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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 237-523-0 | CAS number: 13825-74-6
- 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
Bioaccumulation: aquatic / sediment
Administrative data
- Endpoint:
- bioaccumulation in aquatic species: fish
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Bioaccumulation study on target compound titanium oxide sulphate itself is technically not feasible as the substance is highly unstable in aqueous environment in the environmentally relevant pH range. Thus a read-across from supporting substance is being proposed by using the stable, final hydrolysis product titanium dioxide as test surrogate. No guideline followed, but well documented and well performed study; measured TiO2 concentrations during exposure period.
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxicity of titanium dioxide nanoparticles to rainbow trout (Oncorhynchus mykiss): Gill injury, oxidative stress, and other physiological effects
- Author:
- Federici G, Shaw BJ, Handy RD
- Year:
- 2 007
- Bibliographic source:
- PMID: 17727975, Aquatic Toxicology 84(4):415-30
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 850.1730 (Fish Bioconcentration Test)
- Deviations:
- yes
- Remarks:
- - No depuration phase, no kinetic determined
- Principles of method if other than guideline:
- A semi-static test system was used to expose rainbow trout to TiO2 nonoparticles in freshwater for up to 14 days. Deviating from the guideline sampling was restricted to two measurements at day 7 and 14 and thus no kinetic investigation was performed and no depuration phase included.
- GLP compliance:
- no
Test material
- Reference substance name:
- Titanium dioxide
- EC Number:
- 236-675-5
- EC Name:
- Titanium dioxide
- Cas Number:
- 13463-67-7
- IUPAC Name:
- dioxotitanium
- Reference substance name:
- Rutile (TiO2)
- EC Number:
- 215-282-2
- EC Name:
- Rutile (TiO2)
- Cas Number:
- 1317-80-2
- IUPAC Name:
- dioxotitanium
- Details on test material:
- - Name of test material (as cited in study report): Titanium dioxide
- Molecular formula (as other than submission substance): TiO2
- Molecular weight (as other than submission substance): 79.899 g/mol
- Smiles notation (as other than submission substance): [Ti](=O)=O
- InChl (as other than submission substance): InChI=1/2O.Ti/rO2Ti/c1-3-2
- Structural formula attached as image file (as other than submission substance): O=Ti=O
Powder form of ultrafine titanium dioxide nanoparticles from DeGussa AG (UK), P25 TiO2 type.
Manufacturer's information: crystal structure of 75% rutile and 25% anatase TiO2 purity was at least 99% TiO2 (maximum impurity was 1% Si) average particle size was 21 nm with a specific surface area of 50±15 m²/g
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
JUSTIFICATION FOR READ ACROSS
Bioaccumulation study on target compound titanium oxide sulphate itself is technically not feasible as the substance is highly unstable in aqueous environment in the environmentally relevant pH range. Thus a read-across from supporting substance is being proposed by using the stable, final hydrolysis product titanium dioxide as surrogate.
In the present study the water was spiked with the test surrogate titanium dioxide. In conclusion the test was conducted with the relevant transformation product. The other final hydrolysis product sulphuric acid is considered irrelevant, as pH effects should be excluded according to the relevant test guidelines, and sulphate is not bioaccumulating. - Radiolabelling:
- no
Sampling and analysis
- Details on sampling:
- No data
Test solutions
- Vehicle:
- no
- Details on preparation of test solutions, spiked fish food or sediment:
- A stock solution of 10 g/L TiO2 was prepared by dispersing the nanoparticles in ultrapure water.
Test organisms
- Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Details on test organisms:
- Juvenile rainbow trout (n=189) were obtained from Hatchlands Trout Farm, Rattery, Devon.
Fish weighing 28.1 ± 0.4 g.
Stock animals were fed to satiation on a commercial trout food before the test.
Study design
- Route of exposure:
- aqueous
- Test type:
- semi-static
- Water / sediment media type:
- natural water: freshwater
- Total exposure / uptake duration:
- 14 d
Test conditions
- Hardness:
- 50 mg CaCO3/L
- Test temperature:
- 14 ± 1 °C
- pH:
- 7.11 ± 0.01
- Dissolved oxygen:
- Oxygen saturation: 87.0 ± 0.25 %
- Details on test conditions:
- 12 experimental glass aquaria: 3 tanks/treatment, 14 fish/tank.
Semi-static exposure regime: 80 % water change every 12h with re-dosing after each change.
Photoperiod was 12 h light: 12 h dark.
