Disodium [4-hydroxy-3-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Disodium [4-hydroxy-3-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)

EC Number:

271-351-7

EC Name:

Disodium [4-hydroxy-3-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)

Cas Number:

68541-71-9

Molecular formula:

C32H17CrN6O11S.2Na

IUPAC Name:

disodium [4-hydroxy-3-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)

Test material form:

other: solid

Details on test material:

None

Specific details on test material used for the study:

Test article: FAT20011/D
Additional specification: Lanacron Marine S-Grohfeucht
Batch No.: 61
Purity/Contents: CA.52.5%
Physical properties: Solid
Storage conditions: room temperature
Validity: July 1999
Safety precautions: gloves and face masks
Test material received: March22, 1994

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Chemisch-pharmazeutische Fabrik, D-88397 Biberach.
- Weight at study initiation: 1040-2340 g.
- Housing: Animalss were housed individually in metal cage, identified by ear tattoo.
- Diet : Rabbit food, NAFAG, N°. 814 Tox, NAFAG AG, Gossau, SG (Switzerland); ad libitum.
- Water: e.g. ad libitum.
- Acclimation period: 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3.
- Humidity (%): 30-70.
- Photoperiod: 12 hours light/day.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

One application

Observation period (in vivo):

7 days, because reactions were observed within 72 hours after instillation of the test article.

Number of animals or in vitro replicates:

3 rabbits (1 male and 2 females)

Details on study design:

Application of the substance:
The test article was applied with a spatula. 100 mg of FAT 20011/D was placed into the conjunctival sac of the left 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 article. The right eye remained untreated and served as a control. The animals were checked daily for mortality. The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of FAT 20011/D according to the OECD scoring system.

SCORING SYSTEM: Scale for scoring Ocular Lesions.
Cornea
Opacity-degree of density (area most dense taken for reading)
- No ulceration or opacity: 0
- Scattered or diffuse area of opacity , other than slight dulling of normal lustre), details of iris clearly visible: 1
- Easily discernible translucent areas, 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

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

Conjunctivae
Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
- Blood vessels normal: 0
- Some blood vessels definitely : 1
- Diffuse, crimson colour, individual vessels not easily discernible: 2
- Diffuse beefy red: 3

Chemosis
Lids and or nictating membrane
- No swelling: 0
- Any swelling above normal (includes nictitating membrane): 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 #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48h

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

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 7

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72h

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 10

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible within: 24h

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 20011/D is considered to be non-irritant to the eyes rabbits.

Executive summary:

The purpose of this study was to determine the eye irritating potency of FAT 20011/D. The study was performed according to OECD Guideline 405 and EU Method B.5, in compliance with GLP. 3 rabbits were used to performed the test (1 males and 2 females). 100 mg of FAT 20011/D was placed into the conjunctival sac of the left 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 article. The right eye remained untreated and served as a control. The animals were checked daily for systemic symptoms and mortality. The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of FAT 20011/D according to the OECD scoring system. Mild irritation reactions were seen with iris and conjunctiva, which were mostly reversible within 7 days. Hence, FAT 20011/C is considered to be non-irritant to the eyes rabbits.