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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
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- 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:
- short-term toxicity to fish
- 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
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- NOELR
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- no
- Principles of method if other than guideline:
- Positive control with Pentachlorophenol sodium salt performed in addition to blank control.
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Name: Titanium dioxide (bulk)
- Supplier : Sigma-Aldrich
- Lot No. : SZB90960
- Purity : 99.1%
- Appearance : White powder
- Storage condition : Room temperature - Analytical monitoring:
- yes
- Details on sampling:
- - Sampling method: 50 mL of filtered (0.45 μm PTFE membrane filter) and non-filtered samples were transferred into 100 mL beaker in triplicate, respectively
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Water Accomodated Fractions according to OECD guideline 23 (OECD, 2000)
- Stirring: 48 hours
- Settling period: 24 hours (suspension and precipitate
- Controls:
Negative control: groundwater without test item.
Positive control: 0.20, 0.30, 0.45, 0.68 and 1.01 mg/L (geometric series 1.5, nominal concentration) Pentachlorophenol sodium salt
- Evidence of undissolved material: No, highest test concentration of 100 mg/L evenly dispersed - Test organisms (species):
- Oryzias latipes
- Details on test organisms:
- TEST ORGANISM
- Common name: Ricefish (Oryzias latipes)
- Source: Health Care Research Laboratory, KTR (Korea)
- Age at study initiation: 3-4 months old
- Length at study initiation: 2.83 (+/-) 0.16 cm
- Weight at study initiation: 0.19 (+/-) 0.02 g
ACCLIMATION
- Acclimation period: 7 days
- Acclimation conditions: same as test
- Type and amount of food during acclimation: not specified
- Feeding frequency during acclimation: not fed 24 hours prior to test
- Health during acclimation: no mortality observed
FEEDING DURING TEST :
- Food type: Tetramin flake (Tetra Co. Germany) in the morning, Blood worm (Hikari sales USA Inc., USA) in the afternoon
- Amount: not specified
- Frequency: two times a day - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Post exposure observation period:
- None
- Hardness:
- 59.2 mg/L as CaCO3
- Test temperature:
- 23.0 °C (Min. 22.9 - Max. 23.1 °C)
- pH:
- 7.48 (Min. 7.33 - Max. 7.94)
- Dissolved oxygen:
- 6.81 mg/L (Min. 5.43 mg/L - Max. 8.09 mg/L)
- Salinity:
- Not applicable
- Conductivity:
- Not specified
- Nominal and measured concentrations:
- Nominal loading rate (mg/L): 0 (control), 100
Measured concentration:
0 h: 0.03 mg/L (non-filtered test solution), <0.02 mg/L (filtered test solution, 0.45 μm PTFE membrane filter)
48 h: 0.04 (non-filtered test solution), <0.02 mg/L (filtered test solution, 0.45 μm PTFE membrane filter)
96 h: 0.03 mg/L (non-filtered test solution), <0.02 mg/L (filtered test solution, 0.45 μm PTFE membrane filter) - Details on test conditions:
- TEST SYSTEM
- Test vessel: glass, cylindric glass bath, nominal volume: 12.5 L
- Fill volume: 10 L
- Aeration: not specified
- No. of organisms per vessel: 10
- No. of vessels per concentration: 1
