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EC number: 234-802-9 | CAS number: 12034-34-3
- 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:
- 2010-03-30 to 2010-03-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study reliable without restrictions
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:
- other: OECD Guideline for Testing of Chemicals 437: Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants, September, 2009
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: INVITTOX (UK) protocol no. 98 “The Bovine Corneal Opacity and Permeability Assay”, February 1994
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Bovine Corneal Opacity and Permeability (BCOP) Assay, SOP of Microbiological Associates Ltd., UK, Procedure Details, April 1997
- 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:
- Na2O3Ti
- IUPAC Name:
- disodium oxotitaniumbis(olate)
- 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 / tissue source
- Details on test animals or tissues and environmental conditions:
- Not applicable - Since this is a in vitro study there is no information on test animals.
Test system
- Vehicle:
- physiological saline
- Remarks:
- 0.9% (w/v) NaCl in deionised water
- Amount / concentration applied:
- Prior to the application of 0.75 mL the test item was suspended in saline (20% (w/v))
- Duration of treatment / exposure:
- Opacity measurement: incubation time: 240 min (+/- 5min)
Permeability of the corneae: 90 min - Observation period (in vivo):
- not applicable
- Number of animals or in vitro replicates:
- not applicable
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the test item was rinsed off from the application side by changing cMEM three times.
- Time after start of exposure: 240 min (+/- 5 min)
SCORING SYSTEM:
The following formula was used to determine the in vitro score of the negative control:
In vitro Score = opacity value + (15 x OD490 value)
The following formula was used to determine the in vitro score of the positive control and the test item:
In vitro Score = (opacity value – opacity value mean negative control) + (15 x corrected OD490 value)
The in vitro score was calculated for each individual treatment and positive control cornea. The mean in vitro score value of each treated group was calculated from the individual in vitro score values.
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Mean in vitro Score
- Basis:
- other: Negative Control
- Time point:
- other: 240 minutes
- Score:
- 1.84
- Irritation parameter:
- other: Mean in vitro Score
- Basis:
- other: Positive control
- Time point:
- other: 240 minutes
- Score:
- 155.94
- Irritation parameter:
- other: Mean in vitro Score
- Basis:
- other: Test item
- Time point:
- other: 240 minutes
- Score:
- -0.26
- Irritant / corrosive response data:
- The test item Disodium titanate did not cause any opacity or permeability of the corneae compared with the results of the negative control. The calculated mean in vitro score was – 0.26 and therefore, the test item was classified as non eye irritant.
Any other information on results incl. tables
Results
Results after 240 Minutes Incubation Time
Test Group |
Opacity value = Difference (t240-t0) of Opacity* |
Permeability at 490 nm (OD490)* |
In vitro Score |
Mean in vitro Score |
Proposed in vitro Irritation Scale |
||
|
|
Mean |
|
Mean |
|
|
|
Negative Control |
1 |
1.00 |
0.059 |
0.056 |
1.89 |
1.84 |
Non eye irritant |
2 |
0.054 |
2.81 |
|||||
0 |
0.054 |
0.81 |
|||||
Positive Control |
153.00* |
0.733* |
164.00 |
155.94 |
Severe eye irritant |
||
160.00* |
0.322* |
164.84 |
|||||
134.00* |
0.332* |
138.99 |
|||||
Disodium titanate |
- 1.00* |
- 0.008* |
- 1.12 |
- 0.26 |
Non eye irritant |
||
- 1.00* |
- 0.002* |
- 1.03 |
|||||
1.00* |
0.024* |
1.37 |
Historical Data
|
Positive Control |
Negative Control |
Mean |
137.19 |
2.22 |
Standard Deviation |
34.87 |
0.47 |
Values of 36 studies with solid test items performed in 2008 and 2009
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information 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 not considered to be an eye irritant.
- Executive summary:
The test item Disodium titanate did not cause any opacity or permeability of the corneae compared with the results of the negative control.
The calculated mean in vitro score was – 0.26 and therefore, the test item was classified as non eye irritant.
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