Sodium 6-amino-5-[[2-[(cyclohexylmethylamino)sulphonyl]phenyl]azo]-4-hydroxynaphthalene-2-sulphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 6-amino-5-[[2-[(cyclohexylmethylamino)sulphonyl]phenyl]azo]-4-hydroxynaphthalene-2-sulphonate

EC Number:

251-257-2

EC Name:

Sodium 6-amino-5-[[2-[(cyclohexylmethylamino)sulphonyl]phenyl]azo]-4-hydroxynaphthalene-2-sulphonate

Cas Number:

32846-21-2

Molecular formula:

C23H26N4O6S2.Na

IUPAC Name:

sodium 6-amino-5-({2-[cyclohexyl(methyl)sulfamoyl]phenyl}diazenyl)-4-hydroxynaphthalene-2-sulfonate

Test material form:

other: solid

Specific details on test material used for the study:

Test substance: FAT 20003/G
Batch No.: EN 200106.49
Physical properties: solid
Composition: 80.5%
Stability: stable at room temperature
Validity: guaranteed by the sponsor until June 1989.
Test material received: July 5, 1984.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Maedorin AG, CH-4414 Fuellinsdorf
- Age at study initiation: Approx. 12-14 weeks old
- Weight at study initiation: 2 to 3 kg
- Housing: The rabbits were kept individually in metal cages
- Diet: Standard rabbit pellet – Nafag No. 814, Gossau, Switzerland; ad libitum
- Water: Fresh water; ad libitum
- Acclimation period: 5 d

ENVIRONMENTAL CONDITIONS
- Temperature: 20±3 °C.
- Humidity: 30-70 %
- Photoperiod: 12 h dark/12 h light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the second eye on the treated animals served as control

Amount / concentration applied:

- Amount applied: 100 mg
- Concentration: Undiluted

Duration of treatment / exposure:

Duration of treatment same as observation period.

Observation period (in vivo):

The eyes were examined for any ocular reaction approx. 1, 24, 48, and 72 h after the treatment and up to 7 d for the reversibility of the eye reactions.

Number of animals or in vitro replicates:

3 males

Details on study design:

- 100 mg of test substance was placed into the conjunctival sac of the right eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test substance.
- The left eye remained untreated and was used as untreated control.
- The ocular reaction were evaluated 1, 24, 48, and 72 h after instillation test material with the aid of slit-lamp

SCORING SYSTEM: The ocular reactions were according to the OECD scoring system.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 7 d

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 d

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.66

Max. score:

4

Reversibility:

fully reversible within: 7 d

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 48 h

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 d

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 d

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.33

Max. score:

3

Reversibility:

fully reversible within: 7 d

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 d

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 7 d

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 7 d

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 7 d

Irritant / corrosive response data:

- Under the experimental conditions employed test substance induced irritation of the cornea, iris and conjunctiva when applied into the conjunctival sac of the rabbits.
- The eye reactions observed were reversible till the end of the observation period on 7 d.

Other effects:

The body weight of one animal decreased after the test substance instillation. However, it normalized until the end of the observation period.

Any other information on results incl. tables

none

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

The test substance is considered to be irritating to the eye.

Executive summary:

An in vivo study was conducted to evaluate the acute eye irritation potential of the test substance (at ca. 80.5 % purity) in New Zealand White rabbits according to OECD Guideline 405.

 

100 mg of the test substance was placed into the conjunctival sac of the right eye of three male New Zealand White rabbits without rinsing. The left eye remained untreated and was used for control purposes. Assessment of ocular damage/irritation was made approximately 1, 24, 48 and 72 h following treatment with the aid of slit-lamp.

 

Under the conditions of the study, the test substance produced irritation of the cornea, iris and conjunctiva which was reversible within 7 d. The scores for corneal opacity were >1 in all tested animals. Similarly the scores for conjunctival redness were ≥ 2 in all the tested animals, hence the classification criteria for eye irritation category 2 as prescribed in regulation (EC) No. 1272/2008 is fulfilled. Hence, the substance is considered to be irritating to the eye.

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