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EC number: 247-269-2 | CAS number: 25797-81-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981
- 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:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- FAT 20033/L TE
- IUPAC Name:
- FAT 20033/L TE
- Reference substance name:
- Sodium 1-amino-9,10-dihydro-4-[5-[(2-hydroxyethyl)sulphamoyl]-3,4-xylidino]-9,10-dioxoanthracene-2-sulphonate
- EC Number:
- 247-269-2
- EC Name:
- Sodium 1-amino-9,10-dihydro-4-[5-[(2-hydroxyethyl)sulphamoyl]-3,4-xylidino]-9,10-dioxoanthracene-2-sulphonate
- Cas Number:
- 25797-81-3
- Molecular formula:
- C24H23N3O8S2.Na
- IUPAC Name:
- sodium 1-amino-4-({3-[(2-hydroxyethyl)sulfamoyl]-4,5-dimethylphenyl}amino)-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- powder / dark blue
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: EN 01451.12
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2 to 3 kg
- Housing: The animals were housed individually in metal cages
- Diet: Standard rabbit food - NAFAG, No. 814, Gossau SG (ad libitum)
- Water: ad libitum
- Acclimation period: 4 d
ENVIRONMENTAL CONDITIONS
- Temperature: 22±2 °C
- Humidity: 55±10 %
- Photoperiod (dark / light): 12 h/12 h
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the second eye on the treated animals served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 100 mg
- Concentration (if solution): Undiluted - Duration of treatment / exposure:
- Unwashed eye: Duration of treatment same as observation period.
Washed eye: 30 seconds - Observation period (in vivo):
- 7 d
- Number of animals or in vitro replicates:
- 6 (3 males and 3 females)
- Details on study design:
- PROCEDURE:
- Only rabbits with normal ophthalmic findings were used for the test.
- The test substance in an amount of 100 mg was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control.
- In 3 of the 6 rabbits approx. 30 seconds after treatment the treated eye was flushed with 10 mL of physiological saline.
- The eye irritation was evaluated with a slit-lamp on 1, 2, 3, 4 and 7 d and was scored for each individual rabbit.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with 10 ml of physiological saline
- Time after start of exposure: 30 sec
SCORING SYSTEM:
CORNEA
A: Opacity and degree of density (most dense area scored)
0 - No opacity
1 - Scattered or diffuse area, details of iris clearly visible
2 - Easily discernible translucent areas, details of iris slightly obscured 2
3 - Opalescent areas, no details of iris visible, size of pupil barely discernible 3
4 - Opaque, iris invisible
B: Area of cornea involved
1 - One quarter (or less) but not zero
2 - Greater than one quarter, but less than half
3 - Greater than half, but less than three quarters
4 - Greater than three quarters, up to whole area
A x B x 5 Maximum possible score = 80
IRIS
A: Values
0 - Normal
1 - Folds above normal, congestion, swelling, circumcornea injection (any or all of these or combination of any thereof) iris still reacting to light (sluggish reaction is positive)
2 - No reaction to light, hemorrhage, gross destruction (any or all of these)
A x 5 Maximum possible score = 10
CONJUNCTIVAE
A: Redness (refers to palpebral and bulbar conjunctiva excluding cornea and iris)
0 - Vessels normal
1 - Vessels definitely injected above normal
2 - More diffuse, deeper crimson red, individual vessels not easily discernible
3 - Diffuse beefy red
B: Chemosis
0 - No swelling
1 - Any swelling above normal (includes nictitating membrane)
2 - Obvious swelling with partial eversion of lids
3 - Swelling with lids about half closed
4 - Swelling with lids about half closed to completely closed
C Discharge
0 - No discharge 0
1 - Any amount different from normal (does not include small amounts observed in inner canthus of normal animals)
2 - Discharge with moistening of the lids and hairs just adjacent to lids
3 - Discharge with moistening of the lids and hairs, and considerable area around the eye
(A + B + C) x 2 Maximum possible score = 20
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 d
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: Test substance was washed after 30 seconds of application
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: Test substance was washed after 30 seconds of application (however, observation period was up to 7 d only)
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: Test substance was washed after 30 seconds of application
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Test substance was washed after 30 seconds of application.
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7d
- Remarks on result:
- other: Test substance was washed after 30 seconds of application (however, observation period was up to 7 d only)
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Test substance was washed after 30 seconds of application.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritant / corrosive response data:
- The test substance was found to cause a minimal irritation (i.e., primary irritation index 5.7) when applied to the rabbit eye mucosa. When the application site was rinsed, the irritation was found to be minimal (i.e., primary irritation index 0.7).
- Other effects:
- none
Any other information on results incl. tables
Calculation of the primary eye irritation index:
| MEAN REACTION SCORE | |||||
Time after exposure (d) | Unrinsed eyes (A) | Rinsed eyes (B) | ||||
cornea | iris |
conjunctiva | cornea | iris |
conjunctiva | |
1 | 0 | 0 | 8 | 0 | 0 | 1.3 |
2 | 0 | 0 | 6.7 | 0 | 0 | 1.3 |
3 | 0 | 0 | 5.3 | 0 | 0 | 0.7 |
4 | 0 | 0 | 5.3 | 0 | 0 | 0 |
7 | 0 | 0 | 3.3 | 0 | 0 | 0 |
subtotal | 0 | 0 | 28.6 | 0 | 0 | 3.3 |
total | 28.6 | 3.3 |
Primary irritation index in unrinsed eyes:
A = 28.6 : 5 = 5.7
Primary irritation index in rinsed eyes:
B = 3.3 : 5 = 0.7
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance produced only slight conjunctival reaction.
- Executive summary:
An in vivo study was conducted to evaluate the acute eye irritation potential of the test substance (of ca. 82.2% purity) according to a procedure similar to OECD Guideline 405 with few deviations. 100 mg of the test substance was placed into the conjunctival sac of the left eye of rabbits (4 male and 2 females). The right eye remained untreated and was used as untreated control. In three rabbits washing was done with 10 mL of physiological saline after 30 seconds of test substance instillation. Assessment of ocular damage/irritation was made with a slit-lamp approximately on 1, 2, 3, 4 and 7 d following treatment. No corneal or iridial effects were noted during the study. Minimal irritation was observed with primary irritation index of 5.7 and 0.7 for rinsed and unrinsed eyes respectively. Under the study conditions, the test substance produced only slight conjunctival reaction.
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