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EC number: 308-551-1 | CAS number: 98072-94-7 Natural ilmenite ore is concentrated by selective removal of impurities, chiefly iron, to yield a product enriched in titanium dioxide. The process consists of an optional oxidative roast followed by a reductive roasting stage, an acidic leaching stage and washing and drying the product. Alternatively the process consists of selectively chlorinating the iron oxide present in the reduced ore.
- 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
Endpoint summary
Administrative data
Description of key information
No reliable results are available for repeated dose toxicity of synthetic rutile. Therefore, read-across is proposed to available data on TiO2.
Titanium dioxide did not show adverse effects in a chronic oral repeated dose toxicity study in rats with a NOAEL of 3500mg/kg bw/day.
Titanium dioxide is not absorbed to any relevant extent through human skin, thus no toxic effects can be expected via the dermal route of exposure.
Synthetic rutile is not inhalable at any relevant extent, thus conduct of repeated dose toxicity studies via the inhalation route is considered dispensable.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 3 500 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
Additional information
Read across concept
Synthetic rutile consists primarily of a titanate phase (solid solution) most of which is titanium in an oxidised form. Upon ingestion, a low rate of dissolution in the GI tract is assumed, based on the experimental verified inertness of the material. Any material being released from Synthetic rutile under physiological conditions will be in the form of ionic titanium, which is similarly the case for titanium dioxide, thus read-across from repeated dose oral toxicity data on titanium dioxide is considered feasible without any restrictions.
Furthermore, transformation/dissolution testing according to “OECD 29 Environmental Health and Safety Publications, Series on testing and assessment, Guidance document on transformation/ dissolution of metals and metal compounds in Aqueous media” has shown that synthetic rutile compared to titanium dioxide has a similar release rate of titanium ions (please refer to the respective entry under the endpoint water solubility).
Repeated dose toxicity, oral
Male and female F344 rats (8-weeks old, 50 animals per group) were fed a diet containing 2% corn oil and 25,000 or 50,000 ppm titanium dioxide for 103 weeks (7 days per week). Groups of male and female B6C3F1 mice (36 days old, 50 animals per group) were fed analogously. With the exception of white faeces, there was no other clinical sign that was judged to be related to titanium dioxide exposure (for detailed information please refer to the endpoint study records reported under section carcinogenicity).
In a 28 -days study male rats were exposed by oral gavage for 29 days to 24,000 mg/kg titanium dioxide particles (test items: H-27201, H-27203), or the vehicle. Under the conditions of this study, the no-observed-effect level for titanium dioxide was 24,000 mg/kg/day for male rats, based on the lack of any adverse effects at this dose.
Repeated dose toxicity, dermal
Titanium dioxide was tested in various percutaneous absorption tests which have been reviewed by the Scientific Committee on cosmetic products and non-food products (SCCNFP/0005/98, 2000) and which concluded “extensive tests for percutaneous absorption, mostly in vitro, indicate that absorption does not occur, either with coated or uncoated material; one experiment found some evidence that a little of the material could be found in the openings of the follicles. [...] The toxicological profile of this material does not give rise to concern in human use, since the substance is not absorbed through the skin. In view, also, of the lack of percutaneous absorption, a calculation of the margin of safety has not been carried out.”
Repeated dose toxicity, inhalation
The conduct of a repeated dose toxicity study via inhalation is unjustified as inhalation of the substance is considered negligible, based on the outcome of the dustiness testing according to method EN 15051/ DIN 33897-2, as reported under section particle size distribution (granulometry). The results demonstrate that synthetic rutile has a limited ability to be inhaled by humans: 0.025 % of airborne material is estimated to be inhalable, whereas about 0.002 % or less of inhaled material is predicted to be deposited in the pulmonary region (PU), i.e. respirable fraction. The material deposited in the tracheobronchial (TB) and the extrathoracic region (Head) may be assumed to be cleared to the GI tract (i.e., by mucociliary escalation and subsequent swallowing).
For the reasons presented above, the conduct of a repeated dose toxicity study via inhalation is considered dispensable.
Justification for classification or non-classification
Repeated dose toxicity, oral
The reference National Cancer Institute (1979) is considered as the key study for repeated dose toxicity via oral application and will be used for classification. Rats were dosed at 3500 mg/kg bw/day orally via feed. Based on the lack of any adverse effects, the no observed adverse effect level (NOAEL) via oral application for titanium dioxide was established at 3500 mg/kg bw/day
(for detailed information please refer to the endpoint study records reported under section carcinogenicity).
The classification criteria according to regulation (EC) 1272/2008 as specific target organ toxicant (STOT) – repeated exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and the no observed adverse effect level (NOAEL) via oral application is above the guidance value for a Category 1 classification of 10 mg/kg bw/day and above the guidance value for a Category 2 classification of 100 mg/kg bw/day. For the reasons presented above, no classification for specific target organ toxicant (STOT) – repeated exposure, oral is required.
It is considered that these conclusions can be read across to Synthetic Rutile.
Repeated dose toxicity, dermal
Titanium dioxide was tested in various percutaneous absorption tests which have been reviewed by the Scientific Committee on cosmetic products and non-food products (SCCNFP/0005/98, 2000) and which concluded “extensive tests for percutaneous absorption, mostly in vitro, indicate that absorption does not occur, either with coated or uncoated material; one experiment found some evidence that a little of the material could be found in the openings of the follicles. [...] The toxicological profile of this material does not give rise to concern in human use, since the substance is not absorbed through the skin. In view, also, of the lack of percutaneous absorption, a calculation of the margin of safety has not been carried out.”
For the reasons presented above, no classification for specific target organ toxicant (STOT) – repeated exposure, dermal is required.
It is considered that these conclusions can be read across to Synthetic Rutile.
Repeated dose toxicity, inhalation
The conduct of a repeated dose toxicity study via inhalation is unjustified as inhalation of the substance is considered negligible, based on the outcome of the dustiness testing according to method EN 15051/ DIN 33897-2, as reported under section particle size distribution (granulometry). The results demonstrate that synthetic rutile has a limited ability to be inhaled by humans: 0.025 % of airborne material is estimated to be inhalable, whereas about 0.002 % or less of inhaled material is predicted to be deposited in the pulmonary region (PU), i.e. respirable fraction. The material deposited in the tracheobronchial (TB) and the extrathoracic region (Head) may be assumed to be cleared to the GI tract (i.e., by mucociliary escalation and subsequent swallowing).
For the reasons presented above, the conduct of a repeated dose toxicity study via inhalation is considered dispensable.
It is considered that these conclusions can be read across to Synthetic Rutile.
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