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Reaction mass of 3-[(4-amino-6-bromo-5,8-dihydro-1-hydroxy-8-imino-5-oxo-2-naphtyl)amino]-N,N,N-trimethylanilinium chloride and 3-[(8-amino-dibromo-5-hydroxy-4-imino-1-oxo-1,4-dihydronaphthalenyl)amino]-N,N,N-trimethylbenzenaminium chloride and 3-[(bromo-1,4-dihydroxy-8-imino-5-oxo-5,8-dihydronaphthalenyl)amino]-N,N,N-trimethylbenzenaminium chloride
EC number: 916-466-1 | CAS number: -
- 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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction mass of 3-[(4-amino-6-bromo-5,8-dihydro-1-hydroxy-8-imino-5-oxo-2-naphtyl)amino]-N,N,N-trimethylanilinium chloride and 3-[(8-amino-dibromo-5-hydroxy-4-imino-1-oxo-1,4-dihydronaphthalenyl)amino]-N,N,N-trimethylbenzenaminium chloride and 3-[(bromo-1,4-dihydroxy-8-imino-5-oxo-5,8-dihydronaphthalenyl)amino]-N,N,N-trimethylbenzenaminium chloride
- EC Number:
- 916-466-1
- IUPAC Name:
- Reaction mass of 3-[(4-amino-6-bromo-5,8-dihydro-1-hydroxy-8-imino-5-oxo-2-naphtyl)amino]-N,N,N-trimethylanilinium chloride and 3-[(8-amino-dibromo-5-hydroxy-4-imino-1-oxo-1,4-dihydronaphthalenyl)amino]-N,N,N-trimethylbenzenaminium chloride and 3-[(bromo-1,4-dihydroxy-8-imino-5-oxo-5,8-dihydronaphthalenyl)amino]-N,N,N-trimethylbenzenaminium chloride
- Test material form:
- solid: particulate/powder
- Details on test material:
- Identification : Basic Blue 99
Batch number : RS27988101
3-[(Bromo-8-amino-5-hydroxy-4-imino-1-oxo-1,4-dihydronaphthalenyl)amino]-N,N,N-trimethylbenzeneaminium cation (main) : 50.2a/a%
3-[(Dibromo-8-amino-5-hydroxy-4-imino-1-oxo-1,4-dihydronaphthalenyl)amino]-N,N,N-trimethylbenzeneaminium cation (E) : 14.6a/a% 3-[(Bromo-8-amino-5-hydroxy-1,4-dioxo-1,4-dihydronaphthalenyl)amino]-N,N,N-trimethylbenzeneaminium cation (F) : 16.9a/a%
3-[(Bromo-5,8-dihydroxy-1,4-dioxo-1,4-dihydronaphthalenyl)amino]-N,N,N-trimethylbenzeneaminium cation (J) : 4.8a/a% 3-[(8-Amino-5-hydroxy-4-imino-1-oxo-1,4-dihydronaphthalenyl)amino]-N,N,N-trimethylbenzeneaminium cation (A) : 1.0a/a% 3-[(Sulpho-8-amino-5-hydroxy-1,4-dioxo-1,4-dihydronaphthalenyl)amino]-N,N,N-trimethylbenzeneaminium cation (B) : 2.0a/a%
3-[(Dibromo-8-amino-5-hydroxy-1,4-dioxo-1,4-dihydronaphthalenyl)amino]-N,N,N-trimethylbenzeneaminium cation (G): 2.8a/a%
3-[(Sulpho-8-amino-5-hydroxy-4-imino-1-oxo-1,4-dihydronaphthalenyl)amino]-N,N,N-trimethylbenzeneaminium cation (O) :<0.3a/a%
3-[(Bromo-sulpho-8-amino-5-hydroxy-1,4-dioxo-1,4-dihydronaphthalenyl)amino]-N,N,N-trimethylbenzeneaminium cation (N) : 2.1a/a%
Tribromo-8-amino-5-hydroxy-1,4-naphthoquinone (L) : 1.3a/a%
Chloride ion : 14.5%
Sulphate ion : 0.1%
Acetate ion : 0.2%
Zinc ion : 5.5%
Water : 4.1%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1g
- Duration of treatment / exposure:
- It was suspected that the test item might produce irritancy. Therefore, a single animal (one female) was treated first. As severe irritant effects were observed after the 1 and 24 hour examinations up to 72 hours after treatment, the study was closed without treating the remaining two animals. The animal was treated by instillation of 0.1g of the test substance in the conjunctival sac of the left eye after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test item. The right eye remained untreated and served as the reference control. Twenty four hours after treatment, the treated and untreated eyes were rinsed with lukewarm tap water.