Fish were not fed 24 h prior to or during the experiment. Except for day 10, just after water change and prior to re-dosing with TiO2, to minimise aggressive behaviour associated with hunger. The food was consumed by the fish immediately without leaving residues. - Nominal and measured concentrations:
- In order to achieve working concentrations of 0 (control), 0.1, 0.5 and 1.0 mg/L TiO2 in the fish tanks, each tank was dosed with 0, 0.2, 1.0 or 2.0 ml of the 10 g stock solution, respectively. Measured TiO2 concentrations after dosing the tanks were 95, 98 and 97 % of the nominal target values for the 0.1, 0.5 and 1.0 mg TiO2/L treatments, respectively. Before the 12 h water change, measured concentrations were 89, 85 and 86 % of the nominal values for the 0.1, 0.5 and 1.0 mg/L TiO2 treatments, respectively. Nominal values are used for calculation of BCF values.
- Reference substance (positive control):
- not required
- Details on estimation of bioconcentration:
- No data
Results and discussion
Bioaccumulation factoropen allclose all
- Type:
- BCF
- Value:
- 19 - 208 L/kg
- Basis:
- organ d.w.
- Remarks:
- liver
- Calculation basis:
- other: after 14 d
- Remarks on result:
- other: Ti concentration in liver: 11.5-13.0 mg Ti/kg dw. BCF decreases with increasing TiO2 dose in water.
- Remarks:
- Conc.in environment / dose:0.1-1.0 mg TiO2/L
- Type:
- BCF
- Value:
- 26 - 272 L/kg
- Basis:
- organ d.w.
- Remarks:
- muscle
- Calculation basis:
- other: after 14 d
- Remarks on result:
- other: Ti concentration in muscle: 15.8-17.3 mg Ti/kg dw. BCF decreases with increasing TiO2 dose in water.
- Remarks:
- Conc.in environment / dose:0.1-1.0 mg TiO2/L
- Type:
- BCF
- Value:
- 34 - 352 L/kg
- Basis:
- organ d.w.
- Remarks:
- brain
- Calculation basis:
- other: after 14 d
- Remarks on result:
- other: Ti concentration in brains: 20.2-21.1 mg Ti/kg dw. BCF decreases with increasing TiO2 dose in water.
- Remarks:
- Conc.in environment / dose:0.1-1.0 mg TiO2/L
- Type:
- BCF
- Value:
- 20 - 200 L/kg
- Basis:
- organ d.w.
- Remarks:
- gills
- Calculation basis:
- other: after 14 d
- Remarks on result:
- other: Ti concentration in gills: 12.0-15.4 mg Ti/kg dw. BCF decreases with increasing TiO2 dose in water.
- Remarks:
- Conc.in environment / dose:0.1-1.0 mg TiO2/L
- Details on kinetic parameters:
- No dta
- Metabolites:
- Not applicable
- Results with reference substance (positive control):
- Not applicable
- Details on results:
- Tissue Ti concentrations in control media after 14 days:
Gill: 13.9 mg Ti/kg d.w.
Liver: 12.5 mg Ti/kg d.w.
Muscle: 18.7 mg Ti/kg d.w.
Brain: 22.5 mg Ti/kg d.w. - Reported statistics:
- No recalculation of the measured BCF is required as the test surrogate TiO2 results from isomolar transformation of the target chemical TiOSO4.
Any other information on results incl. tables
Conc. in environment / dose | Type | Value | Basis | Calculation basis | Remarks |
---|---|---|---|---|---|
0.1 mg TiO2/L | BCF | 280 | organ d.w. gill | after 7 d | Concentration organism: 16.8 mg Ti/kg dw |
0.5 mg TiO2/L | BCF | 51 | organ d.w. gill | after 7 d | Concentration organism: 15.4 mg Ti/kg dw |
1.0 mg TiO2/L | BCF | 27 | organ d.w. gill | after 7 d | Concentration organism: 16.3 mg Ti/kg dw |
0.1 mg TiO2/L | BCF | 200 | organ d.w. gill | after 14 d | Concentration organism: 12.0 mg Ti/kg dw |
0.5 mg TiO2/L | BCF | 51 | organ d.w. gill | after 14 d | Concentration organism: 15.4 mg Ti/kg dw |
1.0 mg TiO2/L | BCF | 20 | organ d.w. gill | after 14 d | Concentration organism: 12.0 mg Ti/kg dw |
0.1 mg TiO2/L | BCF | 144 | organ d.w. liver | after 7 d | Concentration organism: 8.6 mg Ti/kg dw |
0.5 mg TiO2/L | BCF | 30 | organ d.w. liver | after 7 d | Concentration organism: 9.1 mg Ti/kg dw |
1.0 mg TiO2/L | BCF | 15 | organ d.w. liver | after 7 d | Concentration organism: 9.1 mg Ti/kg dw |
Conc. in environment / dose | Type | Value | Basis | Calculation basis | Remarks |
---|---|---|---|---|---|
