Sodium [3-hydroxy-4-[(1-hydroxy-5-sulpho-2-naphthyl)azo]naphthalene-1-sulphonato(4-)]chromate(1-)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: United States Environmental Protection Agency (EPA) Paragraph 163.81-5 "Primary eye irritation study" Federal Register, Vol. 43, No. 163, August 22, 1978.

Deviations:

not specified

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium [3-hydroxy-4-[(1-hydroxy-5-sulpho-2-naphthyl)azo]naphthalene-1-sulphonato(4-)]chromate(1-)

EC Number:

289-530-3

EC Name:

Sodium [3-hydroxy-4-[(1-hydroxy-5-sulpho-2-naphthyl)azo]naphthalene-1-sulphonato(4-)]chromate(1-)

Cas Number:

89899-25-2

Molecular formula:

C20H10CrN2O8S2.Na

IUPAC Name:

Sodium [3-(hydroxy-​κO)-4-{[1-(hydroxy-​κO)-5-sulfonaphthalen-2-yl]diazenyl-​κN1}naphthalene-1-sulfonato(4-)]chromate(1-)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

None

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Remarks:

After checking for normal ophthalmic conditions

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 3 to 4 months
- Weight at study initiation: Males: 2- 3 kgs
- Housing: Caged singly
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAGAG/ Gossau, SG (Switzerland), ad libitum
- Water: ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature: 22±3 °C
- Humidity: 55±15%
- Photoperiod: Animals were exposed to artificial light for 12 hours light/day
- Air changes: 15 air changes/h

Test system

Vehicle:

not specified

Controls:

other: untreated right eye

Amount / concentration applied:

- Amount(s) applied: 0.1 ml

Duration of treatment / exposure:

Unwashed eye: unspecified (not rinsed after single instillation)
Washed eye: 30 sec

Observation period (in vivo):

7d

Number of animals or in vitro replicates:

Six rabbits (three males and three females)

Details on study design:

PROCEDURE:
-The procedure used is based but not in every part identical with the Proposed Guidelines of the United States Environmental Protection Agency (EPA)
Paragraph 163.81-5 "Primary eye irritation study"r Federal Register, Vol. 43 No. 163 August 22, 1978.

- The test material in an amount of 0.1 ml was inserted in the conjunctival sac of the left eye of the rabbits and the lids were gently closed for 15 seconds. The right eye was not treated and served as an untreated control.
- The eye irritation was assessed with a slit-lamp at 24, 48, 72 hours and 4 and 7 days after treatment

REMOVAL OF TEST SUBSTANCE
In 3 of the 6 rabbits approximately 30 seconds after the treatment the treated eye was flushed with 10 ml of sterile physiological saline.

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:

SCORING SYSTEM:

Cornea
A. Opacity and degree of density (area most dense taken for reading)
No opacity 0
Scattered or diffuse areas, details of iris clearly visible 1
Easily discernible translucent areas, details of iris slightly obscured 2
Opalescent areas, no details of iris visible, size of pupil barely discernible 3
Opaque, iris invisible 4

B. Area of cornea involved
One quarter (or less) but not zero 1
Greater than one quarter, but less than half 2
Greater than half, but less than three quarters 3
Greater than three quarters, up to whole area 4
A x B x 5 Maximum possible score = 80

Iris
A. Values
Normal 0
Folds above normal, congestion, swelling, circumcornea injection (any or all of these or combination of any thereof) iris still reacting to light (sluggish reaction is positive) 1
No reaction to light, hemorrhage, gross destruction (any or all of these) 2
A x 5 Maximum possible score = 10

Conjunctivae
A. Redness (refers to palpebral and bulbar conjunctivae, excluding cornea and iris)
Blood vessels normal 0
Vessels definitely injected above normal 1
More diffuse, deeper crimson red, individual vessels not easily discernible 2
Diffuse beefy red 3

B. Chemosis
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 about half closed to completely closed 4

C. Discharge
No discharge 0
Any amount different from normal (does not include small amounts observed in inner canthus of normal animals) 1
Discharge with moistening of the lids and hairs just adjacent to lids 2
Discharge with moistening of the lids and hairs, and considerable area around the eye 3
(A + B + C) x 2 Maximum possible score = 20

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:

4

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:

2

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No signs of abnormal reaction was seen in any animals after application of the test substance. Hence the primary irritation index was 0.

Other effects:

No abnormalities reported.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 20290/A was considered to be not an eye irritant.

Executive summary:

A study was conducted to assess the eye irritancy potential of the test substance in rabbits according to United States Environmental Protection Agency (EPA) Paragraph 163.81-5 "Primary eye irritation study Federal Register, Vol. 43 No. 163 August 22, 1978.

The test material in an amount of 0.1 ml was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for 15 seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after the treatment the treated eye was flushed with 10 ml of sterile physiological saline. The eye irritation was assessed with a slit-lamp at 24, 48, 72 hours and 4 and 7 days after treatment.

No signs of abnormal reaction were seen in any animals after application of the test substance. Hence the primary irritation index was 0. Hence, based on the findings of the study, FAT 20290/A was not an eye irritant.