Sodium 3-[[4-[(2-ethoxy-5-methylphenyl)azo]-1-naphthyl]azo]benzenesulphonate

Eye irritation

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

Test material information

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

Results

Results 1

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

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 h

Results 4

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

Results 5

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.