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EC number: 224-618-7 | CAS number: 4430-18-6
- 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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 22 April 2014 to 18 September 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- 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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Sodium 4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]toluene-3-sulphonate
- EC Number:
- 224-618-7
- EC Name:
- Sodium 4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]toluene-3-sulphonate
- Cas Number:
- 4430-18-6
- Molecular formula:
- C21H15NO6S.Na
- IUPAC Name:
- sodium 2-[(4-hydroxy-9,10-dioxo-9,10-dihydroanthracen-1-yl)amino]-5-methylbenzenesulfonate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: supplied by Vivimed, lot no. 20140101
- Expiration date of the lot/batch: January 2016
- Purity test date: 16th January 2016
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:room temperature in the dark
- Stability under test conditions: stable within two hours
- Solubility and stability of the test substance in the solvent/vehicle: stable within two hours
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
the test item was prepared as a 20% w/v solution in 0.9% w/v sodium chloride solution.
The test item was formulated within two hours of being applied to the test system. It is assumed that the formulation was stable for this duration.
No analysis was conducted to determine the homogeneity, concentration or stability of the test item formulation. This is an exception with regard to GLP and has been reflected in the GLP compliance statement.
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Remarks:
- adult cattle
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: local abattoir
- Age at study initiation: typically 12 to 60 months old
- Weight at study initiation: not applicable
- Housing: not applicable
- Diet (e.g. ad libitum): not applicable
- Water (e.g. ad libitum): not applicable
- Acclimation period: not applicable
Test system
- Vehicle:
- other: 0.9% sodium chloride solution
- Controls:
- yes
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.75 mL
- Concentration (if solution): 20%
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.75 mL of test item in 0.9% w/v sodium chloride applied
- Concentration (if solution): 0.9%w/v sodium chloride
- Lot/batch no. (if required): 300999 104
- Purity: 0.9% - Duration of treatment / exposure:
- 240 minutes
- Duration of post- treatment incubation (in vitro):
- 90 minutes
- Number of animals or in vitro replicates:
- triplicate
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
The eyes were excised by an abattoir employee after slaughter, and were placed in Hanks’ Balanced Salt Solution (HBSS) supplemented with antibiotics (penicillin at 100 IU/mL and streptomycin at 100 μg/mL). They were transported to the test facility over ice packs on the same day of slaughter. The corneas were prepared immediately on arrival.
All eyes were macroscopically examined before and after dissection. Only corneas free of damage were used.
The cornea from each selected eye was removed leaving a 2 to 3 mm rim of sclera to facilitate handling. The iris and lens were peeled away from the cornea. The isolated corneas were immersed (epithelial side uppermost) in a dish containing HBSS until they were mounted in Bovine Corneal Opacity and Permeability (BCOP) holders
QUALITY CHECK OF THE ISOLATED CORNEAS
The medium from both chambers of each holder was replaced with fresh complete MEM.
A pre-treatment opacity reading was taken for each cornea using a calibrated opacitometer. The average opacity for all corneas was calculated. Three corneas with opacity values close to the median value of all corneas were allocated to the negative control.
NUMBER OF REPLICATES
Three corneas were also allocated to the test item and three corneas to the positive control item
NEGATIVE CONTROL USED
SOLVENT CONTROL USED (if applicable)
0.9% w/v Sodium chloride solution
POSITIVE CONTROL USED
20% w/v Imidazole solution in 0.9%w/v sodium chloride solution
APPLICATION DOSE AND EXPOSURE TIME
0.75 mL of the test item preparation or control items were applied to the appropriate corneas for 240 minutes exposure time
TREATMENT METHOD: closed chamber
POST-INCUBATION PERIOD: No
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: three times
- POST-EXPOSURE INCUBATION: No
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: The change in opacity for each cornea (including the negative control) was calculated by subtracting the initial opacity reading from the final opacity reading. These values were then corrected by subtracting the average change in opacity observed for the negative control corneas. The mean opacity value of each treatment group was then calculated by averaging the corrected opacity values of each cornea for that treatment group.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microtiter plate reader](OD490)
- Others (e.g, pertinent visual observations, histopathology): Histopathology
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA:
The test item is classified according to the prediction model below:
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.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Main Test : Negative Control
- Value:
- 2.9
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Main Test : Positive Control
- Value:
- 75
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Main test : Test item
- Value:
- 68.1
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: No but histopathology showed necrosis.
