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Toxicological information

Eye irritation

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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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
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
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
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.