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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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
Qualifier:
according to guideline
Guideline:
other: The procedure employed was that prescribed by The Food and Drug Administration of the U.S.A. in The Federal Register (17 September 1964 * 191.12), a transcript of which is attached as Appendix I to this report.
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)]-, disodium
EC Number:
260-394-7
EC Name:
Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)]-, disodium
Cas Number:
56819-40-0
Molecular formula:
C32H21CrN10O11S.2Na
IUPAC Name:
Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)]-, disodium
Details on test material:
None
Specific details on test material used for the study:
Name: FAT 20010/A
Purity: 57 %

Test animals / tissue source

Species:
rabbit

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
Not available
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
six animals
Details on study design:
SCORING SYSTEM:
CORNEA
Opacity: degree of density (area most dense taken for reading).
- No ulceration or opacity:...................................................................................................................................... 0
- Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible:................ 1
- Easily discernible translucent area, details of iris slightly obscured:......................................................................... 2
- Nacrous area, no details of iris visible, size of pupil barely discernible:..................................................................... 3
- Opaque cornea, iris not discernible through the opacity:......................................................................................... 4

IRIS
- Normal:............................................................................................................................................................... 0
- Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any 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

CONJUNCTIVAE
Redness: (refers to palpebral and bulbar conjunctivae, cornea and iris)
- Blood vessels normal:............................................................................... 0
- Some blood vessels definitely hyperaemic (injected):................................... 1
- Diffuse, crimson colour, individual vessels not easily discernible:................... 2
- Diffuse, beefy red:..................................................................................... 3

Chemosis: lids and/or nictitating membranes
- No swelling..................................................................................... 0
- Any swelling above normal (includes nictitating membranes)............... 1
- Obvious swelling with partial eversion of lids....................................... 2
- Swelling with lids about half closed.................................................... 3
- Swelling with lids more than, half closed............................................. 4

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:
0.277
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
iris score
Basis:
mean
Remarks:
6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
6 animals
Time point:
24/48/72 h
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 animals
Time point:
24/48/72 h
Score:
0.61
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
Two animals gave "positive" reactions. Temporary corneal opacities developed in these two animals. A temporary dulling of the normal corneal lustre was observed in one other animal.
A diffuse crimson-red colouration of the conjunctivae was observed in one of these animals and considerable swelling of the conjunctivae with partial eversion of the eyelids in two animals. Mild conjunctival reactions were observed in the four remaining animals.

Any other information on results incl. tables

Numerical scores awarded to the ocular reactions eleicited by FAT 20010/A

Animal Number Region of eye Day
1 2 3 4 7 14 21
1 Cornea 0 5 0 0 0 0 0
Iris 0 0 0 0 0 0 0
Conjuctivae 10 6 0 0 0 0 0
Total 10 11 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 0 0 0 0 0 0
Total 2 0 0 0 0 0 0
4 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
5 Cornea 15 5 0 0 0 0 0
Iris 0 0 0 0 0 0 0
Conjuctivae 12 8 4 4 2 0 0
Total 27 13 4 4 2 0 0
6 Cornea D D 0 0 0 0 0
Iris 0 0 0 0 0 0 0
Conjuctivae 4 2 0 0 0 0 0
Total 4 2 0 0 0 0 0
Total Score 55 26 4 4 2 0 0
Mean Rabbit 9 4 <1 <1 <1 0 0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 20010/A is considered to be non-irritant to the rabbit eye.
Executive summary:

In a study performed as prescribed by The Food and Drug Administration of the U.S.A. in The Federal Register (17 September 1964 * 191.12) exposing six rabbit eyes to FAT 20010 and observed for 7 days. The ocular reactions were scored by the method described by J. H. Draize in "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" p 51. Two animals gave "positive" reactions. Temporary corneal opacities developed in these two animals. A temporary dulling of the normal corneal lustre was observed in one other animal. A diffuse crimson-red colouration of the conjunctivae was observed in one of these animals and considerable swelling of the conjunctivae with partial eversion of the eyelids in two animals. Mild conjunctival reactions were observed in the four remaining animals. Based on the results, FAT 20010/A is considered to be non-irritant to the rabbit eye.