Tetrasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[(6-sulphonato-2-naphthyl)azo]naphthalene-2-sulphonate]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

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:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: EPA guideline (§ 163.81-4 "Primary eye irritation study". Federal Register, Vol. 43, No. 163, August 22, 1978)

GLP compliance:

no

Remarks:

pre-GLP

Test material

Test material information

Constituent 1

Reference substance name:

FAT 11178/B

IUPAC Name:

FAT 11178/B

Details on test material:

- Name of test material (as cited in study report): FAT 11178/B
- Physical appearance: red powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Exp. Toxicology Sisseln, CIBA-Geigy Ltd.
- Weight at study initiation: 2 - 3 kg
- Housing: single housing in metal cages
- Diet: standard rabbit food ad libitum (NAFAG, No. 814, Gossau SG)
- Water: ad libitum
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 14 / 10

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of same animal

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 g

Duration of treatment / exposure:

30 seconds (rinsed) or unspecified (unrinsed)

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

6 (3 males + 3 females)

Details on study design:

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

SCORING SYSTEM: according to Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp

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

Reversibility:

other: not applicable

Remarks on result:

other: unrinsed

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: rinsed

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

other: unrinsed

Results 4

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

other: rinsed

Results 5

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.4

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: unrinsed

Results 6

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Remarks on result:

other: rinsed

Results 7

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.2

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: unrinsed

Results 8

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: rinsed

Irritant / corrosive response data:

The TS was found to cause a minimal irritation when applied to the rabbit eye mucosa. Irritation was fully reversible within 72 hours. When the application site was rinsed, no irritation was found.

Other effects:

During the whole observation period parts of the cornea and sclera were reddish stained.

Any other information on results incl. tables

Individual ocular examinations and mean values, unrinsed eyes (24, 48, 72 hours):

Readings	Animal	Cornea		Iris	Conjunctiva
		Opacity	Area of cornea involved		Redness	Chemosis	Discharge
24 h	01	0	0	0	2	1	0
	02	0	0	0	0	0	0
	03	0	0	0	1	1	1
48 h	01	0	0	0	0	0	0
	02	0	0	0	1	0	0
	03	0	0	0	0	0	0
72 h	01	0	0	0	0	0	0
	02	0	0	0	0	0	0
	03	0	0	0	0	0	0
Mean	01	0.0		0.0	0.7	0.3
	02	0.0		0.0	0.3	0.0
	03	0.0		0.0	0.3	0.3
Mean		0.0		0.0	0.4	0.2

 

Individual ocular examinations and mean values, rinsed eyes (24, 48, 72 hours):

Readings	Animal	Cornea		Iris	Conjunctiva
		Opacity	Area of cornea involved		Redness	Chemosis	Discharge
24 h	01	0	0	0	0	0	0
	02	0	0	0	0	0	0
	03	0	0	0	0	0	0
48 h	01	0	0	0	0	0	0
	02	0	0	0	0	0	0
	03	0	0	0	0	0	0
72 h	01	0	0	0	0	0	0
	02	0	0	0	0	0	0
	03	0	0	0	0	0	0
Mean	01	0.0		0.0	0.0	0.0
	02	0.0		0.0	0.0	0.0
	03	0.0		0.0	0.0	0.0
Mean		0.0		0.0	0.0	0.0

 

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Remarks:

Migrated information

Conclusions:

Under the conditions of this experiment the test material was found to cause a minimal irritation when applied to the rabbit eye mucosa and no irritation when the application site was rinsed. Taken together, the test material is considered to be not irritating to the eye.

Executive summary:

The test item contained 89% active ingredient and 10% urea. Three male and female New Zealand rabbits were treated with 0.1 g by insertion into the conjunctival sac of the left eye. The lids were gently closed for a few seconds. In three of the rabbits, the treated eye was flushed with 10 ml of physiological saline after ca. 30 seconds. The eye irritation was assessed after 1, 2, 3, 4 and 7 days. Only in non-rinsed eyes, redness, chemosis and discharge were observed on the first and second day. These findings were no longer noted on the third day. During the whole observation period, parts of the cornea and sclera were reddish stained.