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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:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: "Code of Federal Regulations", Title 16, Section 1500.42
Principles of method if other than guideline:
100 mg of the test item were introduced into the right eye of six rabbits; the left eye served as a control. Evaluations were made by comparison with the control eye. The readings were made 1, 24, 48 hours and 4 and 7 days after the administration of the test substance.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Acid Red 042
IUPAC Name:
Acid Red 042
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.5 kg
- Housing: The rabbits are kept either in individual cages measuring 540 x 350 x 315 mm. or in restraining devices.
- Diet: 200 g of food is provided per animal per day in the form of granules (Granulés Lapin "entretien" SANDERS)
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 20 %
- Air changes: 12 air change per hour


Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 100 mg
Duration of treatment / exposure:
Single injection
Observation period (in vivo):
1, 24, 48, 72 hours and 4 and 7 days
Number of animals or in vitro replicates:
Six rabbits
Details on study design:
SCORING SYSTEM
CORNEA
-Opacity: degree of density (area most dense taken for reading)
No opacity. Neighter loss of brilliance nor gloss: 0
Opacity scattered or diffuse, details of iris clearly visible: 1
Translucent zone easily discernable, details of iris slight obscured: 2
Opalescent zone, no details of iris visible, size of pupil barely discernable: 3
Cornea completely opaque, iris invisible: 4
-Area of cornea affected
No ulceration or opacity: 0
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
No anomaly: 0
Iris clearly more folded than normal, congestion , swelling, circumcorneal injection (any one or all of these), iris still reacting to light (sluggish reaction is positive): 1
No reaction to light, haemorrhage ; gross destruction (any one or all of these): 2
CONJUNCTIVAE
-Redness: (refers to palpebral and bulbar conjunctivae, excluding cornea and iris).
Blood vessels normal 0
Some blood vessels definitely hyperaemic (injected): 1
Diffuse, crimson colour, individual vessels not easily discernible: 2
Diffuse beefy red: 3
-Chemosis: lids and/or nictating membrane
No swelling: 0
Slight swelling (includes nictating membrana): 1
Obvious swelling with partial eversion of lids: 2
Swelling with lids about half closed: 3
Swelling with lids more than half closed: 4
-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, in a considerable area around the eye: 3.

TOOL USED TO ASSESS SCORE: ophtalmoscope of Heine (Microflex C-00.13.101), hand-slit lamp and fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: not rinsed
Irritation parameter:
cornea opacity score
Basis:
animal: #2, #4
Time point:
24/48/72 h
Score:
1.33
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: not rinsed
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.67
Reversibility:
fully reversible within: 4 d
Remarks on result:
other: not rinsed
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: not rinsed
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.67
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: not rinsed
Irritation parameter:
iris score
Basis:
animal: #1, #4, #5
Time point:
24/48/72 h
Score:
0.67
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: not rinsed
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: not rinsed
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 4 d
Remarks on result:
other: not rinsed
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Reversibility:
not fully reversible within: 7 d
Remarks on result:
other: not rinsed
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: #1, #5
Time point:
24/48/72 h
Score:
0.67
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: not rinsed
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.67
Reversibility:
fully reversible within: 4 d
Remarks on result:
other: not rinsed
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.34
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: not rinsed
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #6
Time point:
24/48/72 h
Score:
1.34
Reversibility:
fully reversible within: 4 d
Remarks on result:
other: not rinsed
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: not rinsed
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: not rinsed
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.33
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: not rinsed
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.67
Reversibility:
not fully reversible within: 7 d
Remarks on result:
other: not rinsed
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.33
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: not rinsed
Irritation parameter:
chemosis score
Basis:
animal: #5, #6
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: not rinsed

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
The test substance was found to be not irritant when applied to intact rabbit eye.
Executive summary:

The substance was tested for eye irritation according to the guideline inserted into the "Code of Federal Regulations", Title 16, Section 1500.42. 100 mg of the test item were introduced into the right eye of six rabbits; the left eye served as a control. Evaluations were made by comparison with the control eye. The readings were made 1, 24, 48 hours and 4 and 7 days after the administration of the test substance.

In all animals the effects on the cornea, iris or conjunctiva were reversible within the 7 day-study period. The only two effects that were not reversible within the observation period were chemosis (grade 1 in animal #3) and iritis (grade 1 in animal #6). It should be noted that the eyes were not rinsed. Moreover, considering that the rest of the effects were reversible within the observation period, it could be expected that the latest effects will reverse within the 21 day-period (as reported in the CLP Regulation) instead of the 7 day-observation period. Only three animals out of six showed a mean score (24/48/72 h)≥1 for corneal opacity and for iritis (#2, #3, #4 and #2, #3, #6 respectively). All animals showed conjunctival erythema (redness) and oedema (swelling) (chemosis)mean values (24/48/72 h) < 2, except for one animal (#2: chemosis 2.33).