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Diss Factsheets

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Principles of method if other than guideline:
Test conducted following Code of Federal Regulations, Title 16, section 1500.42
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Acid Orange 116
IUPAC Name:
Acid Orange 116
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: 3.2 kg
- Housing: individual cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 - 14 d

ENVIRONMENTAL CONDITIONS
- Temperature: 16-18 °C
- Humidity: 40 %
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Controls:
yes, concurrent no treatment
Amount / concentration applied:
Single application of 100 µl bulk volume of amorphous substance in conjunctiva of right lower eyelid. The eyelids were then gently held together for 1 second.
Duration of treatment / exposure:
The eye was not rinsed after application.
Observation period (in vivo):
24, 48, 72 h up to 8 d.
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM:
Corneal opacity
0 no opacity
1 opacity on scattered districts. Details of the iris clearly visible
2 easily recognizable, translucent districts of opacity. Details of the iris slightly darkened
3 pearly-like opacity. No details of the iris visible. Size of the pupil barely distinguishable
4 complete corneal opacity. Iris invisible

Iris
0 normal
1 conspicuous deep-drawn wrinkles, hyperaemia, swelling, circumcorneal vascular drawing (any or all of these symptoms or combination of them). Iris still reacts to light (sluggish reaction to light is considered positive)
2 no reaction to light, bleeding, gross destruction of the iris (any or all of these symptoms)

Conjunctivae redness
0 vessels normal
1 vessels clearly injected
2 diffuse, crimson reds. Individual vessels not easily distinguishable
3 diffuse, fleshy redness

Conjunctivae chemosis
0 no swelling
1 slight swelling (any swelling above normal).
2 distinct swelling with partial lifting of the lid (ectropion)
3 swelling, with the eyelids half closed
4 swelling with more than half to fully closed eyelids

TOOL USED TO ASSESS SCORE: ophthalmoscope. The corneal findings were confirmed with the fluorescein test after 8 days (instillation of 1 drop of fluorescein solution in ophthalmological preparation directly onto the cornea. After rinsing with physiological saline solution, corneal damage appears yellow-green, UV light or cobalt blue filter).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
animal: #1,#2,#3,#5,#6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation

Any other information on results incl. tables

rabbit no. 24 h 48 h 72 h 8 d
1 2 3 4 5 6 1 2 3 4 5 6 1 2 3 4 5 6 1 2 3 4 5 6
cornea opacity 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
iris 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
conjunctivae redness 1 1 1 1 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
conjunctivae chemosis 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:
other: not eye irritant according to the CLP Regulation (EC 1272/2008)
Conclusions:
Not irritant to rabbit eye.
Executive summary:

Method

Eye irritation assessement based on Code of Federal Regulations, Title 16, section 1500.42. Test substance was placed in one eye of 6 rabbits, while the other eye served as control. Treated eye was not rinsed. Observations were done after 24 h , 48 h, 72 h and up to 8 d after starting of experiment.

Results

Neither corneal opacity nor iritis were noted in rabbits; slight chemosis was noted in 1/6 rabbits, that however was reversible within 48 h. Slight conjunctivae redness was noted in 6/6 rabbits, that was reversible within 48 h.