Disodium 7-[[2-(acetylamino)-4-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]phenyl]azo]naphthalene-1,3-disulphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February from 21st to 27th, 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted May 12, 1981

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Reactive Yellow 125

IUPAC Name:

Reactive Yellow 125

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf / Switzerland.
- Age at study initiation: 15 - 16 weeks.
- Weight at study initiation: 2.4 - 2.5 kg
- Acclimation period: 3 days.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

1 male and 1 female

Details on study design:

TOOL USED TO ASSESS SCORE: hand-slit lamp 30 SL and Varta Cliptrix diagnostic-lamp.

SCORING SYSTEM

CORNEAL IRRITATION
Opacity: degree of density (densest area used for assessment)
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight dulling of normal Iuster), details of iris clear visible 1
Easily discernible translucent area, details of iris slightly obscured 2
Nacreous area, no details of iris visible, size of pupil barely discernible 3
Opaque cornea, iris not discernible through the opacity 4

IRIDIC IRRITATION
Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any of these or combination thereof, iris still reacting to light (sluggish reaction is positive) 1
No reaction to light, haemorrhage, gross destruction (any or all of these) 2

CONJUNCTIVAL IRRITATION
Redness (refers to palpebral and bulbar conjunctivae, 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, lid and/on nictating membranes
No swelling 0
Any swelling above normal (includes nictating membranes) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids more than half closed 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: 2/2

Time point:

24/48/72 h

Score:

< 1

Reversibility:

fully reversible within: 72 hrs

Results 2

Irritation parameter:

iris score

Basis:

animal: 2/2

Time point:

24/48/72 h

Score:

< 1

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: 2/2

Time point:

24/48/72 h

Score:

< 2

Reversibility:

fully reversible within: 72 hrs

Results 4

Irritation parameter:

chemosis score

Basis:

animal: 2/2

Time point:

24/48/72 h

Score:

< 2

Reversibility:

fully reversible within: 48 hrs

Irritant / corrosive response data:

Under the conditions of the experiment, test item was found to cause a primary irritation score of 1.3 when applied to rabbit eye mucosa. In the area of application, a slight, hardly perceptible yeIlowish-orange discolouration of the cornea and conjunctivae was observed, which could be related to effects of the test article.
No corrosion effect has occurred at each measuring intervals.

Any other information on results incl. tables

Animal N	Reaction	1 hr	24 hrs	48 hrs	72 hrs
15 M	Cornea opacity	0	0	0	0
16 F	Cornea opacity	0	0	1	0
15 M	Iris	0	0	0	0
16 F	Iris	0	0	0	0
15 M	Conjuntivae redness	0	1	1	0
16 F	Conjuntivae redness	1	1	1	0
15 M	Conjuntivae chemosis	2	0	0	0
16 F	Conjuntivae chemosis	1	1	0	0

Applicant's summary and conclusion

Interpretation of results:

other: not classified, according to the CLP Regulation (EC) 1272/2008

Conclusions:

Not eye irritating

Executive summary:

The primary eye irritation potential of the substance was investigated according to OECD test guideline no. 405. The test item was applied undiluted, to one male and one female New Zealand White rabbits. The scoring of skin reactions was performed 1, 24, 48 and 72 hours.

Under the conditions of the experiment, test item was found to cause a primary irritation score of 1.3 when applied to rabbit eye mucosa. In the area of application, a slight, hardly perceptible yeIlowish-orange discolouration of the cornea and conjunctivae was observed, which could be related to effects of the test article.

No corrosion effect has occurred at each measuring intervals.

Conclusion

The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and oedema, in all the tested animals.

Although two animals, instead of three, the results can be considered as sufficiently clear and probative to conclude that the test item does not meet the criteria to be classified as irritating, according to the CLP Regulation (EC) No 1272/2008.