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EC number: 228-783-6 | CAS number: 6358-69-6
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Justification for type of information:
- data is from experimental reportss
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To assess the eye irritation potential of the test chemical in rabbits
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Trisodium 8-hydroxypyrene-1,3,6-trisulphonate
- EC Number:
- 228-783-6
- EC Name:
- Trisodium 8-hydroxypyrene-1,3,6-trisulphonate
- Cas Number:
- 6358-69-6
- Molecular formula:
- C16H10O10S3.3Na
- IUPAC Name:
- trisodium 8-hydroxypyrene-1,3,6-trisulphonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material: D & C Green no. 8
- Molecular formula: C16H10O10S3.3Na
- Molecular weight: 524.389 g/mol
- Physical state: Solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hacking & Churchill, Ltd., UK)
- Age at study initiation: no data available
- Weight at study initiation: no data available
- Housing:The animals were conventionally kept in single cages
- Diet (e.g. ad libitum): appropriate diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: no data available
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- About 100 mg of the finely powdered test specimen and 100 microliters of a 30% or 3% strength aqueous solution of the test chemical
- Duration of treatment / exposure:
- single exposure
- Observation period (in vivo):
- The findings were obtained 1, 24, HS and 72 hours after administration and at the end of the follow-up period of 7 days
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: no
SCORING SYSTEM: The condition of cornea, iris and conjunctivae according to DRAIZE was assessed. The condition of cornea, iris and conjunctivae according to DRAIZE was assessed (see rating table). All other findings not covered by the DRAIZE scale were also recorded. For evaluation, the DRAIZE grades were used at approximately 24, 48, and 72 hours after application.
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein : no data available
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Following application of the neat test material, all animals showed slight conjunctival redness which in five of 6 animals was completely reversible within 72 hours, and in one animal within 7 days.
In two animals, very slight tear flow occurred after application which also was completely reversible within 48 hours.
Following application of a 30% aqueous solution of the test material, all animals showed slight conjunctival redness (max. score 1) one hour after application which was completely reversible within 24 hours.
Following application of a 3% aqueous solution, three animals showed slight conjunctival redness (max. score 1) at 24 hours after application which was completely reversible within 48 hours.
Any other information on results incl. tables
Table #: Irritant/corrosive response data for neat substance for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
1/1/2/1/1/1 |
0/2/1/0/1/0 |
24 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
1/2/1/1/0/2 |
0/0/0/0/0/0 |
48 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
1/1/1/1/0/1 |
0/0/0/0/0/0 |
72 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/1/0/0/0/0 |
0/0/0/0/0/0 |
7 d |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
Average 24h, 48h, 72h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0.6/1.3/0.6/0.6/0.0/1.0 |
0/0/0/0/0/0 |
Area effected |
0/0/0/0/0/0 |
|
|
|
Reversibility*) |
|
|
c. |
c. |
Average time (unit) for reversion |
|
|
7 d |
24 h |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Judgment is based on mean scores for each animal following grading at 24, 48 and 72 hours after application of the test material, in consideration of reversibility.
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- The eye potential of the test chemical was evaluated in rabbits. Following application of the neat test material, all animals showed slight conjunctival redness which in five of 6 animals was completely reversible within 72 hours, and in one animal within 7 days. In two animals, very slight tear flow occurred after application which also was completely reversible within 48 hours.
Following application of a 30% aqueous solution of the test material, all animals showed slight conjunctival redness (max. score 1) one hour after application which was completely reversible within 24 hours. Following application of a 3% aqueous solution, three animals showed slight conjunctival redness (max. score 1) at 24 hours after application which was completely reversible within 48 hours. Since the observed effects were reversible by 7 days, the test chemical can be considered to be not irritating to rabbit eyes. - Executive summary:
The eye potential of the test chemical was evaluated in rabbits.
6 albino rabbits were used for the study. The animals were conventionally kept in single cages and were given an appropriate diet and tap water ad libitum.
For each of the 6 rabbits, about 100 mg of the finely powdered test specimen and 100 microliters of a 30% or 3% strength aqueous test chemical solution were applied to the conjunctival sac of one eye. Only animals with intact eyes were used.The untreated eye served as control. The findings were obtained 1, 24, 48 and 72 hours after administration and at the end of the follow-up period of 7 days. The condition of cornea, iris and conjunctivae according to DRAIZE was assessed.
Following application of the neat test material, all animals showed slight conjunctival redness which in five of 6 animals was completely reversible within 72 hours, and in one animal within 7 days. In two animals, very slight tear flow occurred after application which also was completely reversible within 48 hours.
Following application of a 30% aqueous solution of the test material, all animals showed slight conjunctival redness (max. score 1) one hour after application which was completely reversible within 24 hours. Following application of a 3% aqueous solution, three animals showed slight conjunctival redness (max. score 1) at 24 hours after application which was completely reversible within 48 hours. Since the observed effects were reversible by 7 days, the test chemical can be considered to be not irritating to rabbit eyes.
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