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Registration Dossier
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EC number: 215-397-8 | CAS number: 1325-54-8 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 40215.
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:
- 1993
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-nitro-, disodium salt, reaction products with 4-[(4-aminophenyl)azo]benzenesulfonic acid, sodium salts
- EC Number:
- 215-397-8
- EC Name:
- Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-nitro-, disodium salt, reaction products with 4-[(4-aminophenyl)azo]benzenesulfonic acid, sodium salts
- Cas Number:
- 1325-54-8
- Molecular formula:
- Molecular formula of the main constituents: (1) C38H24N8Na4O12S4 (2) C52H32N10Na6O18S6
- IUPAC Name:
- decasodium 2-[(1E)-2-{2-sulfonato-4-[(1E)-2-{3-sulfonato-4-[(1E)-2-{2-sulfonato-4-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]phenyl}ethenyl]phenyl}diazen-1-yl]phenyl}ethenyl]-5-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]benzene-1-sulfonate 2-[(1E)-2-{2-sulfonato-4-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]phenyl}ethenyl]-5-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]benzene-1-sulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Lot/batch No.: 623
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GMBH; Chemisch-pharmazeutische Fabrik D-7950 Biberach/Riss
- Age at study initiation:
- Weight at study initiation: 2230 to 2620 g
- Housing: individually
- Diet (e.g. ad libitum): libitum standard rabbit pellet
- Water (e.g. ad libitum): fresh water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +-3°C
- Humidity (%): 30-70%
- Air changes (per hr): Unknown
- Photoperiod (hrs dark / hrs light): 12 hours light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml (32 mg) of FAT 11030/B were applied into the conjunctival sac of the left eye of each animal.
- The right eye remained untreated and served as control - Duration of treatment / exposure:
- After instillation the lids were held together for about on second to prevent loss of the test article.
- Observation period (in vivo):
- Ocular reaction were evaluated after 1, 24, 48 and 72 hours after instillation
Reaction was observed after 7, 10 and 14 days of the instillation - Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM:
Cornea
A.- Opacity-degree of density
No opacitiy 0
Scaterred or difussed area, details of iris clearly visible 1
Easily discernible translucent areas, details of iris slightly obscured 2
Opalescent areas, no details of iris visible 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
Iris
A.- Values
Normal 0
Folds above normal, congestion, swelling, circumcorneal injection 1
No reaction to light, hemorrhage, gross destruction 2
Ax5 Total maximum=10
Conjuctivae
A.- Redness
Vessels normal 0
Vessels definitely injected above normal 1
More diffuse, deeper crimson red, individual vessels not 2
easily discernible
Diffuse beefy red 3
B.- Chemosis
No swelling 0
Any swelling above normal 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 1
Discharge with moistening of the lids and hairs just adjacent to lids 2
Discharge with moistening of the lids and hairs, and considerable 3
area around the eye
(A+B+C)x2 Total maximum=20
TOOL USED TO ASSESS SCORE: A slit-lamp was used to facilitate the evaluation .
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- 658/F
- Time point:
- other: 24-72 hours
- Score:
- > 0 - < 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- 658/F
- Time point:
- other: 24-72
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Remarks:
- 658/F
- Time point:
- other: 24-72 hours
- Score:
- > 0 - < 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- 658/F
- Time point:
- other: 24-72 hours
- Score:
- > 0 - < 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- 110/F
- Time point:
- other: 24-72 hours
- Score:
- > 0 - < 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- 110/F
- Time point:
- other: 24-72 hours
- Score:
- > 0 - < 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Remarks:
- 110/F
- Time point:
- other: 24-72 hours
- Score:
- > 0 - < 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- 110/F
- Time point:
- other: 24-72 hours
- Score:
- > 0 - < 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- 098/F
- Time point:
- other: 24-72 hours
- Score:
- > 0 - < 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- 098/F
- Time point:
- other: 24-72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Remarks:
- 098/F
- Time point:
- other: 24-72 hours
- Score:
- > 0 - < 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- 098/F
- Time point:
- other: 24-72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 14 days
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the EEC classification of the results obtained 24 to 72 hours after instillation of the substance, it can be classified as non-irritant to albino rabbit's eye. Changes fully reversible within 14 days.
- Executive summary:
Under the experimental conditions employed the test material induced reactions of the cornea, iris and conjunctiva when instilled into the conjunctival sac of albino rabbits' eyes.
The following mean scores (24 - 72h) were calculated:
Animal No 658 110 098 Conjunctiva/redness 1 2 1 Conjunctiva /chemosis 0.33 0.33 0 Cornea 0.33 0.67 0.33 Iris 0 0.33 0
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