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EC number: 276-911-4 | CAS number: 72829-25-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- July 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Justification for type of information:
- Refer chapter 13 for the detailed analogue justification.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Refer chapter 13 for the detailed analogue justification.
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 rabbit
- Time point:
- 24 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- 48 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 rabbit
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0.83
- Max. score:
- 3
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- 24 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 rabbit
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 rabbit
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the read across data generated from the eye irritation study of Reactive Red 024, the target substance (Reactive Red 024:1) is also considered as non-irritant to the rabbit eyes.
- Executive summary:
Data on eye irritation study was not available for the target substance (Reactive Red 024:1). To fill the data gaps, read across approach is adapted using similar substance Reactive Red 024. A study performed to determine the eye irritation potential of FAT 40034/A in New Zealand White rabbits in accordance with the procedure set out in the "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965), with slight modification. 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 h, 6 h, 1 day, 2 days, 3 days, 6 days and 10 days. One hour after application of the test compound there was slight opacity and ulceration of the cornea in 3/6 animals (unwashed eyes) and a conjunctival reaction in 6/6. The corneal changes had healed by day 3 and the conjunctivae were normal, apart from slight injection of vessels in one animal, by day 6. Staining of the cornea was visible up to 48 h. Based on the read across data generated from the eye irritation study of Reactive Red 024, the target substance (Reactive Red 024:1) is also considered as non-irritant to the rabbit eyes.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965)
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- Trisodium 5-[[4-chloro-6-(methylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate
- EC Number:
- 274-417-3
- EC Name:
- Trisodium 5-[[4-chloro-6-(methylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate
- Cas Number:
- 70210-20-7
- Molecular formula:
- C26H20ClN7O10S3.3Na
- IUPAC Name:
- trisodium 5-({4-chloro-6-[methyl(phenyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(2-sulfonatophenyl)diazenyl]naphthalene-2,7-disulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- FAT 40034/B
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Animals:
Healthy New Zealand White rabbits (Porton strain) aged 10-15 weeks with average body weights of 2.65 kg (Males) and 2.53 kg (Females), bred on the premises and maintained under a semi-barrier system. Six rabbits (3 males and 3 females) were acclimatised in the test area for one week prior to the start of the trial.
Husbandry:
The rabbits were caged singly in an experimental room maintained at a temperature of 20 °C. (±1°) and a relative humidity of 50-70 %. Animals were exposed to artificial light for 10 hours daily from 08.00 - 18.00 h. A commercial irradiated diet (Styles-Oxoid) was fed ad lib. Sterile filtered water was available at all times.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 100 mg of the test compound (equivalent to 0.1 ml in volume) was applied.
- Duration of treatment / exposure:
- 30 seconds
- Observation period (in vivo):
- The rabbits were examined 1, 6, 24, 48 and 72 h after application of the test compound and for any further period that was considered necessary.
- Number of animals or in vitro replicates:
- 3 males and 3 females
- Details on study design:
- The eyes of the experimental animals were examined and found normal prior to the test. 100 mg of the test compound (equivalent to 0.1 ml in volume) were instilled into the conjunctival sac of the left eye. The eyelids were then held closed for 1 second. The right eye served as a control. After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with 30 ml of warm water. The rabbits were examined 1, 6, 24, 48 and 72 h after application of the test compound and for any further period that was considered necessary. The ocular reactions were scored by the method described in "Appraisal of the Safety of Chemicals in Food Drugs and Cosmetics", published by the Association of Food and Drug Officials of the UCS.A.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 rabbit
- Time point:
- 24 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- 48 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 rabbit
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0.83
- Max. score:
- 3
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- 24 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 rabbit
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 rabbit
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
Evaluation of the Eye Reactions: Individual animal score
Cornea
Animal No |
Observation time (Hr) |
Degree of intensity |
Area of cornea involved |
Rabbit 11 |
24 |
1 |
1 |
48 |
1 |
1 |
|
72 |
0 |
0 |
|
Rabbit 13 |
24 |
0 |
0 |
48 |
0 |
0 |
|
72 |
0 |
0 |
|
Rabbit 15 |
24 |
0 |
0 |
48 |
0 |
0 |
|
72 |
0 |
0 |
|
Rabbit 12 |
24 |
1 |
1 |
48 |
0 |
0 |
|
72 |
0 |
0 |
|
Rabbit 14 |
24 |
0 |
0 |
48 |
0 |
0 |
|
72 |
0 |
0 |
|
Rabbit 16 |
24 |
0 |
0 |
48 |
0 |
0 |
|
72 |
0 |
0 |
Iris
Animal No |
Observation time (Hr) |
Score |
Rabbit 11 |
24 |
0 |
48 |
0 |
|
72 |
0 |
|
Rabbit 13 |
24 |
0 |
48 |
0 |
|
72 |
0 |
|
Rabbit 15 |
24 |
0 |
48 |
0 |
|
72 |
0 |
|
Rabbit 12 |
24 |
0 |
48 |
0 |
|
72 |
0 |
|
Rabbit 14 |
24 |
0 |
48 |
0 |
|
72 |
0 |
|
Rabbit 16 |
24 |
0 |
48 |
0 |
|
72 |
0 |
Conjunctiva
Animal No |
Observation time (Hr) |
Redness |
Chemosis |
Discharge |
Rabbit 11 |
24 |
1 |
0 |
2 |
48 |
1 |
0 |
0 |
|
72 |
1 |
0 |
0 |
|
Rabbit 13 |
24 |
1 |
1 |
0 |
48 |
1 |
0 |
0 |
|
72 |
1 |
0 |
0 |
|
Rabbit 15 |
24 |
0 |
0 |
0 |
48 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
|
Rabbit 12 |
24 |
2 |
1 |
0 |
48 |
2 |
0 |
0 |
|
72 |
1 |
0 |
0 |
|
Rabbit 14 |
24 |
1 |
0 |
0 |
48 |
1 |
0 |
0 |
|
72 |
1 |
0 |
0 |
|
Rabbit 16 |
24 |
0 |
0 |
0 |
48 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 40034/A is considered as non-irritant to the rabbit eyes.
- Executive summary:
A study performed to determine the eye irritation potential of FAT 40034/A in New Zealand White rabbits in accordance with the procedure set out in the "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965), with slight modification. 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 h, 6 h, 1 day, 2 days, 3 days, 6 days and 10 days. One hour after application of the test compound there was slight opacity and ulceration of the cornea in 3/6 animals (unwashed eyes) and a conjunctival reaction in 6/6. The corneal changes had healed by day 3 and the conjunctivae were normal, apart from slight injection of vessels in one animal, by day 6. Staining of the cornea was visible up to 48 h. Based on the study results, FAT 40034/A is considered to be a non-irritant to the eyes.
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