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EC number: 474-080-4 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23.8.-28.8.2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- Adopted: June 18th, 2019
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 474-080-4
- EC Name:
- -
- Cas Number:
- 76801-93-9
- Molecular formula:
- C14H18I3N3O6
- IUPAC Name:
- 5-amino-N1,N3-bis(2,3-dihydroxypropyl)-2,4,6-triiodobenzene-1,3-dicarboxamide
- Reference substance name:
- Unknown impurities
- Molecular formula:
- Not available
- IUPAC Name:
- Unknown impurities
- Test material form:
- solid
Constituent 1
impurity 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 00104016
- Expiration date of the lot/batch: 12/2020
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Store in cool place. Keep container tightly closed in a dry and well-ventilated place.
- Stability under test conditions: Stable
In vitro test system
- Test system:
- human skin model
- Remarks:
- a reconstructed human epidermal model EpiDerm™ (EPI-200, MatTek)
- Source species:
- human
- Cell type:
- other: normal human-derived epidermal keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: The reconstructed human epidermal model EpiDerm™ (EPI-200, MatTek, Bratislava, SK)
- Tissue batch number(s): Lot No. 30820, kit A
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37±1°C
- Temperature of post-treatment incubation (if applicable): 37±1°C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Tissues were thoroughly rinsed and blotted to remove the test item/control
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: Tissues were transferred to 24-well plates containing MTT medium (1 mg·mL-1)
- Incubation time: 3 hr
- Spectrophotometer: Libra S22. Isopropyl alcohol serves as a blank.
- Wavelength: 570±30 nm
NUMBER OF REPLICATE TISSUES: 3
EXPERIMENTAL PROCEDURES
1. Complementary experimets - Direct MTT reduction (test item did not reduce MTT directly) and colour interference (colour of test item did not interfere with the endpoint)
2. MTT Test
3. OD50 measuring
DECISION CRITERIA
According to the OECD TG 431 as well as to the EU Method B.40, the test substance is considered to be corrosive to skin:
i) if the viability after 3 minutes exposure is less than 50 %, or
ii) if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15 %.
The test substance is considered to be non-corrosive to skin:
i) if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is greater than or equal to 15 % - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Test item: 25 mg, no vehicle
NC: water for injection (50 μL)
PC: 8N KOH (50 μL) - Duration of treatment / exposure:
- 3 and 60 minutes
- Duration of post-treatment incubation (if applicable):
- 3 h
- Number of replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- after 3 min treatment
- Value:
- 99
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- after 60 min treatment
- Value:
- 101.7
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS: All assay acceptance criteria have been met.
Negative control: The assay meets the acceptance criterion - OD570 of the NC tissues was 1.741(3 min) and 1.716 (60 min) which is ≥ 0.8 and ≤ 2.8.
Positive control: Viability of tissues treated with 8N KOH after 60 minutes treatment was 5.5% which is <15%.
Any other information on results incl. tables
MTT test results
time |
treatment |
OD570 |
mean |
SD |
CV |
% NC |
|||
tissues |
|||||||||
1 |
2 |
3 |
|||||||
3min |
NC |
water |
1.729 |
1.751 |
1.742 |
1.741 |
0.009 |
0.005 |
|
C1 |
227/19 |
1.752 |
1.646 |
1.771 |
1.723 |
0.055 |
0.032 |
99.0 |
|
PC |
8N KOH |
0.172 |
0.118 |
0.120 |
0.137 |
0.025 |
0.183 |
7.9 |
|
60 min. |
NC |
water |
1.765 |
1.643 |
1.740 |
1.716 |
0.053 |
0.031 |
|
C1 |
227/19 |
1.890 |
1.764 |
1.579 |
1.744 |
0.128 |
0.073 |
101.7 |
|
PC |
8N KOH |
0.096 |
0.082 |
0.106 |
0.095 |
0.010 |
0.104 |
5.5 |
NC negative control
PC positive control
C2 test item
mean arithmetic mean
% NC viability of single tissues compared with negative control
SD standard deviation
CV coefficient of variance
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the above-described experimental design, the test item ATIBA-A was non-corrosive in In vitro Skin Corrosion Test on EpiDermTM tissues.
- Executive summary:
The test item ATIBA-A was assayed for in vitro skin corrosion in the human epidermal model EpiDermTM. The test was performed according to OECD Test Guideline 431, In Vitro Skin Corrosion: Human Skin Model Test, Adopted: June 18th, 2019.
A test for assessing the interference of colour excluded the influence of colour on the endpoint.
A test for direct reduction demonstrated that the test item did not reduce MTT directly. Thus, no steps for correction of results were performed.
In the skin corrosion test, the test item (25 mg) was placed atop previously moistened tissue. The length of exposure was 3 and 60 minutes. Nine tissues were used for each timepoint: three per test item (C1), three for positive control (PC) and three for negative control (NC).
After rinsing, the tissues were incubated with MTT for three hours and then extracted with isopropyl alcohol overnight at room temperature with shaking. The OD570 of the isopropyl alcohol extracts was were measured on a spectrophotometer. Relative cell viability was calculated for each tissue as % of the mean viability of the negative control tissues.
All the assay acceptance criteria were met.
Under the above-described experimental design, the average viability of tissues treated with the test item ATIBA-A was 99.0 % of the negative control average value after 3 minutes treatment and 101.7 % after 60 minutes of treatment.
The test item is considered to be non-corrosive to skin:
i) if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is greater than or equal to 15 %.
In the experiment arrangement described above, the test item ATIBA-A was non-corrosive in the EpiDermTM model.
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