- No. of vessels per control: 1
- Biomass loading rate: not specified
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Groundwater, filtered through 1.0 μm pre-filter and 0.2 μm micro-filter, aerated over 24 hours
- Culture medium different from test medium: no
- Intervals of water quality measurement: every 6 months; no alterating effects to test observed
OTHER TEST CONDITIONS
- Adjustment of pH: not specified
- Photoperiod: 16 hours light and 8 hours dark
- Light intensity: not specified
EFFECT PARAMETERS MEASURED: mortality and abnormal behavior
TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable (limit test)
- Range finding study: not reported - Reference substance (positive control):
- yes
- Remarks:
- Pentachlorophenol sodium salt
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- NOELR
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Behavioural abnormalities:
- Observations on body length and weight: no
- Other biological observations: no
- Mortality of control: no
- Other adverse effects control: no
- Abnormal responses: no
- Any observations that might cause a difference between measured and nominal values: not reported
- Effect concentrations exceeding solubility of substance in test medium: no (WAF performed) - Results with reference substance (positive control):
- Not reported
- Sublethal observations / clinical signs:
Table 1. Measured concentration by ICP-OES Analysis (Non-filtered)
Loading rate (mg/L)
Mean measured concentration (mg/L)
0-hour
48-hour
96-hour
Control
ND
ND
ND
100
0.03(+/-)0.00
0.04(+/-)0.01
0.03(+/-)0.01
*ND : Not detected
Table 2. Measured concentration by ICP-OES Analysis (Filtered)
Loading rate (mg/L)
Mean measured concentration (mg/L)
0-hour
48-hour
96-hour
Control
ND
ND
ND
100
< 0.02
< 0.02
< 0.02
*ND : Not detected, * 0.02 : Bottom limit of quantitation
Table 3. Cumulative mortality ofOryzias latipes
Loading rate (mg/L)
Number of organisms tested
Cumulative number of dead fish
24-hour
48-hour
72-hour
96-hour
Control
10
0
0
0
0
100
10
0
0
0
0
Table 4. Symptoms of intoxication of the test substance toOryzias latipes
Loading rate (mg/L)
Symptoms of Intoxication
24-hour
48-hour
72-hour
96-hour
Control
NOR
NOR
NOR
NOR
100
NOR
NOR
NOR
NOR
*NOR : Normal
- Validity criteria fulfilled:
- not specified
- Conclusions:
- In a GLP-compliant limit-test according to ECD Guideline 203 with Oryzias latipes (Ricefish) the 96-h LL50 and NOELR of titanium dioxide were determined to be >= 100 mg/L and 100 mg/L (nominal), respectively.
- Executive summary:
A 96-hour Fish, Acute Toxicity Test according to OECD Guideline 203 with titanium dioxide was performed under static conditions and in compliance with the GLP principles. Because of the very low water solubility of titanium dioxide the test solutions were prepared by using Water Accommodated Fractions in accordance with OECD Guideline 23 (2000). Ten fish (Oryzias latipes) were exposed to a limit loading rate of 100 mg test substance/L (1 replicate). In addition, a negative control (10 fish in 1 replicate) and a positive control with the reference substance Pentachlorophenol sodium salt were performed. The results of the test are expressed as loading rates: The 48- and 96-hour LL50 was determined to be >= 100 mg/L. The 48- and 96-hour NOELR was found to be 100 mg/L.
