Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 601-472-6 | CAS number: 117314-20-2
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28.10.2014 - 30.10. 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study was performed by following the recommended method (OECD Guideline for the Testing of Chemicals No. 431 “In Vitro Skin Corrosion: Human Skin Model Test”) and GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- Adopted 13.4.2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GLP certificate is as an appendix to the study report.
Test material
- Reference substance name:
- nonatitanium(4+) tetrasodium hydrate icosaoxidandiide
- EC Number:
- 601-472-6
- Cas Number:
- 117314-20-2
- Molecular formula:
- Sodium form: Na4Ti9O20 × n H2O Sodium/hydrogen form: 50 % Na4Ti9O20 × n H2O, 50 % Na2H2Ti9O20 × n H2O
- IUPAC Name:
- nonatitanium(4+) tetrasodium hydrate icosaoxidandiide
- Test material form:
- solid: particulate/powder
- Remarks:
- powder
- Details on test material:
- - Substance type: commercial product (pure active substance)
- Physical state: Solid powder
- Storage condition of test material: Ambient temperature, humidity and pressure. Stored in sealed containers in darkness.
- Stability under test conditions: Stable
- Purity: ca 100 %
- Particle size distribution: 2.92% <100μm
- Crystal structure: TiO6-octaedra
- Density: 2.83 x 10^3 kg/m3
- pH value: the pH value of the substance in an aqueous solution is appr. 11
Constituent 1
- Specific details on test material used for the study:
- The substance is alkaline, and when in water the pH is about 11.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: The target cells are epithelial, derived from human skin, and formed into a stratified, cornified epithelium.
- Justification for test system used:
- The test model incorporates several features, which make it advantageous in the study of potential dermal corrosivity potential. The target cells are epithelial, derived from human skin, and formed into a stratified, cornified epithelium. Test items are applied to the culture surface, at air interface, so that undiluted and/or end use dilutions can be tested directly. Cytotoxicity is determined by the reduction of MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to formazan by viable cells in the test item treated tissues relative to the corresponding negative control. The results are used to make a prediction of corrosivity potential of the test item.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 Celsius degrees
- Temperature of post-treatment incubation (if applicable): After rinsing of the test item, the test plates were incubated (37 C, 5% CO2) for 3 hours with MTT. For MTT extraction, 2 mL of Isopropanol was used to completely immerse each insert. The plates were placed into a refrigerator overnight, to allow extraction to proceed.
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: Rinsing was achieved by filling and emptying each tissue under a constant soft stream of DPBS to gently remove any residual test
item. Excess DPBS was removed by blotting the bottom of the tissue insert with tissue paper. Each tissue was placed into the prepared holding plate until all tissues were rinsed.
- Observable damage in the tissue due to washing: no
DYE BINDING METHOD
- Dye used in the dye-binding assay: MTT
- Spectrophotometer: Absorbency of each sample well was measured using the Anthos 2001 microplate reader
- Wavelength: 562nm (OD562)
DECISION CRITERIA
- The corrosivity potential of the test item was predicted from the relative mean tissue viabilities obtained after the 3 and 60-Minute exposure periods, compared to the mean of the negative control tissues (n=2) treated with sterile distilled water. Classification of corrosivity potential was based on relative viabilities for each exposure time
according to the following prediction model:
Mean tissue viability (% negative control) Prediction: Corrosive/Non-Corrosive
3 minute exposure : <50 Corrosive
3 minute exposure : >50
60 minute exposure : <15 Corrosive
3 minute exposure : >50
60 minute exposure : >15 Non-corrosive - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 mg of test item
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL of sterile distilled water
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL of Potassium Hydroxide
- Concentration (if solution): 8.0 N - Duration of treatment / exposure:
- 3-Minute exposure period
60-Minute exposure period - Duration of post-treatment incubation (if applicable):
- After rinsing of the test item, the test plates were incubated (37 C, 5% CO2) for 3 hours with MTT. For MTT extraction, 2 mL of Isopropanol was used to completely immerse each insert. The plates were placed into a refrigerator overnight, to allow extraction to proceed.
- Number of replicates:
- 2x 3-Minute exposure
2x 60-Minute exposure
Test animals
- Species:
- human
- Details on test animals or test system and environmental conditions:
- TEST TISSUE:
Tissue: EPIDERM™ Reconstructed Human Epidermis Model Kit
Supplier: MatTek Corporation, Ashland, MA, USA
Date received: 28 October 2014
EpiDermTM Tissues (0.5cm2) lot number : 19690, Kit D
Assay Medium lot number : 102314TMD
Upon receipt of the EpidermTM tissues, the sealed 24-well plate was placed into a refrigerator overnight.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: Not applicable. Skin tissue.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 mg of test item
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL of sterile distilled water
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL of Potassium Hydroxide
- Concentration (if solution): 8.0 N - Duration of treatment / exposure:
- Two exposure periods:
- 3 minutes
- 60 minutes - Observation period:
- Three hours incubation with MTT (37 C, 5% CO2), after rinsing the tissues from the test material with the help of Dulbecco’s phosphate buffered saline (DPBS). For MTT extraction, 2 mL of Isopropanol was used to completely immerse each insert. The plates were placed into a refrigerator overnight, to allow extraction to proceed.