- Observation period (in vivo):
- Approximately 1, 24, 48 and 72 hours after instillation of the test substance.
- Number of animals or in vitro replicates:
- One
- Details on study design:
- The ocular reaction was assessed according to the numerical scoring system listed in EEC Commission Directive 92/69/EEC, July 31, 1992 at approximately 1, 24, 48 and 72 hours after instillation.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Remarks on result:
- other: Not assessable due to staining produced by the test item
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24 hours
- Remarks on result:
- other: Not assessable due to staining produced by the test item
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 48 hours
- Score:
- 3
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 72 hours
- Score:
- 3
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: mean value after 24, 48 and 72 hours
- Score:
- 3
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Remarks on result:
- other: Not assessable due to staining produced by the test item
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24 hours
- Remarks on result:
- other: Not assessable due to staining produced by the test item
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 48 hours
- Score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 72 hours
- Score:
- 2
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: mean value after 24, 48 and 72 hours
- Score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Remarks on result:
- other: Not assessable due to staining produced by the test item
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Time point:
- other: 24 hours
- Remarks on result:
- other: Not assessable due to staining produced by the test item
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Time point:
- other: 48 hours
- Remarks on result:
- other: Not assessable due to staining produced by the test item
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Time point:
- other: 72 hours
- Remarks on result:
- other: Not assessable due to staining produced by the test item
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Time point:
- other: mean value after 24, 48 and 72 hours
- Remarks on result:
- other: Not assessable due to staining produced by the test item
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24 hours
- Score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 48 hours
- Score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 72 hours
- Score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: mean value after 24, 48 and 72 hours
- Score:
- 3.67
Applicant's summary and conclusion
- Interpretation of results:
- other: Eye Damage 1 (H318 : Causes serious eye damage)
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Based upon the referred classification criteria (Commission Directive 2001/59/EC), the test item is considered to be classified as R41 - risk of serious damage to eyes. The test item is classified as Eye Damage 1 - causes serious eye damage under EU Regulation 1272/2008.
- Executive summary:
The primary eye irritation potential of Basic Blue 99 was investigated according to OECD guideline 405. The test item was applied by instillation of 0.1g into the left eye of a young adult New Zealand White rabbit. Twenty four hours after treatment, the treated and untreated eye were rinsed with lukewarm tap water. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test item instillation. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for the animal for corneal opacity, iris, redness and chemosis of the conjunctivae in so far as numerical scores were assessable. The individual mean score for corneal opacity was 3.0 and for the iris the maximum score of 2.0. The reddening of the conjunctivae was not assessable throughout the observation period and the individual mean score for chemosis was 3.7. The instillation of Basic Blue 99 into the eye of one animal resulted in severe and early onset ocular changes, discharge and chemosis. The assessment of the redness of the conjunctivae and sclera was not possible throughout the observation period due to staining produced by the test item. The assessment of the cornea and iris was also not possible 1 and 24 hours after treatment due to staining produced by the test item. Marked opacity, affecting the whole area, was noted in the eye at the 48 and 72 hour reading as well as an absent light reflex. Marked black to blue staining of the treated eye by the test item was evident from the 1 hour reading up to 72 hours after treatment. No clinical signs were observed. It was agreed to close the study with one treated animal after the 72 hour reading. Based upon the referred classification criteria (Commission Directive 2001/59/EC), the test item is considered to be classified as R41 - risk of serious damage to eyes. The test item is classified as Eye Damage 1 - causes serious eye damage under EU Regulation 1272/2008.
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