- Endpoint:
- short-term toxicity to fish
- 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:
- 96 h
- Dose descriptor:
- other: TL50
- Effect conc.:
- > 1 000 mg/L
- Conc. based on:
- other: Salinity 5.0 ppt
- Duration:
- 96 h
- Dose descriptor:
- other: TL50
- Effect conc.:
- > 1 000 mg/L
- Conc. based on:
- other: Salinity 25.3 ppt
- Endpoint:
- short-term toxicity to fish
- 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:
- not further specified
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- not specified
- Analytical monitoring:
- not specified
- Details on sampling:
- not specified
- Vehicle:
- not specified
- Details on test solutions:
- not specified
- Test organisms (species):
- Fundulus heteroclitus
- Details on test organisms:
- TEST ORGANISM
- Source: wild cought collected with seines from waters with salinities in excess of 17 ppt (New Jersey, included Shark River, Shrewsbury River and Horseshoe Cove at Sandy Hook)
- Weight at study initiation: 2.7 g (range 1.1 -6.0)
ACCLIMATION
- Acclimation period: not specified
- Acclimation conditions: not specified
- Type and amount of food during acclimation: not specified
- Feeding frequency during acclimation: not specified
- Health during acclimation: not specified
QUARANTINE
- Duration: not specified
- Health/mortality: not specified
FEEDING DURING TEST
- Food type: not specified
- Amount: not specified
- Frequency: not specified - Test type:
- not specified
- Water media type:
- saltwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Post exposure observation period:
- not specified
- Hardness:
- not specified
- Test temperature:
- 20 °C
- pH:
- not specified
- Dissolved oxygen:
- not specified
- Salinity:
- low (3 to 8 ppt) and high (17 to 23 ppt)
- Conductivity:
- not specified
- Nominal and measured concentrations:
- nominal: 1000 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: not specified
- Material, size, headspace, fill volume: not specified
- Aeration: not specified
- Renewal rate of test solution: not specified
- No. of organisms per vessel: 3
- No. of vessels per concentration: 3
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: not specified
OTHER TEST CONDITIONS
- Adjustment of pH: not specified
- Photoperiod: not specified
- Light intensity: not specified
EFFECT PARAMETERS MEASURED: not specified
TEST CONCENTRATIONS : not specified - Reference substance (positive control):
- not specified
- Duration:
- 96 h
- Dose descriptor:
- other: TL50
- Effect conc.:
- > 1 000 mg/L
- Conc. based on:
- other: Salinity 5.0 ppt
- Duration:
- 96 h
- Dose descriptor:
- other: TL50
- Effect conc.:
- > 1 000 mg/L
- Conc. based on:
- other: Salinity 25.3 ppt
- Details on results:
- not reported
- Results with reference substance (positive control):
- not specified
- Reported statistics and error estimates:
- not reported
- Validity criteria fulfilled:
- not specified
- Conclusions:
- In an acute in vivo toxicity test with Fundulus heteroclitus (wild caught) the 96-hour TL50 (median tolerance limit) of the test item at low (5.0 ppt ) and high (25.3 ppt) salinity levels was determined to be >1000 mg/L.
- Endpoint:
- short-term toxicity to fish
- 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:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Endpoint:
- short-term toxicity to fish
- 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- - Name: ultrafine TiO2
- Analytical monitoring:
- not specified
- Details on sampling:
- not specified
- Vehicle:
- not specified
- Details on test solutions:
- not specified
- Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Details on test organisms:
- not specified
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Post exposure observation period:
- not specified
- Hardness:
- not specified
- Test temperature:
- 12.1-12.5 °C
- pH:
- not specified
- Dissolved oxygen:
- not specified
- Salinity:
- not sapplicable
- Conductivity:
- not specified
- Nominal and measured concentrations:
- nominal concentrations: 0.1, 1.0, 10, and 100 mg/L
- Details on test conditions:
- not reported
- Reference substance (positive control):
- not specified
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Details on results:
- After 96 hours no mortality observed, neither in control nor at test item concentrations of 0.1, 1.0, 10, and 100 mg/L.
- Results with reference substance (positive control):
- not specified
- Reported statistics and error estimates:
- not reported
- Validity criteria fulfilled:
- not specified
- Conclusions:
- In a static Fish, Acute Toxicity Test according to OECD Guideline 203 with Oncorhynchus mykiss the 96 hour LC50 for the test item was determined to be higher than 100 mg/L.
Referenceopen allclose all
Description of key information
A study on short-term toxicity 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, following an analogue approach a 96-hour LC50 of >= 100 mg/L was determined.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 100 mg/L
Additional information
Non-submission justification
No study data for the registration substance diiron titanium pentaoxide are available. The substance was assessed in three guideline studies to be sparingly soluble 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). Furthermore, the maximum of the mono-modal particle size distribution was observed at approximately between 10 µm and 20 µm. The D10, D50 and D90 percentile were determined as L10 = 7.07 µm, L50 = 13.1 µm and L90 = 22.9 µm, respectively. Considering these physico-chemical properties, diiron titanium dioxide is unlikely to cross biological membranes (please also refer to IUCLID section 7.1). Therefore, in accordance with the criteria given in column 2 of Annex VIII to Regulation (EC) No 1907/2006 (REACH), the study on short-term toxicity to fish is considered scientifically not necessary and was waived.
