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EC number: 228-327-6 | CAS number: 6227-20-9
- 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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 January 2017 (histopathology 5 June 2017 to 16 June 2017)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Principles of method if other than guideline:
- High opacity scores were obtained in the test and the corneas were stained dark purple by the substance, and thus, the opacity scores may have been due to the staining. Therefore conform the guidance additional histopathology was performed
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Trisodium 3-[[4-[[6-(anilino)-1-hydroxy-3-sulphonato-2-naphthyl]azo]-5-methoxy-o-tolyl]azo]naphthalene-1,5-disulphonate
- EC Number:
- 228-327-6
- EC Name:
- Trisodium 3-[[4-[[6-(anilino)-1-hydroxy-3-sulphonato-2-naphthyl]azo]-5-methoxy-o-tolyl]azo]naphthalene-1,5-disulphonate
- Cas Number:
- 6227-20-9
- Molecular formula:
- C34H27N5O11S3.3Na
- IUPAC Name:
- trisodium 3-[[4-[[6-(anilino)-1-hydroxy-3-sulphonato-2-naphthyl]azo]-5-methoxy-o-tolyl]azo]naphthalene-1,5-disulphonate
- Test material form:
- solid: flakes
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: local abattoir
- Number of animals: not indicated
- Storage, temperature and transport conditions of ocular tissue: placed in Hanks’ Balanced Salt Solution (HBSS) supplemented with antibiotics (penicillin at 100 IU/mL and streptomycin at 100 µg/mL), transported over ice packs on the same day of slaughter. The corneas were prepared immediately on arrival.
- Time interval prior to initiating testing: not indicated
- indication of any existing defects or lesions in ocular tissue samples: checked and only undamaged tissue used
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- TEST MATERIAL: 20% w/v solution in sodium chloride 0.9% w/v.
- Duration of treatment / exposure:
- 240 minutes at 32 ± 1 ºC
- Duration of post- treatment incubation (in vitro):
- post treatment opacity measurement immediately
permeality measurement after exposure to fluorescein for 90 min at 32 ± 1 ºC - Details on study design:
- QUALITY CHECK OF THE ISOLATED CORNEAS:based on visual examination and pre-treatment opacity check
NUMBER OF REPLICATES: 2/treatment
TREATMENT METHOD:closed chamber
REMOVAL OF TEST SUBSTANCE: 3 rinses with EMEM containing phenol red
MEASURED ENDPOINTS: Corneal opacity and Corneal permeability
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA:
IVIS Classification
≤ 3 No category. Not requiring classification to UN GHS or EU CLP
> 3; ≤55 No prediction of eye irritation can be made
> 55 Category 1. UN GHS or EU CLP Causes serious eye damage
Histologically process and microscopically evaluation of the isolated bovine eye corneas was performed after in vitro testing.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Value:
- 138.4
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Remarks:
- It can not be excluded that staining of the cornea could have influenced the opacity readings
- Irritation parameter:
- histopathological observations
- Value:
- >= 1 - <= 2
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- not determinable
- Remarks:
- indication of irritation is not sufficient to allow the conclusion severely damaging to the eyes
- Other effects / acceptance of results:
- The positive control was slightly out of range. This was evaluated and considered not to have affected the study validity.
The purple staining of cornea by the test substance may have influenced the opacity reading. This was checked by histologically processing and microscopically evaluation of the isolated bovine eye corneas after in vitro testing (see below)
The histopathology findings were only low grade and restricted to the upper layers of the epithelium, so were not typical of the histopathological findings that would be expected following exposure of the cornea to substances having the potential to cause serious eye damage associated with dense corneal opacity (i.e. not consistent with the corneal effects commonly induced by Category 1 substances). So, it is very likely that the high scores for opacity in the BCOP test were due primarily to staining of the cornea by the test item.
Any other information on results incl. tables
|
Opacity |
Permeability |
|
||
Cornea |
Post-Treatment- Pre-Treatment |
Corrected Value
|
OD
|
Corrected Value
|
In Vitro Irritancy Score
|
Negative control |
0 |
|
0.029 |
|
|
|
1 |
|
0.022 |
|
|
|
1 |
|
0.054 |
|
|
Mean |
0.7* |
|
0.035 |
|
1.2 |
Positive Control |
83 |
82.3 |
1.239 |
1.204 |
|
|
84 |
83.3 |
1.609 |
1.574 |
|
|
82 |
81.3 |
1.482 |
1.447 |
|
Mean |
|
82.3 |
|
1.408 |
103.5 |
Test Item |
182 |
181.3 |
0.230 |
0.195 |
|
|
135 |
134.3 |
0.043 |
0.008 |
|
|
94 |
93.3 |
0.243 |
0.208 |
|
Mean |
|
136.3 |
|
0.137 |
138.4 |
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Based on the results of the test the substance is considered not severely damaging to the eyes
- Executive summary:
In a BCOP assay bovine corneas were exposed to the substance and assessed for opacity and permeability. Opacity was strongly increased, while permeability was slightly increased compared to the negative controls. The calculation of the In Vitro Irritancy Score showed that the substance is severely damaging to the eyes. As it could not be excluded that staining of the cornea could have influenced the opacity readings, semi-quantitative histopathological evaluation of the corneas from eyes exposed to the substance was performed. This investigation gave scores below the threshold for classification of this material as Eye Category 1. Therefore the conclusion of the study is that the substance is not considered severely damaging to the eyes.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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