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Diss Factsheets
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EC number: 952-967-1 | 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:
- 2010-03-29 to 2010-03-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP guideline study reliable without restrictions
- Justification for type of information:
- Disodium titanate substance (EC 234-802-9) has the molecular formula Na2TiO3 and its composition is expressed as (Na2O)x(TiO2), where x is ranging from 0.1 to 6 according to the SIP. This substance, Reaction mass of Disodium Hexatitanate and Sodium Metatitanate, has a value of x = 0.21, calculated from XRF results, has been identified as a mixture of two specific types of disodium titanate and is therefore within the scope of the disodium titanate SIP.
It is assessed therefore that disodium titanate is an acceptable read-across substance for Reaction mass of Disodium Hexatitanate and Sodium Metatitanate
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ICCVAM Minimum Performance Standards: In Vitro Membrane Barrier Test Systems for Skin Corrosion, June 23, 2003
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ICCVAM Recommended Performance Standards for in vitro Test Methods for Skin Corrosion, May 2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2009-03-30
Test material
- Reference substance name:
- Disodium titanate
- EC Number:
- 234-802-9
- EC Name:
- Disodium titanate
- Cas Number:
- 12034-34-3
- Molecular formula:
- Na2TiO3
- IUPAC Name:
- disodium titanate
- Details on test material:
- - Name of test material (as cited in study report): Disodium titanate
- Physical state: light yellow powder
- Storage condition of test material: At room temperature, in tightly closed container
No further information on the test material was stated.
Constituent 1
Test animals
- Details on test animals or test system and environmental conditions:
- Not applicable - Since this is a in vitro study there is no information on test animals.
Test system
- Amount / concentration applied:
- TEST MATERIAL
Qualify Test: approx. 100 mg of the test item were applied into the “Qualify Test Vial”
Categorisation Test: approx. 100 mg of the test item were applied into the “Category A Vial” as well as into the “Category B Vial”
Classification Test: approx. 500 mg of the test item were applied per bio-barrier - Duration of treatment / exposure:
- Qualify Test: 1 minute incubation
Categorisation Test: 1 minute incubation
Classification Test: >60 minutes - Observation period:
- not applicable
- Number of animals:
- not applicable
- Details on study design:
- CHEMICAL DETECTION SYSTEM (CDS)
Corrosive substances are able to disrupt the integrity of the bio-barrier, leading to penetration of the test item through the bio-barrier into the CDS located beneath. The presence of the test item in the CDS results in a colour change that is detected visually. The time it takes a test item to penetrate the bio-barrier into the CDS is inversely proportional to its corrosivity: the more corrosive the test item is, the shorter time required affects a colour change. Non-corrosive test items do not disrupt the bio-barrier, or disrupt the bio-barrier too slowly to be identified as corrosive.
PREPARATION OF THE BIO-BARRIER
Preparation of the synthetic macromolecular bio-barrier matrix (Corrositex TM test kit, Lot no. CT101408, Transia GmbH, 61239 Ober-Mörlen) was completed one day prior to testing and stored at 4 - 8 °C until assay performance. The bio-barrier powder was solved in the bio-barrier diluent and heated for 20 2 minutes at 68 – 70 °C in a water bath under continuous stirring. The temperature did not exceed 70 °C. The mixture was allowed to cool in the turned-off water bath for another 10 minutes. The mixture was then filled into the membrane holders, 200 µL per membrane holder. Air bubbles were avoided. The filled membrane holders were sealed with parafilm and were stored at 4 – 8 °C until further use.
QUALIFY TEST
In order to assess whether the test system is suitable for the test item, approx. 100 mg of test item were applied into the “Qualify Test Vial”. The vial was shaken until the solution appeared homogenous, and incubated for at least 1 minute. Afterwards, the colour change was noted. Since a change in colour was visible in the “Qualify Test Vial”, the test item was considered to be suitable for the next step.
CATEGORISATION TEST
Approx. 100 mg of test item were applied into the “Category A Vial” as well as into the “Category B Vial”. The vials were shaken until the solution appeared homogenous. After at least one minute the colour change was monitored. Based on the colour change obtained, a test item is assigned to a category. If an intense colour change (similar to the category 1 colour chart) is observed in “Category A Vial” or in “Category B Vial” the test item is assigned to category 1. If a less intense colour change is observed (similar to the category 2 colour chart) is observed in “Category A Vial” or in “Category B Vial” the test item will be assigned to category 2. If no colour change is observed in either of the vials, a confirmation test is conducted. For the confirmation test two drops of the confirm reagent are added to the “Category B Vial”. The vial would be shaken for 5 seconds. The colour of the solution would match one of the colours shown in the accompanying colour chart, confirming that the test item is a category 2 substance.
CLASSIFICATION TEST
7 vials containing the CDS were pre-warmed to room temperature. 4 vials were used for quadruplicate measurement of the test item, the vial labelled (+) was used for the positive control (single measurement, Sulfuric acid 95-98%), and the vial labelled (-) was used for the negative control (single measurement, Citric acid (10% solution in deionised water)). The vial labelled C was used as colour reference for the CDS.
Application of the test item formulations and the controls was performed staggered to ensure accurate reaction times to be recorded.
The prepared bio-barriers were placed atop the CDS vials (not longer than 2 min prior to application) and approx. 500 mg of the test item or 500 µL of the controls, respectively, were applied per bio-barrier. Colour change or precipitation in the CDS solution were recorded in the raw data file.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- penetration time (in minutes)
- Remarks:
- Change in colour in the Chemical Detection System (CDS) solution
- Run / experiment:
- See details on "Details on Study Design" section
- Value:
- > 60
- Vehicle controls validity:
- valid
- Remarks:
- Qualify test: approx. 100 mg of test item applied into the "Qualify Test Vial". Vial shaken until solution appeared homogenous and incubated for at least 1 minute. Afterwards, the colour change was noted.
- Negative controls validity:
- valid
- Remarks:
- Classification test: vial labelled as (-). Single measurement, citric acid (10% solution in deionised water). Colour change in CDS solution was not observed after 60 minutes.
- Positive controls validity:
- valid
- Remarks:
- Classification test: vial labelled as (+). Single measurement, sulfuric acid -%. Colour change in CDS solution observed after 1.15 minutes.
- Remarks on result:
- other: Non corrosive to skin
- Remarks:
- No change in colour of CDS solution after > 60 minutes.
- Other effects / acceptance of results:
- The test item was classified as non corrosive.
Any other information on results incl. tables
Qualify Test
The test item induced a change in colour in the qualify test after 1 minute incubation. Since a change in colour was visible in the “Qualify Test Vial”, the test item was considered to be suitable for the categorisation test.
Categorisation Test
The test item induced a change in colour in the Category A vial but not in the Category B vial after 1 minute incubation. Therefore, a confirmation experiment did not have to be performed. Therefore, the test item was classified as category II.
Classification Test
Test Group |
Time to |
DOT Packing Group |
R-Sentence |
GHS |
Negative Control |
Colour change was not observed after 60 |
- |
- |
- |
Positive Control |
1.15 |
I |
R35 |
1A |
Test item |
> 60 |
Non corrosive |
- |
- |
Applicant's summary and conclusion
- Interpretation of results:
- other: non corrosive
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item Disodium titanate is non corrosive to skin.
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