Nevertheless, information available for the read across source substances titanium dioxide (CAS 13463-67-7) and diiron trioxide (CAS 1309-37-1) is summarized below.
Titanium dioxide
Data from two guideline studies and one non-guideline study with the source substance titanium dioxide (bulk form) is publicly available and is discussed in a Weight of Evidence approach..
One reliable guideline study (Klimisch 1, reliable without restriction) is publicly available for the read across substance titanium dioxide in its bulk form (reference 6.1.1 -1). A 96-hour Fish, Acute Toxicity Test according to OECD Guideline 203 was performed under static conditions and in compliance with the GLP principles. Because of the very low water solubility of the test substance the test solutions were prepared by using Water Accommodated Fractions in accordance with OECD Guideline 23 (2000). Ten fish (Oryzias latipes) were exposed to a limit loading rate of 100 mg test substance/L (1 replicate). In addition, a negative control (10 fish in 1 replicate) and a positive control with the reference substance Pentachlorophenol sodium salt were performed. The results of the test are expressed as loading rates: the 48- and 96-hour LL50 was determined to be >= 100 mg/L. The 48- and 96-hour NOELR was found to be 100 mg/L.
In an acute in vivo toxicity test with Fundulus heteroclitus (wild caught) the 96-hour TL50 (median tolerance limit) of the test item at low (5.0 ppt ) and high (25.3 ppt) salinity levels was determined to be >1000 mg/L (reference 6.1.1 -2).The reliability of the study was classified to be not assignable (Klimisch 4) because its documentation is not sufficient for assessment.
In a static Fish, Acute Toxicity Test according to OECD Guideline 203 with Oncorhynchus mykiss the 96 hour LC50 for the test item was determined to be higher than 100 mg/L (reference 6.1.1 -3). The reliability of the study was classified to be not assignable (Klimisch 4) because its documentation is not sufficient for assessment.
Key information on short-term toxicity to fish 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 for titanium dioxide (last accessed on: 18 March 2020) dispersions of microsized titanium dioxide are not acutely toxic to fish as the LC50 determined in experimental studies was found to be at least higher than 1000 mg/L and up to > 10,000 mg/L in fresh- and saltwater, respectively. Taking into account that microsized titanium dioxide is sparingly soluble in water, the substance is considered to be not acutely toxic to fish up to its solubility limit.
Diiron trioxide
Referring to the public ECHA REACH dossier for diiron trioxide (last accessed on: 18 March 2020) no short-term toxicity to fish was observed up to a concentration of 50000 mg/l (96-h LC0 ≥ 50000 mg/l).
Conclusion
The study does not need to be conducted as the substance is highly insoluble in water and unlikely to cross biological membranes, hence indicating that aquatic toxicity is unlikely to occur. This conclusion is supported by assessments for the structural analogues diiron trioxide (CAS 1309-37-1) and titanium dioxide (CAS 13463-67-7) demonstrating that short-term toxicity to fish is not to be expected. Both source substances are neither classified for short-term (acute) nor for long-term (chronic) aquatic toxicity according to Regulation (EC) No 1272/2008 (CLP).
Target and source substances 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 physico-chemical properties. Therefore, diiron titanium pentaoxide is also not considered acutely toxic to fish. Additional data on short-term toxicity of diiron titanium pentaoxide to fish are thus scientifically not necessary. Following a weight of evidence approach and based on the most reliable information for the source substance TiO2 (reference 6 .1.1-1) the 96-hour LC50 for diiron titanium pentaoxide is determined to be >= 100 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.
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.