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EC number: 274-436-7 | CAS number: 70210-39-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1974
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
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: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).
- Deviations:
- yes
- Remarks:
- not rinsing treated eyes represents an elevated testing condition compared to today's standard guidelines
- GLP compliance:
- no
Test material
- Reference substance name:
- Disodium 5-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]azo]-4-hydroxy-6-(methylamino)naphthalene-2-sulphonate
- EC Number:
- 274-436-7
- EC Name:
- Disodium 5-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]azo]-4-hydroxy-6-(methylamino)naphthalene-2-sulphonate
- Cas Number:
- 70210-39-8
- Molecular formula:
- C20H17BrN4O8S2.2Na
- IUPAC Name:
- disodium 5-({4-[(2-bromoacryloyl)amino]-2-sulfonatophenyl}diazenyl)-4-hydroxy-6-(methylamino)naphthalene-2-sulfonate
- Test material form:
- not specified
- Details on test material:
- No data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Russian breed
- Housing: Housed separately in V2A wire cages
- Diet: NAFAG, Gossau SG, rabbit food ad libitum
- Water: ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated right eye served as a control
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- 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 female rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment.
- Observation period (in vivo):
- After exposure the reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days.
- Number of animals or in vitro replicates:
- 6 rabbits (3 male and 3 female)
- 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.
- Time after start of exposure: about 30 seconds after treatment.
SCORING SYSTEM: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO.
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- Rinsed and not rinsed
- Basis:
- mean
- Remarks:
- Six rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- Rinsed and not rinsed
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Eyes rinsed
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #4
- Remarks:
- Eyes not rinsed
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- Eyes not rinsed
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #4
- Remarks:
- Eyes not rinsed
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Remarks:
- Eyes not rinsed
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #5
- Remarks:
- Eyes not rinsed
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- Eyes not rinsed
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #5
- Remarks:
- Eyes not rinsed
- Time point:
- 48 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- Eyes not rinsed
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- Eyes not rinsed
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #6
- Remarks:
- Eyes not rinsed
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- Eyes not rinsed
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #6
- Remarks:
- Eyes not rinsed
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- Eyes not rinsed
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #6
- Remarks:
- Eyes not rinsed
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- Eyes not rinsed
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The irritation index was found to be 1.3 for the conjunctival scores that have been fully reversible within 48 hours. In addition, it has to be mentioned that not rinsing treated eyes represents an elevated testing condition compared to today's standard guidelines. Remaining test material may cause continuous mechanical irritation and therefore altering the response to the chemical.
- Other effects:
- None observed
Any other information on results incl. tables
The total maximum score is 80 for the cornea, 10 for the iris and 20 for the conjunctivae. The irritation index was found to be 0 for the cornea, 0 for the iris and 1.3 for the conjunctivae.
Individual animal score: eyes rinsed
Days after application | Rabbit 1 | Rabbit 2 | Rabbit 3 | ||||||
Cornea | Iris | Conjunctivae | Cornea | Iris | Conjunctivae | Cornea | Iris | Conjunctivae | |
1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Individual animal score: eyes not rinsed
Days after Application | Rabbit 4 | Rabbit 5 | Rabbit 6 | ||||||
Cornea | Iris | Conjunctivae | Cornea | Iris | Conjunctivae | Cornea | Iris | Conjunctivae | |
1 | 0 | 0 | 8 | 0 | 0 | 12 | 0 | 0 | 6 |
2 | 0 | 0 | 0 | 0 | 0 | 8 | 0 | 0 | 6 |
3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 40063/A is to be considered as a minimal irritant to the eye of rabbits.
- Executive summary:
FAT 40063/A was subjected to eye irritation test according to the procedure adopted 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). The substance was tested on 6 rabbits (3 males/3 females) of the Russian breed. 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.
The primary-irritation index, which serves as a measure of the acute irritation provoked by the substance, was found to be 0 for the cornea, 0 for the iris and 0.0 for the conjunctivae in case of rinsed eyes. Therefore, FAT 40063/A is to be considered as a non-irritant to the eye of rabbits.
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