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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 4 March 2014 to 10 March 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- yes
- Remarks:
- Results from water killed tissues were not used; these deviation was considered not to affect the integrity of the study
- 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: not specified, test item used pure
- Solubility and stability of the test substance in the solvent/vehicle: not specified, test item used pure
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test item was used as supplied
In vitro test system
- Test system:
- artificial membrane barrier model
- Source species:
- human
- Cell type:
- other: Reconstrcted Human Epidermis EPISKINtm
- Cell source:
- other: Reconstrcted Human Epidermis EPISKINtm
- Source strain:
- not specified
- Justification for test system used:
- Following a full validation study the EpiSkinTM reconstructed human epidermis model showed evidence of being a reliable and relevant stand-alone test for predicting rabbit skin irritation when the endpoint is measured by MTT reduction and for being used as a replacement for the Draize Skin Irritation Test for the purpose of distinguishing between Irritating and Non-Irritating test items.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiSkinTM
- Tissue batch number(s): 14-EKIN-007
- Production date: not specified
- Shipping date: not specified
- Delivery date: 4 March 2014
- Date of initiation of testing: 4 March 2014
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure:37 deg Celsius
- Temperature of post-treatment incubation (if applicable): 37 deg Celsius
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: one washing step after the 15 minutes exposure period with DPBS with Ca++ and Mg++
- Observable damage in the tissue due to washing: Not specified
- Modifications to validated SOP: Not specified
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration:0.3mg/mL
- Incubation time:3 hours at 37 deg Celsius
- Spectrophotometer: Anthos 2001
- Wavelength:562nm
- Filter:no reference filter used
- Filter bandwidth: no filter used
- Linear OD range of spectrophotometer:not specified
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
No historical data provided
NUMBER OF REPLICATE TISSUES: triplicates per conditions
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Water killed tissues used
- Procedure used to prepare the killed tissues (if applicable): Water-killed tissues were prepared by placing untreated EpiSkinTM tissues in a 12 well plate containing 2.0 mL distilled water in each well. The tissues were incubated at 37 deg Celsius 5% CO2 in air for 48±1 hours. At the end of the incubation time the water was discarded. Once killed the tissues were stored in a freezer (-14 to -30 deg Celsius) for up to 6 months. Before used each tissue was thawed by placing in 2.0 mL of maintenance medium due to residual reducing enzymes within the killed tissues.
- N. of replicates : triplicate
- Method of calculation used: Relative mean viability (%) = (mean OD562 of test item / mean OD 562 of negative control ) x100
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 2 sequencies : pre incubation and main test
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be irritant to skin if the viability after 15 minutes exposure and 42 hours post exposure period is less than 50%,
- The test substance is considered to be non-irritant to skin if the viability after 15 minutes exposure and 42 hours post exposure period is greater than
- Justification for the selection of the cut-off point(s) if different than recommended in TG 431 and 439: - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mg (26.3 mg/cm2)
- Concentration (if solution): used pure
VEHICLE
no vehicle, 5µL of distilled water was applied on topically applied to improve the contact between skin and the test item
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 10 µL
- Concentration (if solution): used pure
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 10µL
- Concentration (if solution): 5% (w/v) - Duration of treatment / exposure:
- 15 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- triplicate
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Main Test : Negative Control
- Value:
- 100
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Main Test : Positive control
- Value:
- 7.7
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Main Test : Test Item
- Value:
- 96.1
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: Not specified
- Direct-MTT reduction: No direct reduction
- Colour interference with MTT: No interference
DEMONSTRATION OF TECHNICAL PROFICIENCY: SDS used as positive control
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: Yes
- Acceptance criteria met for variability between replicate measurements:Yes
- Range of historical values if different from the ones specified in the test guideline: Not specified
Any other information on results incl. tables
Table1 :Mean OD562Values and Viabilities for the Negative Control Item, Positive Control Item and Test Item
Item |
OD562 of tissues |
Mean of OD562 |
± SD of OD562 |
Relative individual tissue viability (%) |
Relative mean viability (%) |
± SD of Relative mean viability(%) |
Negative Control |
0.914 |
0.915 |
0.030 |
99.9 |
100* |
3.3 |
0.886 |
96.8 |
|||||
0.945 |
103.3 |
|||||
Positive Control |
0.095 |
0.071 |
0.021 |
10.4 |
7.7 |
2.3 |
0.059 |
6.4 |
|||||
0.046 |
6.4 |
|||||
Test Item |
0.829 |
0.879 |
0.044 |
90.6 |
96.1 |
4.8 |
0.897 |
98.0 |
|||||
0.912 |
99.7 |
*set at 100%
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of the study, the test item Acid Violet 43 did not induce irritation to skin sample EpiSkinTM after 15 minutes exposure period and 42 hours post exposure period (96.1% of viability). Hence, the substance was considered as Not Irritating to skin according CLP regulation.
- Executive summary:
The purpose of this GLP compliant test was to evaluate the skin irritation potential of the test item using the EpiSkinTM reconstructed human epidermis model after a treatment period of 15 minutes followed by a post-exposure incubation period of 42 hours according to the OECD guideline 439 method.
Triplicate tissues were treated with the test item for an exposure period of 15 minutes. Additional non-viable tissues were incorporated into the testing for correction purposes to MTT interferences (Water-killed tissues). At the end of the exposure period each tissue was rinsed before incubating for 42 hours. At the end of the post-exposure incubation period each tissue was taken for MTT-loading. The maintenance medium from beneath each tissue was transferred to pre-labeled micro tubes and stored in a freezer for possible inflammatory mediator determination. After MTT-loading a total biopsy of each epidermis was made and placed into micro tubes containing acidified isopropanol for extraction of formazan crystals out of the MTT-loaded tissues.
The relative mean viability of the test item treated tissues was 96.1% after the 15-Minute exposure period and 42-Hours post-exposure incubation period.
Under the experimental conditions of the study, incubation of the registered substance Acid Violet 43 led to a relative mean viability at 63.3% compared to negative control. Hence, the registered substance was classified as Non-irritant (EU CLP Not classified for Irritation).
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