total maximum is 80 for the cornea, 10 for the iris and 20 for the conjunctivae.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 females (eyes rinsed)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Remarks:
eyes not rinsed
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not specified
Irritation parameter:
cornea opacity score
Basis:
animal #5
Remarks:
eyes not rinsed
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
cornea opacity score
Basis:
animal #6
Remarks:
eyes not rinsed
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
eyes rinsed
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 72h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
eyes rinsed
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 72h
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
eyes rinsed
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 72h
Irritation parameter:
conjunctivae score
Basis:
animal #4
Remarks:
eyes not rinsed
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
not fully reversible within: 7d
Irritation parameter:
conjunctivae score
Basis:
animal #5
Remarks:
eyes not rinsed
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 7d
Irritation parameter:
conjunctivae score
Basis:
animal #6
Remarks:
eyes not rinsed
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 7d
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
eyes rinsed
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
eyes rinsed
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
eyes rinsed
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
animal #4
Remarks:
eyes not rinsed
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
not fully reversible within: 7d
Irritation parameter:
chemosis score
Basis:
animal #5
Remarks:
eyes not rinsed
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
fully reversible within: 7d
Irritation parameter:
chemosis score
Basis:
animal #6
Remarks:
eyes not rinsed
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
fully reversible within: 7d
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 female eyes rinsed and 3 female eyes not rinsed
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The results of the eye irritation test are summarized in tables 1 and 2. The total maximum is 80 for the cornea, 10 for the iris and 20 for the conjunctivae. The irritation index was found to be 10.8 for the cornea, 0 for the iris and 6.9 for the conjunctivae.

Any other information on results incl. tables

Eyes rinsed:

Days after application Rabbit 1 Female Rabbit 2 Female Rabbit 3 Female
Cornea Iris Conjuct. Cornea Iris Conjuct. Cornea Iris Conjuct.
1 0 0 10 0 0 10 0 0 12
2 0 0 6 0 0 10 0 0 10
3 0 0 0 0 0 0 0 0 0
4 0 0 0 0 0 0 0 0 0
7 0 0 0 0 0 0 0 0 0

Eyes not rinsed:

Days after application Rabbit 4 Male Rabbit 5 Male Rabbit 6 Male
Cornea Iris Conjuct. Cornea Iris Conjuct. Cornea Iris Conjuct.
1 20 0 18 10 0 16 30 0 18
2 30 0 12 5 0 12 45 0 12
3 40 0 12 0 0 10 45 0 10
4 30 0 8 0 0 6 40 0 6
7 20 0 8 0 0 0 10 0 0

Data represent values of calculated primary eye irritation index. Eyes not rinsed should not be taken into account for the overall hazard assessment.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 40069/A is to be considered as a non-irritant to the eye of rabbits.
Executive summary:

A study was performed to determine the eye irritation potential of FAT 40069/A on rabbits according to the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). The substance was tested on 6 rabbits (3 males/3 females) of the Russian breed and only rabbits showing normal ophthalmic findings were included in the test. Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. After application, the eyelids were held open for a few seconds. The right eye served as a control. The treated eyes of three rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment. The reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days. The primary-irritation index, which serves as a measure of the acute irritation provoked by the substance, was found to be 10.8 for the cornea, 0 for the iris and 6 .9 for the conjunctivae. The effects were observed to be completely reversible by the end of Day 7. FAT 40069/A is to be considered as a non-irritant to the eye of rabbits.