Registration Dossier
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: 235-120-4 | CAS number: 12070-08-5
- 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

Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- An Ames test with three hundred chemicals was performed applying the pre-incubation method.
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): Titanium dioxide
- Substance type: inorganic
- Physical state: solid
- Analytical purity: 98.5 %
Method
- Target gene:
- One of the genes comprising the his-operon involved in histidine synthesis
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA97, TA98, TA100, TA1535, TA1537
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Oxoid No. 2 broth; Vogel-Bonner medium (Vogel and Bonner, 1956) was used for the preincubation assay.
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: n.a.
- Periodically checked for karyotype stability: n.a.
- Periodically "cleansed" against high spontaneous background: n.a. - Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fractions of Aroclor 1254-induced
- Test concentrations with justification for top dose:
- The concentrations tested were reported as follows:
Each chemical was tested initially at half-log dose intervals up to a dose that elicited toxicity, or to a dose immediately below one which was toxic in the preliminary toxicity test. Subsequent trials occasionally used narrower dose increments and may not have included doses in the toxic range. Chemicals that were not toxic were tested, with few exceptions, to a maximum dose of 10 mg/plate. - Vehicle / solvent:
- Water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- other: 4-nitro-o-phenylenediamine; 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper disk
DURATION
- Preincubation period: The test chemical (0.05 ml), Salmonella culture (0.10 ml), and S-9 mix or buffer (0.50 ml) were incubated at 37°C, without shaking, for 20 min.
- Exposure duration: incubation time 2 days
- Expression time (cells in growth medium): same as exposure time
- Selection time (if incubation with a selection agent): same as exposure time;
- Fixation time (start of exposure up to fixation or harvest of cells): n.a.
SELECTION AGENT (mutation assays): absence of histidine;
SPINDLE INHIBITOR (cytogenetic assays): n.a.
STAIN (for cytogenetic assays): n.a.
NUMBER OF REPLICATIONS: no data
NUMBER OF CELLS EVALUATED: n.a.; the colonies able to grow on meidum lacking histidine were counted
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: cloning efficiency
OTHER EXAMINATIONS:
- Determination of polyploidy: n.a.
- Determination of endoreplication: n.a. - Evaluation criteria:
- The data were evaluated as described previously (Zeiger et al., 1987). Evaluations were made at both the individual trial and overall chemical levels. Individual trials were judged mutagenic ( +), weakly mutagenic ( +W), questionable (?), or nonmutagenic ( -), depending on the magnitude of the increase of his + revertants, and the shape of the dose-response.
- Statistics:
- no data
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA97, TA98, TA100, TA1535, TA1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Based on the results of an Ames test Titanium Dioxide is considered to be not a mutagenic substance. - Executive summary:
In a reverse gene mutation assay in bacteria, strains TA97, TA98, TA100, TA1535, and TA1537 ofS. typhimuriumwere exposed to altogether 300 chemical, among them Titanium Dioxide in concentrations not clearly specified. Each chemical was tested initially at half-log dose intervals up to a dose that elicited toxicity, or to a dose immediately below one which was toxic in the preliminary toxicity test. Subsequent trials occasionally used narrower dose increments and may not have included doses in the toxic range. Chemicals that were not toxic were tested to a maximum dose of 10 mg/plate. Each chemical was tested in the absence and in the presence of the metabolic activator S9 applying the pre-incubation method.
Appropriate positive and negative controls showed the expected responses in the corresponding strains.The results of a study from Dunkel et al. (1985) which are also cited by the NTP (National Toxicology Program) could be confirmed. Titanium Dioxide is not considered to be mutagenic in the Ames test.There wasno evidenceof induced mutant colonies over background reported.
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.

Route: .live1