Sodium sulphanilate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 09 May 1995 to 16 May 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline and EU method. GLP study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

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:

Sodium sulphanilate

EC Number:

208-208-5

EC Name:

Sodium sulphanilate

Cas Number:

515-74-2

Molecular formula:

C6H7NO3S.Na

IUPAC Name:

sodium 4-aminobenzenesulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Physical state: white powder
- Analytical purity: 91.5%
- Lot/batch No.: 868 TO
- Storage condition of test material: room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Interfauna UK Ltd., Wyton, Huntingdon, England
- Weight at study initiation: 4.3-4.6 kg
- Housing: The rabbits were individually housed in stainless steel cages with flat rod bases or plastic cages with perforated bases, under standardized conventional conditions.
- Diet (e.g. ad libitum): Standard diet "Ssniff K4", approx. 100-120 g per animal/day; once per day in the morning.
- Water (e.g. ad libitum): Tap water; ad libitum.
- Acclimation period: About two weeks.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 ºC (higher when ambient temperature over 24 ºC)
- Humidity (%): 50-70%
- Air changes (per hr): 12-15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours, artificial illumination from 6 a.m. to 6 p.m.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: no (the other eye remained untreated and served as control).

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µl of the pulverize test substance (equivalent to approximately 41 mg)

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

1, 24, 48 and 72 hours and 7 days

Number of animals or in vitro replicates:

Three animals

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye was rinsed with normal saline.
- Time after start of exposure: 24 hours

SCORING SYSTEM:
Cornea
Opacity: degree of density
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible 1
Easily discernible translucent area, details of iris slightly obscured 2
Nacreous area, no details of iris visible, size of pupil barely discernible 3
Completely opaque cornea, iris not discernible through the opacity 4

Iris
Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, iris still reacting to light (sluggish reaction is positive) 1
No reaction to light, haemorrhage, gross destruction 2

Conjunctivae
Erythema (redness)
Blood vessels normal 0
Some blood vessels definitely hyperaemic (injected) 1
Diffuse, crimson colour, individual vessels not easily discernible 2
Diffuse, beefy redness 3

Chemosis
No swelling 0
Any swelling above normal (includes nictitating membranes) 1
Obvious swelling, with partial eversion of lids (ectropium) 2
Swelling, with lids about half closed 3
Swelling, with lids more than half closed 4

TOOL USED TO ASSESS SCORE: hand-slit lamp. To define epithelial damage, one drop of a 1% fluorescein solution was applied to the corneal surface 24 hours after administration of the test substance. Evaluation was performed by means of ultraviolet illumination in a darkened room and diffuse white illumination.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24-72 h

Score:

0

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 24-72 h

Score:

0

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: 24-72 h

Score:

0

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24-72 h

Score:

0

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 24-72 h

Score:

0

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: 24-72 h

Score:

0

Results 7

Irritation parameter:

other: conjunctivae score: redness

Basis:

animal #1

Time point:

other: 24-72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 8

Irritation parameter:

other: conjunctivae score: redness

Basis:

animal #2

Time point:

other: 24-72 h

Score:

0.67

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Results 9

Irritation parameter:

other: conjunctivae score: redness

Basis:

animal #3

Time point:

other: 24-72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24-72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24-72 h

Score:

0.67

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 24-72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Any other information on results incl. tables

Table 1: Eye irritation scores

 

Animal	Region of eye	24 h	48 h	72 h	7 d
1	Cornea	0	0	0	0
	Iris	0	0	0	0
	Conjunctivae erythema	1	1	1	0
	Conjunctivae swelling	1	0	0	0
2	Cornea	0	0	0	0
	Iris	0	0	0	0
	Conjunctivae erythema	1	1	0	0
	Conjunctivae swelling	1	1	0	0
3	Cornea	0	0	0	0
	Iris	0	0	0	0
	Conjunctivae erythema	1	1	1	0
	Conjunctivae swelling	1	0	0	0

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The results of the exposure of the test substance to the eye indicate that the test substance may be regarded as not irritating to the eye.

Executive summary:

The acute ocular irritation/corrosion study was performed according to the OECD Guideline No. 405 and EU Method B.5. The test item in the amount of 0.1 mL was placed into the conjunctival sac of one eye of each of three rabbits. 24 hours after instillation of the test substance the treated eye was rinsed with normal saline. Eye irritation was scored and recorded at 1, 24, 48 and 72 hours and 7 days after the end of the exposure. The results of the exposure of the test substance to the eye indicate that the test substance may be regarded as not irritating to the eye.