Sodium 6-amino-4-hydroxy-5-[[2-(phenylsulphonyl)phenyl]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:

1979

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:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: "Code of Federal Regulations", Title 16, Section 1500.42

Principles of method if other than guideline:

100 mg of the test item were introduced into the right eye of six rabbits; the left eye served as a control. Evaluations were made by comparison with the control eye. The readings were made 1, 24, 48 hours and 4 and 7 days after the administration of the test substance.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Acid Red 042

IUPAC Name:

Acid Red 042

Test material form:

solid: particulate/powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.5 kg
- Housing: The rabbits are kept either in individual cages measuring 540 x 350 x 315 mm. or in restraining devices.
- Diet: 200 g of food is provided per animal per day in the form of granules (Granulés Lapin "entretien" SANDERS)
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 20 %
- Air changes: 12 air change per hour

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 100 mg

Duration of treatment / exposure:

Single injection

Observation period (in vivo):

1, 24, 48, 72 hours and 4 and 7 days

Number of animals or in vitro replicates:

Six rabbits

Details on study design:

SCORING SYSTEM
CORNEA
-Opacity: degree of density (area most dense taken for reading)
No opacity. Neighter loss of brilliance nor gloss: 0
Opacity scattered or diffuse, details of iris clearly visible: 1
Translucent zone easily discernable, details of iris slight obscured: 2
Opalescent zone, no details of iris visible, size of pupil barely discernable: 3
Cornea completely opaque, iris invisible: 4
-Area of cornea affected
No ulceration or opacity: 0
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
IRIS
No anomaly: 0
Iris clearly more folded than normal, congestion , swelling, circumcorneal injection (any one or all of these), iris still reacting to light (sluggish reaction is positive): 1
No reaction to light, haemorrhage ; gross destruction (any one 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 hyperaemic (injected): 1
Diffuse, crimson colour, individual vessels not easily discernible: 2
Diffuse beefy red: 3
-Chemosis: lids and/or nictating membrane
No swelling: 0
Slight swelling (includes nictating membrana): 1
Obvious swelling with partial eversion of lids: 2
Swelling with lids about half closed: 3
Swelling with lids more than half closed: 4
-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, in a considerable area around the eye: 3.

TOOL USED TO ASSESS SCORE: ophtalmoscope of Heine (Microflex C-00.13.101), hand-slit lamp and fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: not rinsed

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal: #2, #4

Time point:

24/48/72 h

Score:

1.33

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: not rinsed

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.67

Reversibility:

fully reversible within: 4 d

Remarks on result:

other: not rinsed

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0.33

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: not rinsed

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0.67

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: not rinsed

Results 6

Irritation parameter:

iris score

Basis:

animal: #1, #4, #5

Time point:

24/48/72 h

Score:

0.67

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: not rinsed

Results 7

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 7 d

Remarks on result:

other: not rinsed

Results 8

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 4 d

Remarks on result:

other: not rinsed

Results 9

Irritation parameter:

iris score

Basis:

animal #6

Time point:

24/48/72 h

Score:

1

Reversibility:

not fully reversible within: 7 d

Remarks on result:

other: not rinsed

Results 10

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal: #1, #5

Time point:

24/48/72 h

Score:

0.67

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: not rinsed

Results 11

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.67

Reversibility:

fully reversible within: 4 d

Remarks on result:

other: not rinsed

Results 12

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.34

Reversibility:

fully reversible within: 7 d

Remarks on result:

other: not rinsed

Results 13

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #6

Time point:

24/48/72 h

Score:

1.34

Reversibility:

fully reversible within: 4 d

Remarks on result:

other: not rinsed

Results 14

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #4

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: not rinsed

Results 15

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: not rinsed

Results 16

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.33

Reversibility:

fully reversible within: 7 d

Remarks on result:

other: not rinsed

Results 17

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.67

Reversibility:

not fully reversible within: 7 d

Remarks on result:

other: not rinsed

Results 18

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1.33

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: not rinsed

Results 19

Irritation parameter:

chemosis score

Basis:

animal: #5, #6

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: not rinsed

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

The test substance was found to be not irritant when applied to intact rabbit eye.

Executive summary:

The substance was tested for eye irritation according to the guideline inserted into the "Code of Federal Regulations", Title 16, Section 1500.42. 100 mg of the test item were introduced into the right eye of six rabbits; the left eye served as a control. Evaluations were made by comparison with the control eye. The readings were made 1, 24, 48 hours and 4 and 7 days after the administration of the test substance.

In all animals the effects on the cornea, iris or conjunctiva were reversible within the 7 day-study period. The only two effects that were not reversible within the observation period were chemosis (grade 1 in animal #3) and iritis (grade 1 in animal #6). It should be noted that the eyes were not rinsed. Moreover, considering that the rest of the effects were reversible within the observation period, it could be expected that the latest effects will reverse within the 21 day-period (as reported in the CLP Regulation) instead of the 7 day-observation period. Only three animals out of six showed a mean score (24/48/72 h)≥1 for corneal opacity and for iritis (#2, #3, #4 and #2, #3, #6 respectively). All animals showed conjunctival erythema (redness) and oedema (swelling) (chemosis)mean values (24/48/72 h) < 2, except for one animal (#2: chemosis 2.33).