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EC number: 234-679-1 | CAS number: 12023-27-7
- 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
Toxicity to microorganisms
Administrative data
Link to relevant study record(s)
- Endpoint:
- activated sludge respiration inhibition testing
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is highly insoluble in water, hence indicating that aquatic toxicity is unlikely to occur
- Endpoint:
- activated sludge respiration inhibition testing
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- For Read-Across Justification please refer to Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Duration:
- 30 min
- Dose descriptor:
- EC50
- Effect conc.:
- > 20 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: luminescence inhibition
- Duration:
- 30 min
- Dose descriptor:
- NOEC
- Effect conc.:
- > 20 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: luminescence inhibition
- Endpoint:
- toxicity to microorganisms, other
- Remarks:
- Flash assay with Vibrio fisheri
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- not specified
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Principles of method if other than guideline:
- A Flash Assay was performed. In this assay the luminescence inhibition to V. fischeri kinetic was assessed taking into account the color and turibidity (measured using a Luminometer controlled by Multiuse software). The luminescence was measured every 0.05 g under continuous mixing at ambient temperature (20℃). The test item was diluted and tested in 2% NaCl.
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Titanium dioxide (bulk)
- Substance type: particle
- Source: Riedel-de Haen - Analytical monitoring:
- not specified
- Details on sampling:
- Not specified
- Vehicle:
- not specified
- Details on test solutions:
- Not specified
- Test organisms (species):
- Vibrio fisheri
- Test type:
- other: Flash assay
- Water media type:
- not specified
- Limit test:
- no
- Total exposure duration:
- 30 min
- Post exposure observation period:
- Not applicable
- Hardness:
- Not specified
- Test temperature:
- Not specified
- pH:
- Not specified
- Dissolved oxygen:
- Not specified
- Salinity:
- Not specified
- Conductivity:
- Not specified
- Nominal and measured concentrations:
- Not specified
- Details on test conditions:
- Not specified
- Reference substance (positive control):
- not specified
- Duration:
- 30 min
- Dose descriptor:
- EC50
- Effect conc.:
- > 20 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: luminescence inhibition
- Duration:
- 30 min
- Dose descriptor:
- NOEC
- Effect conc.:
- > 20 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: luminescence inhibition
- Details on results:
- The test item suspension was not acutely toxic up to and including 20 g/L level.
- Results with reference substance (positive control):
- Not specified
- Reported statistics and error estimates:
- EC50 values were calculated using Biotox software (Thermo Lab systems, Helsinki, Finland)
- Validity criteria fulfilled:
- not specified
- Conclusions:
- The 30-min EC50 and NOEC were determined to be higher than 20 g/L in nominal.
- Executive summary:
In a Flash assay with Vibrio fischeri the 30-min EC50 and NOEC were determined to be higher than 20000 mg/L (nominal).
- Endpoint:
- activated sludge respiration inhibition testing
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- For Read-Across Justification please refer to Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Dose descriptor:
- EC50
- Effect conc.:
- >= 500 - <= 1 000 other: ppm
- Basis for effect:
- growth inhibition
- Remarks:
- B. subtilis
- Remarks on result:
- other: not further specified
- Dose descriptor:
- EC50
- Effect conc.:
- > 2 000 - <= 5 000 other: ppm
- Basis for effect:
- growth inhibition
- Remarks:
- E. coli
- Remarks on result:
- other: not further specified
- Endpoint:
- toxicity to microorganisms, other
- Remarks:
- not further specified
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- not specified
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Principles of method if other than guideline:
- Petri dishes filled with liquid MD media were supplemented with nanoparticle suspensions (final volume of 5 mL). The plates were inoculated with cultures of B. subtilis or E.coli and incubated overnight. Control plates containing MD medium and bacteria were sealed with Parafilm. Cultures were diluted to achieve cell concentration of approximately 103 CFU/mL, spread onto LB plates (in duplicates, three test runs), and left to grow at 36℃ for 14-20h. Colonies were counted and compared to control plates to calculate percentage growth inhibition.
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- - Name of test material: Titanium dioxide
- Particle size: 44 µm (powder)
- Purchase: Sigma-Aldrich (St. Louis, MO, USA) - Analytical monitoring:
- not specified
- Details on sampling:
- not specified
- Vehicle:
- not specified
- Details on test solutions:
- not specified
- Test organisms (species):
- other: Bacillus subtilis and Escherichia coli
- Details on inoculum:
- not applicable
- Test type:
- not specified
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 20 h
- Remarks on exposure duration:
- 14-20h
- Post exposure observation period:
- None
- Hardness:
- not applicable
- Test temperature:
- 23℃
- pH:
- not specified
- Dissolved oxygen:
- not applicable
- Salinity:
- not applicable
- Conductivity:
- not applicable
- Nominal and measured concentrations:
- not specified
- Details on test conditions:
- - Sunlight for 6h(9 AM to 3 PM)-UV Index 6-7
- Reference substance (positive control):
- not specified
- Dose descriptor:
- EC50
- Effect conc.:
- >= 500 - <= 1 000 other: ppm
- Basis for effect:
- growth inhibition
- Remarks:
- B.subtilis
- Remarks on result:
- other: not further specified
- Dose descriptor:
- EC50
- Effect conc.:
- > 2 000 - < 5 000 other: ppm
- Basis for effect:
- growth inhibition
- Remarks:
- E. coli
- Remarks on result:
- other: not further specified
- Validity criteria fulfilled:
- not specified
- Conclusions:
- The EC50 for B. subtilis and E. coli were determined to be 500~1000 and 2000-5000 ppm, respectively.