0.1 mg TiO2/L | BCF | 208 | organ d.w. liver | after 14 d | Concentration organism: 12.5 mg Ti/kg dw |
0.5 mg TiO2/L | BCF | 43 | organ d.w. liver | after 14 d | Concentration organism: 13.0 mg Ti/kg dw |
1.0 mg TiO2/L | BCF | 19 | organ d.w. liver | after14 d | Concentration organism: 11.5 mg Ti/kg dw |
0.1 mg TiO2/L | BCF | 272 | organ d.w. muscle | after 7 d | Concentration organism: 16.3 mg Ti/kg dw |
0.5 mg TiO2/L | BCF | 58 | organ d.w. muscle | after 7 d | Concentration organism: 17.3 mg Ti/kg dw |
1.0 mg TiO2/L | BCF | 24 | organ d.w. muscle | after 7 d | Concentration organism: 14.4 mg Ti/kg dw |
0.1 mg TiO2/L | BCF | 272 | organ d.w. muscle | after 14 d | Concentration organism: 16.3 mg Ti/kg dw |
0.5 mg TiO2/L | BCF | 58 | organ d.w. muscle | after 14 d | Concentration organism: 17.3 mg Ti/kg dw |
1.0 mg TiO2/L | BCF | 26 | organ d.w. muscle | after 14 d | Concentration organism: 15.8 mg Ti/kg dw |
Conc. in environment / dose | Type | Value | Basis | Calculation basis | Remarks |
---|---|---|---|---|---|
0.1 mg TiO2/L | BCF | 160 | organ d.w. brain | after 7 d | Concentration organism: 9.6 mg Ti/kg dw |
0.5 mg TiO2/L | BCF | 46 | organ d.w. brain | after 7 d | Concentration organism: 13.9 mg Ti/kg dw |
1.0 mg TiO2/L | BCF | 14 | organ d.w. brain | after 7 d | Concentration organism: 8.2 mg Ti/kg dw |
0.1 mg TiO2/L | BCF | 352 | organ d.w. brain | after 14 d | Concentration organism: 21.1 mg Ti/kg dw |
0.5 mg TiO2/L | BCF | 67 | organ d.w. brain | after 14 d | Concentration organism: 20.2 mg Ti/kg dw |
1.0 mg TiO2/L | BCF | 34 | organ d.w. brain | after 14 d | Concentration organism: 20.2 mg Ti/kg dw |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- not applicable
- Conclusions:
- Steady state BCF values of 200-272 at 0.1 mg/L and 20-26 at 1 mg/L were measured in gills and muscles respectively. BCF values of 208-352 at 0.1 mg/L and 19-34 at 1 mg/L were found in liver and brain. The BCF values are well below trigger levels for classification issues or the PBT discussion.
- Executive summary:
Bioaccumulation study on target compound titanium oxide sulphate itself is technically not feasible as the substance is highly unstable in aqueous environment in the environmentally relevant pH range. Thus a read-across from supporting substance is being proposed by using the stable, final hydrolysis product titanium dioxide as test surrogate.
In the present study the water was spiked with the test surrogate titanium dioxide. In conclusion the test was conducted with the relevant transformation product. The other final hydrolysis product sulphuric acid is considered irrelevant, as pH effects should be excluded according to the relevant test guidelines, and sulphate is not bioaccumulating.
The study investigates the enrichment of titanium species in fish (Oncorhynchus mykiss). The test was not performed under GLP and no technical guidance protocol applied. Nonetheless the study is sufficiently documented and comparable to U.S. EPA OPPTS 850.1730 standards. The experiments are considered valid and conclusive.
The titanium concentrations in the various fish tissues were constant over the concentration range. The resulting BCFs were 200-20 (gills), 272-26 (muscle), 208-19 (liver), and 352-34 (brain). The data show clearly the decreasing BCF with increasing TiO2 concentrations in the aqueous medium. The effect mainly can be explained by the very limited water solubility of TiO2 at around neutral pH, which has been shown to be in the low µg/L range. Subsequently the effectively bioavailable, dissolved Ti concentration can safely be assumed to be largely the same for all TiO2 concentration levels tested in this study (i.e. 0.1, 0.5, and 1.0 mg/l TiO2). In all cases the determined BCF values were found such in an order of magnitude which poses no reason of concern (e.g. threshold value for BCF = 2000 L/kg for triggering PBT discussion or classification issues).
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.