Tetrasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[(2-methyl-4-sulphonatophenyl)azo]naphthalene-2-sulphonate]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November from 6th to 11th, 1984

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:

1984

Report date:

1984

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted May 12, 1981

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Direct Orange 118

IUPAC Name:

Direct Orange 118

Specific details on test material used for the study:

The test article was applied undiluted.

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: 14 - 15 weeks
- Weight at study initiation: 2.2 - 2.8 kg
- Housing: individually in stainless steel cages equipped with an automatic cleaning and drinking system.
- Diet: pelleted standard Kliba 341, Batch 1/84 rabbit maintenance diet, ad libitum.
- Water: community tap water from ltingen, ad libitum.
- Acclimation period: 4 days under laboratory conditions after veterinary examination.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Relative humidity: 55 ± 10 %
- Air changes: 10-15 air changes per hour.
- Photoperiod: 12 hours artificial fluorescent light/12 hours dark.
- Other: at least 8 hours music/light period.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

A single dose was administered to the left eye of each animal. The application volume was 0.1 g per animal.

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

2 males and 1 female

Details on study design:

OBSERVATIONS
- Viability Mortality: Daily.
- Body Weights: pre-test, day 1 and at termination of test.

TOOL USED TO ASSESS SCORE: eye examinations were made with a slit-lamp 30 SL and a Varta Cliptrix diagnostic-lamp.

SCORING SYSTEM
The eyes of each animal were examined 1-, 24-, 48- and 72 hours after administration. The irritation was assessed according to the OECD Guidelines for testing of Chemicals, Section 4, number 405 "Acute Eye Irritatian/Carrosion" adopted May 12, 1981.
The corrosive properties of the test article and the color of the treated eye were described and recorded.

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 luster), details of iris clearly visible 1
Easily discernible translucent area 1 details of iris slightly obscured 2
Nacrous 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 rugaeI, congestion, swelling, moderate circumcorneal hyperemia, or injection, any of these or combination thereof, iris still reacting to light (sluggish reaction is positive) 1
No reaction to light, hemorrhage, 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 hyperemic (injected) 1
Diffuse, crimson color, individual vessels not easily discernible 2
Diffuse beefy red 3

Chemosis: lids and/or 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: 3/3

Time point:

24/48/72 h

Score:

< 1

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 1

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 2

Results 4

Irritation parameter:

chemosis score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 2

Irritant / corrosive response data:

The substance showed a primary irritation score of 1.2 when applied to the rabbit eye mucosa.
In the area of application an orange discoloration of the cornea and conjunctivae which could be related to effects of the test article was observed.
No corrosion of the cornea was observed at each of the measuring intervals.

TOXIC SYMPTOMS I MORTALITY
No acute toxic symptoms were observed in the animals during the test period and no mortality occurred.

BODY WEIGHTS
The body weight gain of all rabbits was similar.

Any other information on results incl. tables

Reaction observed

Animal	Reaction	1 hr	24 hrs	48 hrs	72 hrs	Mean 24/48/72 hrs
359 M	Cornea opacity	0	0	0	0	0.0
360 M	Cornea opacity	0	0	0	0	0.0
361 F	Cornea opacity	0	0	0	0	0.0
359 M	Iris	0	0	0	0	0.0
360 M	Iris	0	0	0	0	0.0
361 F	Iris	0	0	0	0	0.0
359 M	Conjunctival redness	0	0	0	0	0.0
360 M	Conjunctival redness	0	1	1	1	1.0
361 F	Conjunctival redness	0	1	1	1	1.0
359 M	Conjunctival chemosis	2	1	0	0	0.3
360 M	Conjunctival chemosis	1	1	0	0	0.3
361 F	Conjunctival chemosis	2	1	0	0	0.3

Applicant's summary and conclusion

Interpretation of results:

other: not classified, according to the CLP Regulation (EC) No 1272/2008

Conclusions:

Not classified, according to the CLP Regulation (EC) No 1272/2008

Executive summary:

The study was performed to assess the possible irritation potential when single doses of test item are placed in the conjunctival sac of rabbit eyes. The experiment was conducted in accordance with the method and procedures described into the OECD guideline 404.

Under the conditions of the experiment the substance was found to cause a primary irritation score of 1.2 when applied to the rabbit eye mucosa.

In the area of application an orange discoloration of the conjunctivae was observed, which could be related to effects of the test article.

No corrosion was observed at each of the 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 of the three tested animals.

Therefore, the substance does not meet the criteria to be classified as eye irritating, according to the CLP Regulation (EC) No 1272/2008.