DEMONSTRATION OF TECHNICAL PROFICIENCY: Imidazole sued as positive control and induce good positive response to the test system.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Range of historical values if different from the ones specified in the test guideline: Not specified
The In Vitro irritancy score for the test item, 68.1, suggested that classification as serious eye damage was appropriate. However the intensely colored Test Item had interfered with the study parameter of opacity and therefore histopathology was conducted as a confirmatory parameter. The results of histopathology identified necrosis to all cell layers of the cornea indicating that the In Vitro irritancy score, although artificially increased by the staining of the cornea, did not produce an over prediction of ocular irritancy potential.
Any other information on results incl. tables
Table1 Individual and Mean Corneal Opacity and PermeabilityMeasurements
Treatment |
Cornea Number |
Opacity |
Permeability (OD) |
In VitroIrritancy Score |
||||
Pre-Treatment |
Post-Treatment |
Post-Treatment Pre-Treatment |
Corrected Value |
|
Corrected Value |
|||
Negative
Control |
10 |
2 |
5 |
3 |
|
0.046 |
|
|
11 |
2 |
3 |
1 |
|
0.071 |
|
|
|
12 |
2 |
4 |
2 |
|
0.058 |
|
|
|
|
|
|
2.0* |
|
0.058 |
|
2.9 |
|
Positive
Control |
1 |
3 |
51 |
48 |
46.0 |
1.558 |
1.500 |
|
2 |
1 |
60 |
59 |
57.0 |
1.224 |
1.166 |
|
|
3 |
3 |
68 |
65 |
63.0 |
1.322 |
1.264 |
|
|
|
|
|
|
55.3 |
|
1.310 |
75.0 |
|
Test Item |
4 |
2 |
31 |
29 |
27.0 |
2.265 |
2.207 |
|
5 |
1 |
50 |
49 |
47.0 |
1.916 |
1.858 |
|
|
6 |
3 |
44 |
41 |
39.0 |
2.086 |
2.028 |
|
|
|
|
|
|
37.7 |
|
2.031 |
68.1 |
OD =Opticaldensity* = Mean of the post-treatment pre-treatmentvalues =MeanValue
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Under the experimental condition of the study, the registered substance Acid Violet 43 induced an in vitro irritancy score of 68.1 and histopathology showed necrosis to all cell layers of the cornea. Hence, the test substance was classified as Category 1 for Eye Irritation, causes serious eye damage according CLP regulation.
- Executive summary:
The purpose of this GLP study was to identify Acid Violet 43 eye effect that can induce serious eye damage using OECD Guideline 439 method for Bovine Corneal Opacity and Permeability Assay (BCOP).
The test item was applied at a concentration of 20% w/v in 0.9% w/v sodium chloride solution for 240 minutes. Negative and positive control items were tested concurrently. The two endpoints, decreased light transmission through the cornea (opacity) and increased passage of sodium fluorescein dye through the cornea (permeability) were combined in an empirically derived formula to generate an In Vitro Irritancy Score (IVIS). Histopathological evaluation of the corneas at the end of the treatment was performed as an additional endpoint.
Histological evaluation revealed that the test item induced much loss of the epithelium and any remaining cells were necrotic. The In Vitro irritancy score for the test item, 68.1.
Under the experimental condition of the study, the registered substance Acid Violet 43 induced an in vitro irritancy score of 68.1 and histopathology showed necrosis to all cell layers of the cornea. Hence, the test substance was classified as Category 1 for Eye Irritation, causes serious eye damage according CLP regulation.
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