[No public or meaningful name is available]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

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

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

not specified

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of disodium 1-amino-4-[[3-[(2,3-dibromo-1-oxopropyl)amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate and disodium 1-amino-4-[[3-[(2-bromo-1-oxoallyl)amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Molecular formula:

C26H20.85Br1.82Na1.97N3O9S2

IUPAC Name:

Reaction mass of disodium 1-amino-4-[[3-[(2,3-dibromo-1-oxopropyl)amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate and disodium 1-amino-4-[[3-[(2-bromo-1-oxoallyl)amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Test material form:

not specified

Details on test material:

None

Test animals / tissue source

Species:

rabbit

Strain:

other: Russian breed

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Housing: V2A wire cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 g of the test substance

Duration of treatment / exposure:

One application

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6 rabbits (3 males and 3 females)

Details on study design:

Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. After application, the eyelids were held open for a few seconds. The right eye served as a control. The treated eyes of three rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment.

The reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days on the basis of the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO.

SCORING SYSTEM:
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
Total maximum = 80 (A x B x 5)

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, hemorrhage, gross destruction (any or all of these): 2
A x 5

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
(A + B + C) x 2 Total maximum = 20

The total maximum is 80 for the cornea, 10 for the iris and 20 for the conjunctivae.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

3 females (eyes rinsed)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #4

Remarks:

eyes not rinsed

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not specified

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #5

Remarks:

eyes not rinsed

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72h

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #6

Remarks:

eyes not rinsed

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not specified

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

eyes rinsed

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 72h

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #2

Remarks:

eyes rinsed

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 72h

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

eyes rinsed

Time point:

24/48/72 h

Score:

1.67

Max. score:

3

Reversibility:

fully reversible within: 72h

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #4

Remarks:

eyes not rinsed

Time point:

24/48/72 h

Score:

2.33

Max. score:

3

Reversibility:

not fully reversible within: 7d

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #5

Remarks:

eyes not rinsed

Time point:

24/48/72 h

Score:

2.33

Max. score:

3

Reversibility:

fully reversible within: 7d

Results 10

Irritation parameter:

conjunctivae score

Basis:

animal #6

Remarks:

eyes not rinsed

Time point:

24/48/72 h

Score:

2.33

Max. score:

3

Reversibility:

fully reversible within: 7d

Results 11

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

eyes rinsed

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 12

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

eyes rinsed

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 72h

Results 13

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

eyes rinsed

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 72h

Results 14

Irritation parameter:

chemosis score

Basis:

animal #4

Remarks:

eyes not rinsed

Time point:

24/48/72 h

Score:

2.67

Max. score:

4

Reversibility:

not fully reversible within: 7d

Results 15

Irritation parameter:

chemosis score

Basis:

animal #5

Remarks:

eyes not rinsed

Time point:

24/48/72 h

Score:

2.67

Max. score:

4

Reversibility:

fully reversible within: 7d

Results 16

Irritation parameter:

chemosis score

Basis:

animal #6

Remarks:

eyes not rinsed

Time point:

24/48/72 h

Score:

2.67

Max. score:

4

Reversibility:

fully reversible within: 7d

Results 17

Irritation parameter:

iris score

Basis:

mean

Remarks:

3 female eyes rinsed and 3 female eyes not rinsed

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The results of the eye irritation test are summarized in tables 1 and 2. The total maximum is 80 for the cornea, 10 for the iris and 20 for the conjunctivae. The irritation index was found to be 10.8 for the cornea, 0 for the iris and 6.9 for the conjunctivae.

Any other information on results incl. tables

Eyes rinsed:

Days after application	Rabbit 1 Female			Rabbit 2 Female			Rabbit 3 Female
	Cornea	Iris	Conjuct.	Cornea	Iris	Conjuct.	Cornea	Iris	Conjuct.
1	0	0	10	0	0	10	0	0	12
2	0	0	6	0	0	10	0	0	10
3	0	0	0	0	0	0	0	0	0
4	0	0	0	0	0	0	0	0	0
7	0	0	0	0	0	0	0	0	0

Eyes not rinsed:

Days after application	Rabbit 4 Male			Rabbit 5 Male			Rabbit 6 Male
	Cornea	Iris	Conjuct.	Cornea	Iris	Conjuct.	Cornea	Iris	Conjuct.
1	20	0	18	10	0	16	30	0	18
2	30	0	12	5	0	12	45	0	12
3	40	0	12	0	0	10	45	0	10
4	30	0	8	0	0	6	40	0	6
7	20	0	8	0	0	0	10	0	0

Data represent values of calculated primary eye irritation index. Eyes not rinsed should not be taken into account for the overall hazard assessment.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 40069/A is to be considered as a non-irritant to the eye of rabbits.

Executive summary:

A study was performed to determine the eye irritation potential of FAT 40069/A on rabbits according to the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). The substance was tested on 6 rabbits (3 males/3 females) of the Russian breed and only rabbits showing normal ophthalmic findings were included in the test. Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. After application, the eyelids were held open for a few seconds. The right eye served as a control. The treated eyes of three rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment. The reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days. The primary-irritation index, which serves as a measure of the acute irritation provoked by the substance, was found to be 10.8 for the cornea, 0 for the iris and 6 .9 for the conjunctivae. The effects were observed to be completely reversible by the end of Day 7. FAT 40069/A is to be considered as a non-irritant to the eye of rabbits.