- Number of animals:
- Two tissue samples per exposure period.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Rinsing was achieved by filling and emptying each tissue under a constant soft stream of DPBS to gently remove any residual test item. Excess DPBS was removed by blotting the bottom of the tissue insert with tissue paper.
- Time after start of exposure: Three minutes or 60 minutes.
SCORING SYSTEM:
Quantitative MTT Assessment (percentage tissue viability)
The corrosivity potential of the test item was predicted from the relative mean tissue viabilities obtained after the 3 and 60-Minute exposure periods, compared to the mean of the negative control tissues (n=2) treated with sterile distilled water.
The relative mean viabilities were calculated in the following way:
Relative mean viability (%) = (mean OD562 of test item / mean OD562 of negative control) x 100
Classification of corrosivity potential was based on relative viabilities for each exposure time
according to the following prediction model:
Mean tissue viability (% negative control) Prediction (Corrosive/Non-Corrosive)
- 3 minute exposure : <50 Corrosive
-3 minute exposure : >50 and 60 minute exposure : <15 Corrosive
- 3 minute exposure : >50 and 60 minute exposure : >15 Non-corrosive
Quality Criteria
The results of the assay are considered acceptable if the following assay acceptance criteria are achieved:
Negative Control:
The assay establishes the acceptance criterion for an acceptable test if the mean optical density for the negative control treated tissues is 0.8 or higher.
Positive Control:
The assay establishes the acceptance criterion for an acceptable test if the relative mean tissue viability for the positive control treated tissues was ≤ 30% relative to the negative control treated tissues following the 3-Minute exposure period.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3-Minute exposure
- Value:
- 94.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60-Minute exposure
- Value:
- 99.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Direct-MTT reduction: The MTT solution containing the test item did not turn blue. This was taken to indicate the test item did not reduce MTT.
- Colour interference: No. In this case, the true metabolic MTT reduction and the false direct MTT reduction can be differentiated and quantified.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes. The mean OD562 for the negative control treated tissues was 1.826 for the 3-Minute exposure period and 2.243 for the 60-Minute exposure period. The negative control acceptance criteria were therefore satisfied.
- Acceptance criteria met for positive control: Yes. The relative mean tissue viability for the positive control treated tissues was 8.5 % relative to the negative control treated tissues following the 3-Minute exposure period. The positive control acceptance criterion was therefore satisfied.
Any other information on results incl. tables
Table 1. Mean OD562 Values and Viabilities for the Negative Control Item, Positive Control Item and Test Item
Item | Exposure Time | Mean OD562** | % Viability |
Negative Control | 3 minute | 1.826 | 100* |
60 minute | 2.243 | 100* | |
Positive Control | 3 minute | 0.156 | 8.5 |
60 minute | 0.088 | 3.9 | |
Test Item | 3 minute | 1.732 | 94.9 |
60 minute | 2.235 | 99.6 |
* = The mean viability of the negative control tissues is set at 100%
** = Mean of EpiDerm tissues tested in duplicate
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- According to GHS, the substance is not classified as corrosive to the skin.
- Conclusions:
- The test item was considered to be non-corrosive to the skin. Therefore, it is not classified as corrosive to skin.
- Executive summary:
Introduction
The purpose of this test is to evaluate the corrosivity potential of the test item using the EPIDERM™ Human Skin Model after treatment periods of 3 and 60 minutes.
Corrosion is directly related to cytotoxicity in the EpiDerm tissue. Cytotoxicity is determined by the reduction of MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to formazan by viable cells in the test item treated tissues relative to the corresponding negative control. The results are used to make a prediction of the corrosivity potential of the test item.
Methods
Duplicate tissues were treated with the test item for exposure periods of 3 and 60 minutes. At the end of the exposure period the test item was rinsed from each tissue before each tissue was taken for MTT-loading. After MTT loading each tissue was placed in 2 mL Isopropanol for MTT extraction.
At the end of the formazan extraction period each well was mixed thoroughly and triplicate 200 L samples were transferred to the appropriate wells of a pre-labeled 96-well plate. The optical density (OD) was measured at 562 nm (OD562).
Data are presented in the form of percentage viability (MTT reduction in the test item treated tissues relative to negative control tissues).
Results
The relative mean viabilities of the test item treated tissues were: 60 minutes exposure : 99.6 % 3 minutes exposure : 94.9% Quality criteria: The quality criteria required for acceptance of results in the test were satisfied.
Conclusion
The test item was considered to be non-corrosive to the skin.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)