Disodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxybenzenesulphonato(3-)][1-[[2-hydroxy-5-(phenylazo)phenyl]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:

1975

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:

1975

Report date:

1975

Materials and methods

Test guideline

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 Cosmetic (1959) of the US Association of Food and Drug Officials (AFDO).

Deviations:

not specified

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Disodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxybenzenesulphonato(3-)][1-[[2-hydroxy-5-(phenylazo)phenyl]azo]-2-naphtholato(2-)]chromate(2-)

EC Number:

258-027-0

EC Name:

Disodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxybenzenesulphonato(3-)][1-[[2-hydroxy-5-(phenylazo)phenyl]azo]-2-naphtholato(2-)]chromate(2-)

Cas Number:

52587-68-5

Molecular formula:

C38H25CrN8O7S.2Na

IUPAC Name:

Disodium [4-(hydroxy-kO)-3-{[5-(hydroxy-kO)-3-methyl-1-phenyl-1H-pyrazol-4-yl]diazenyl-kN1}benzenesulfonato(3-)][1-({2-(hydroxy-kO)-5-[phenyldiazenyl]phenyl}diazenyl-kN1)naphthalen-2-olato(2-)-kO]chromate(2-)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

None

Specific details on test material used for the study:

Identification:21095/A
Purity: 80 %

Test animals / tissue source

Species:

rabbit

Strain:

other: Russian breed

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Housing: Rabbits were kept separately in V2A wire-mesh cages
- Diet (e.g. ad libitum):Rabbits were fed on NAFAG, Gossau SG, rabbit food
- Water (e.g. ad libitum): ad libitum

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: Yes, right eye of rabbit served as control.

Amount / concentration applied:

0.1 g

Duration of treatment / exposure:

30 seconds

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6 rabbits (3 males and 3 females)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eyes of three rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment.
- Time after start of exposure: 24 hours

SCORING SYSTEM:
Evaluation of the Eye Reactions
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

A x B x 5 Total maximum = 80

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

Ax5

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


TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

iris score

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

other: Eyes rinsed

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: Eyes rinsed

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

1.11

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: Eyes rinsed

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

0.88

Max. score:

3

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: Eyes rinsed

Results 5

Irritation parameter:

iris score

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

other: Eyes not rinsed

Results 6

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

1.89

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: Eyes not rinsed

Results 7

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: Eyes not rinsed

Results 8

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

3 animals

Time point:

24/48/72 h

Score:

1.78

Max. score:

3

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: Eyes not rinsed

Irritant / corrosive response data:

The total maximum is 80 for the cornea, 10 for the iris and 20 for the conjunctivae.
The irritation index was found to be 7.8 for the cornea, 0 for the iris and 5.8 for the conjunctivae.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 21095/A is considered to be not irritating to rabbit eyes.

Executive summary:

FAT 21095/A was tested for eye irritation potential on rabbits eye. This test was conducted in accordance with "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO. The substance was tested on 6 rabbits (3 males/3 females) of the Russian breed. 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, they 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. In rinsed eyes, effects were observed on conjuctivae and cornea which were reversible within 7 days. Similar effects were observed in unrinsed eyes which were not reversible within 7 days. No effect on Iris was observed in both rinsed and unrinsed eye. Based on the findings of the study, FAT 21095/A is considered to be not irritating to rabbit eyes.