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EC number: 286-122-7 | CAS number: 85187-33-3
- 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:
- 27 April 1994 to 22 June 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: part B of Council Directive 79/831/EEC (Commission Directive 92/69/EEC of July 31, 1992
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Disodium 6-amino-5-[{4-[(2-bromoacryloyl)amino]-2-[(4-methyl-3-sulfonatophenyl)sulfonyl]phenyl}diazenyl]naphthalene-2-sulfonate
- Cas Number:
- 85187-33-3
- Molecular formula:
- C26H19BrN4Na2O9S3
- IUPAC Name:
- Disodium 6-amino-5-[{4-[(2-bromoacryloyl)amino]-2-[(4-methyl-3-sulfonatophenyl)sulfonyl]phenyl}diazenyl]naphthalene-2-sulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Identity - FAT 40066/E TE
Batch - SBL009/LR6G (India)
Appearance - brown powder, solid at 20 °C
Smell - neutral
pH-Value - pH-value of a soln. of 2% (w/w) = 5.2
Expiration date - December 18th, 2018
Storage - to be stored at room-temperature
Constituent 1
- Specific details on test material used for the study:
- - Source and lot/batch number of test material: P.04.36
- Expiration date of the lot/batch: 11/98
- Appearance: Solid
- Storage conditions: 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-88397 Biberach
- Weight at study initiation: 2050 to 2830 g.
- Housing: metal cages
- Diet:: standard rabbit pellet - Nafag No. 814, Gossau, Switzerland ad libitum
- 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:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.1 ml (82 mg) of FAT 40066/C was placed into the conjunctival sac of the left eye of each animal.
- Duration of treatment / exposure:
- The lids were then held together for about one second in order to prevent loss of the test article.
- Observation period (in vivo):
- 24, 48, and 72 h
- Number of animals or in vitro replicates:
- 3 (one female and two male rabbits)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 animal
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
Individual eye score:
Animal No. |
Time point |
Corneal opacity |
Iris |
Conjunctiva |
|
|
Redness |
Chemosis |
|||
1 |
After 24 h |
0 |
0 |
1 |
0 |
2 |
0 |
0 |
1 |
0 |
|
3 |
0 |
0 |
1 |
0 |
|
1 |
After 48 h |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
|
1 |
After 72 h |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 40066 is considered to be a non-irritant to the eyes.
- Executive summary:
In a study performed according to OECD guideline 405 to determine the eye irritation potential of FAT 40066/C, the test substance was instilled in the eyes of 1 male and 2 female rabbits and observations for irritation were recorded at the time points of 24 hours, 48 hours 72 hours. 0.1 ml (82 mg) of FAT 40066/C 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.
The corneal opacity, iiris and chemosis score was "0" while redness was seen in all animals at 24 h but get reversed within 48 h. There were no mortality or adverse effects were seen in the study.
Under the experimental conditions FAT 40066/C 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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