Referenceopen allclose all
Table 1. The toxicity (30min EC50 and NOEC) of titanium dioxide to Vibrio fischeri.
Chemical |
Toxicity to Vibrio fischeri |
|
TiO2 |
EC50+/- SD |
NOEC |
>20000 |
>20000 |
Table 1. Percentage growth inhibition to B. subtilis and E. coli at various concentrations.
Treatment |
Percentage growth inhibition at various concentrations |
|||||||
10ppm |
50 ppm |
100 ppm |
500 ppm |
1000 ppm |
2000 ppm |
5000 ppm |
||
B.subtilis |
TiO2330nm |
n.d |
0 |
0 |
0 |
75 +/-6.6 |
99 +/-0.9 |
n.d |
E.coli |
TiO2330nm |
n.d |
0 |
0 |
15 +/-4.2 |
44 +/-7.0 |
46 +/-11.3 |
72 +/-9.4 |
n.d: not determined
Description of key information
The study on toxicity to microorganisms with diiron titanium pentaoxide does not need to be conducted because the substance is highly insoluble in water, hence indicating that aquatic toxicity is unlikely to occur (study scientifically not necessary). However, by applying an analogue approach the EC50 for the target substance was determined to be 1000 mg/L.
Key value for chemical safety assessment
- EC50 for microorganisms:
- 1 000 mg/L
Additional information
Non submission justification for diiron titanium pentaoxide
Data on toxicity of Diiron titanium pentaoxide to aquatic microorganisms is not available. The substance was assessed in three guideline studies to be highly insoluble in water (references 4.8-2, 4.8-3 and 4.8-1). In a worst case approach the water solubility of the test item was determined to be 2.715 µg/L at a temperature of 20 °C (please refer to the endpoint summary in IUCLID section 4.8). Toxic effects to aquatic microorganisms are hence unlikely. Therefore, in accordance with the criteria given in column 2 of Annex VIII to Regulation (EC) No 1907/2006 (REACH), the study on toxicity to aquatic microorganisms is considered scientifically not necessary and was waived.
Nevertheless, available data for the read across source substances titanium dioxide (CAS 13463-67-7) and diiron trioxide (CAS 1309-37-1) are summarized below.
Titanium dioxide
In a Flash assay with Vibrio fischeri the 30-min EC50 and NOEC were determined to be higher than 20000 mg/L (nominal) (reference 6.1.7 -1).
In another in vitro test the EC50 for Bacillus subtilis and Escherichia coli were found to be 500~1000 and 2000-5000 ppm, respectively (reference 6.1.7 -2).
Key information on toxicity to microorganisms provided in public ECHA REACH dossiers for the read across substances titanium dioxide and diiron trioxide
Titanium dioxide
According to the public ECHA REACH dossier on titanium dioxide (last accessed on: 18 March 2020) dispersions of nano- and microsized titanium dioxide do not inhibit microbial respiration in activated sewage sludge up to 1000 mg/L.
Diiron trioxide
In the public ECHA REACH dossier on diiron trioxide (last accessed on: 18 March 2020) a 3-hour EC50 of > 10000 mg/L was used as key value regarding the toxicity to aquatic microorganisms.
Conclusion
Based on the physico-chemical properties of diiron titanium pentaoxide a test on toxicity to aquatic microorganisms is scientifically not justified in accordance with column 2 of Annex VIII to Regulation (EC) No 1907/2006 (REACH). Moreover, the source substances titanium dioxide (CAS 13463-67-7) and diiron trioxide (CAS 1309-37-1) are found to be non-toxic to aquatic microorganisms. Target and source substance are metal-containing inorganic oxides. The target substance diiron titanium pentaoxide is a mixed oxide of titanium dioxide and diiron trioxide. The source substances share the common atoms Ti, O and Fe with the target substance and have very similar physicochemical properties (for further information please refer to the read across justification attached to IUCLID section 13). Therefore, by applying an analogue approach, diiron titanium pentaoxide is not considered to be toxic to aquatic microorganisms and additional studies are scientifically not necessary. Following a weight of evidence approach the EC50 of the target substance is determined to be 1000 mg/L.
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.
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