Sodium 3-[[3-methoxy-4-[(4-methoxyphenyl)azo]phenyl]azo]benzenesulphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Study completion date - 14 August 1978

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:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 3-[[3-methoxy-4-[(4-methoxyphenyl)azo]phenyl]azo]benzenesulphonate

EC Number:

264-129-6

EC Name:

Sodium 3-[[3-methoxy-4-[(4-methoxyphenyl)azo]phenyl]azo]benzenesulphonate

Cas Number:

63405-85-6

Molecular formula:

C20H18N4O5S.Na

IUPAC Name:

sodium 3-({3-methoxy-4-[(4-methoxyphenyl)diazenyl]phenyl}diazenyl)benzenesulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

None

Specific details on test material used for the study:

Name: FAT 20004/D
Purity: 61 %

Test animals / tissue source

Species:

rabbit

Strain:

Himalayan

Details on test animals or tissues and environmental conditions:

TEST ANIMALS

- Weight at study initiation: 1.5 to 2 kgs
- Housing: Housed individually in metal cages
- Diet: NAFAG, Gossau SG ad libitum
- Water: Water, ad libitum
- Acclimation period: 4 days


ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C
- Humidity: 55 ± 5 %
- Photoperiod: 10 hour light cycle

Test system

Vehicle:

not specified

Controls:

yes, concurrent no treatment

Amount / concentration applied:

- Amount(s) applied: 100 mg

Duration of treatment / exposure:

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

Observation period (in vivo):

The rabbits were examined for day 1, 2, 3, 4 and 7 d after application of the test.

Number of animals or in vitro replicates:

Six animals (Three males and three females)

Details on study design:

PROCEDURE:
The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the 6 rabbits and the lids were gently closed for one second. The right eye was not treated and served as an untreated control.

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

SCORING SYSTEM: The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit. The primary eye irritation index represents the sum of the mean values for cornea, iris and conjunctivae. This procedure was carried out separately for unrinsed and rinsed eyes, respectively.

SCORING SYSTEM: Scale for scoring Ocular Lesions.
1.Cornea
(A) Opacity-degree of density (area most dense taken for reading)
- No opacity: 0
- Scattered or diffuse area, 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

AxBx5 Total maximum=80

2.Iris
(A) Values
- Normal: 0
- Folds above normal, congestion, swelling, circumcorneal 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, haemorrhage, gross destruction (any or all of these): 2
Ax5 Total maximum=10

3.Conjunctivae
(A) Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
- 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
Score (a+b+c)x 2 Total maximum=20

TOOL USED TO ASSESS SCORE: slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

Rinsed eyes

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Remarks:

Rinsed eyes

Basis:

mean

Remarks:

3 animals

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:

Rinsed eyes

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

chemosis score

Remarks:

Rinsed eyes

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

cornea opacity score

Remarks:

Not rinsed eyes

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

1.11

Max. score:

4

Reversibility:

fully reversible within: 96 h

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

iris score

Remarks:

Not rinsed eyes

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

conjunctivae score

Remarks:

Not rinsed eyes

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

1.5

Max. score:

3

Reversibility:

fully reversible within: 96 h

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

chemosis score

Remarks:

Not rinsed eyes

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

1.5

Max. score:

4

Reversibility:

fully reversible within: 96 h

Remarks on result:

no indication of irritation

Any other information on results incl. tables

	Unrinsed Eyes									Rinsed Eyes
Days after Appl.	Rabbit 1 (Male)			Rabbit 2 (Male)			Rabbit 3 (Male)			Rabbit 4 (Female)			Rabbit 5 (Female)			Rabbit 6 (Female)
	Cornea	Iris	Conjuctiva	Cornea	Iris	Conjuctiva	Cornea	Iris	Conjuctiva	Cornea	Iris	Conjuctiva	Cornea	Iris	Conjuctiva	Cornea	Iris	Conjuctiva
1	0	0	12	10	0	12	10	0	12	0	0	0	0	0	0	0	0	0
2	0	0	6	10	0	10	10	0	8	0	0	0	0	0	0	0	0	0
3	0	0	6	5	0	8	5	0	6	0	0	0	0	0	0	0	0	0
4	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
5	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
6	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
7	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Cornea: 3.3		Iris: 0		Conjuctivae: 5.3						Cornea: 0		Iris: 0		Conjuctivae: 0

effect of rinsing R = unrinsed eyes 2.9

rinsed eyes 0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the test substance was considered to be an non-irritant to rabbit eyes.

Executive summary:

A study was conducted to assess the eye irritancy potential of the test substance in rabbits according to procedure "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO). The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the six rabbits. The eyelids were then held closed for 1 second. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of lukewarm water. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit. In the present experiments the cornea, iris and conjunctivae scores were zero for rinsed eyes. Therefore, the test material was considered to be a non-irritant to rabbit eyes.