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EC number: 274-040-4 | CAS number: 69563-51-5
- 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:
- 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthryl)benzenesulphonamide
- EC Number:
- 274-040-4
- EC Name:
- N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthryl)benzenesulphonamide
- Cas Number:
- 69563-51-5
- Molecular formula:
- C21H16N2O5S
- IUPAC Name:
- N-(4-amino-3-methoxy-9,10-dioxo-9,10-dihydroanthracen-1-yl)benzenesulfonamide
- Test material form:
- other: solid
- Details on test material:
- None
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 9300102
- Expiration date of the lot/batch: July, 1998
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
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
- Weight at study initiation: between 2220 to 2490 g
- Housing: The animals were housed individually in metal cages.
- Diet (e.g. ad libitum):The rabbits received ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water (e.g. ad libitum):Fresh water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):20 ± 3
- Humidity (%):30-70
- Photoperiod (hrs dark / hrs light):12 hours light cycle day.
Test system
- Vehicle:
- water
- Controls:
- other: The right eye remained untreated and served as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml (46 mg) - Duration of treatment / exposure:
- The test substance was not flushed out of the eye.
- Observation period (in vivo):
- 1, 24, 48, and 72 hours
- Number of animals or in vitro replicates:
- 3 female rabbits
- Details on study design:
- Method
0.1 ml (46 mg) of FAT 36034/D was placed into the conjunctival sac of the left eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test article.
The right eye remained untreated and served as a control. The animals were checked daily for systemic symptoms and mortality (only findings reported).
The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of FAT 36034/D according to the OECD scoring system (Appendix 1). In order to determine the reversibility of the eye reactions additional evaluations of the ocular reactions were needed in this study. A slit-lamp was used to facilitate the evaluation. The irritant/corrosive potency of FAT 36034/D was classified according to Council Directive 67/548/EEC, adapted to technical progress by Commission Directive 93/21/EEC
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Because reactions were observed within 72 hours after instillation of the test article , the observation period was extended to 7 days to determine the reversibility of the eye reactions.
Individual eye scores
Animal No 002/F
Time point |
Cornea (ce/te) |
Iris (ce/te) |
Conjunctiva |
|
Redness (ce/te) |
Chemosis (ce/te) |
|||
After 24 hours |
0/0 |
0/0 |
0/0 |
0/0 |
After 48 hours |
0/0 |
0/0 |
0/1 |
0/0 |
After 72 hours |
0/0 |
0/0 |
0/1 |
0/0 |
Mean (24-72 Hrs) |
0/0 |
0/0 |
0/0.67 |
0/0 |
Animal No 092/F
Time point |
Cornea (ce/te) |
Iris (ce/te) |
Conjunctiva |
|
Redness (ce/te) |
Chemosis (ce/te) |
|||
After 24 hours |
0/0 |
0/0 |
0/1 |
0/0 |
After 48 hours |
0/0 |
0/0 |
0/1 |
0/0 |
After 72 hours |
0/0 |
0/0 |
0/1 |
0/0 |
Mean (24-72 Hrs) |
0/0 |
0/0 |
0/1 |
0/0 |
Animal No 040/F
Time point |
Cornea (ce/te) |
Iris (ce/te) |
Conjunctiva |
|
Redness (ce/te) |
Chemosis (ce/te) |
|||
After 24 hours |
0/0 |
0/1 |
0/1 |
0/0 |
After 48 hours |
0/0 |
0/0 |
0/1 |
0/0 |
After 72 hours |
0/0 |
0/0 |
0/1 |
0/0 |
Mean (24-72 Hrs) |
0/0 |
0/0.33 |
0/1 |
0/0 |
ce = control eye
te = test eye
Reversibility of any observed effect: Changes fully reversible within 7 days.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 36034/D can be classified as non-irritant.
- Executive summary:
An acute eye irritation/corrosion key study was performed in NZW rabbits to determine the irritant or corrosive potency of FAT 36034/D on the NZW rabbit eye and the associated mucous membranes. This test was based on the OECD guideline No. 405, adopted May 12, 1981, by the OECD council and as well as followed the GLP guidelines. The substance was tested at the concentration of 94% purity. Under the experimental conditions applied FAT 36034/D induced reactions of the cornea, iris and conjunctiva when instilled into the conjunctival sac of albino rabbit eyes. Because the mean values (0.89 for conjunctiva/redness; and 0.11 for iris) of the readings 24 to 72 hours after instillation are below the threshold of significance, FAT 36034/D can be classified as non-irritant according to Council Directive 67/548/EEC, adapted to technical progress by Commission Directive 93/21/EEC.
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