Disodium [2-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-5-nitrobenzene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Study completion date: 08 April 1974

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:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: The procedure employed was that prescribed by The Food and Drugs Administration of the U.S.A. in The Federal Register (17 September 1964 S 191.12), a transcript of which is attached as Appendix 1 to this report.

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Disodium [2-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-5-nitrobenzene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)

EC Number:

282-316-0

EC Name:

Disodium [2-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-5-nitrobenzene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)

Cas Number:

84145-95-9

Molecular formula:

C32H17CrN6O11S.2Na

IUPAC Name:

disodium [2-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-5-nitrobenzene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)

Test material form:

solid: particulate/powder

Details on test material:

Identity FAT 20013/D TE
Batch 1502011 (China)
Purity determined in this study
Appearance black powder at 20°C
Smell neutral
pH-Value pH-value of a solution of 2% (w/w) = 9.2
Expiration date August 03rd, 2020
Storage to be stored at room-temperature

Specific details on test material used for the study:

Name: FAT 20013/A
Purity: 59 %

Test animals / tissue source

Species:

rabbit

Test system

Vehicle:

water

Controls:

not required

Amount / concentration applied:

70 mg of FAT 20013/A was instilled into each eye.

Duration of treatment / exposure:

The eyes are examined and the grade of ocular reaction is recorded at 24, 48 and 72 hours.

Observation period (in vivo):

24 hours

Number of animals or in vitro replicates:

Six albino rabbits are used for each test substance.

Details on study design:

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

Basis:

mean

Remarks:

6 animals

Time point:

24/48/72 h

Score:

0.05

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

6 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

Basis:

mean

Time point:

24/48/72 h

Score:

0.46

Max. score:

3

Reversibility:

fully reversible within: 7 days

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

6 animals

Time point:

24/48/72 h

Score:

0.46

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

One animal only gave a "positive" reaction. A temporary corneal opacity was observed in this one animal 24 hours after instillation only. A slight dulling of the normal corneal lustre was observed in one other animal 24 hours after instillation only. Mild conjunctival reactions were observed in all six animals. A maximum group mean reaction of 6 was established on day 1.

Any other information on results incl. tables

Numerical Scores awarded to the ocular reactions elicited by FAT 20013/A:

Animal Number	Region of eye		Day
			1	2	3	4	7	14	21
1	Cornea		0	0	0	0	0	0	0
	Iris		0	0	0	0	0	0	0
	Conjuctivae		4	0	0	0	0	0	0
	TOTAL		4	0	0	0	0	0	0
2	Cornea		0	0	0	0	0	0	0
	Iris		0	0	0	0	0	0	0
	Conjuctivae		6	0	0	0	0	0	0
	TOTAL		6	0	0	0	0	0	0
3	Cornea		0	0	0	0	0	0	0
	Iris		0	0	0	0	0	0	0
	Conjuctivae		2	2	0	0	0	0	0
	TOTAL		2	2	0	0	0	0	0
4	Cornea		5	0	0	0	0	0	0
	Iris		0	0	0	0	0	0	0
	Conjuctivae		6	4	2	2	2	2	0
	TOTAL		11	4	2	2	2	2	0
5	Cornea		0	0	0	0	0	0	0
	Iris		0	0	0	0	0	0	0
	Conjuctivae		6	2	0	0	0	0	0
	TOTAL		6	2	0	0	0	0	0
6	Cornea		0	0	0	0	0	0	0
	Iris		0	0	0	0	0	0	0
	Conjuctivae		8	2	2	0	0	0	0
	TOTAL		8	2	2	0	0	0	0
Total Score			37	16	4	2	2	2	0
Mean / rabbit			6	3	<1	<1	<1	<1	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 20013/A is considered to be a non-irritant to the eyes.

Executive summary:

In a study performed according to The Food and Drugs Administration of the U.S.A. in The Federal Register (17 September 1964 S 191.12), to determine the eye irritation potential of FAT 20013A, the test substance was instilled in the eyes of 3 male and 3 female rabbits and observations for irritation were recorded at the time points of 1 hour, 6 hours, 1 day, 2 days, 3 days, 4 days, 7 days, 14 days and 21 days. Corneal opacity, Iris, Conjuctivae and chemosis score was reported to be 0.05, 0, 0.46, 0.46 respectively, indicating a very weak irritation potential. One animal only gave a "positive" reaction. A temporary corneal opacity was observed in this one animal 24 hours after instillation only. A slight dulling of the normal corneal lustre was observed in one other animal 24 hours after instillation only. Mild conjunctival reactions were observed in all six animals. A maximum group mean reaction of 6 was established on day 1. Based on these findings, FAT 20013/A is considered to be a non-irritant to the eyes.