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EC number: 942-982-1 | CAS number: -
- 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
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
- Type of study / information:
- A study was conducted to determine the dissolution and bioaccessibility of test item in five artificial physiological test media (phosphate-buffered saline (PBS) (pH 7.2), artificial interstitial fluid (pH 7.4), artificial sweat solution (pH 6.5), artificial lysosomal fluid (pH 4.5) and artificial gastric fluid (pH 1.5)).
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Stopford W, Turner J, Cappelini D, Brock T 2003. Bioaccessibility testing of Cobalt compounds. Journal of Environmental Monitoring 5:675-680.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EEC guideline SANCO/3029/99 rev. 4 dated 11/07/00: Working document “Guidance for generating and reporting methods of analysis in support of residue data requirements for Annex II (part A, Section 4) and Annex III (part A, Section 5)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- antimony trioxide
- IUPAC Name:
- antimony trioxide
- Reference substance name:
- Titanium dioxide
- EC Number:
- 236-675-5
- EC Name:
- Titanium dioxide
- Cas Number:
- 13463-67-7
- Molecular formula:
- O2Ti
- IUPAC Name:
- Titanium(IV) oxide
- Reference substance name:
- Calcium oxide
- EC Number:
- 215-138-9
- EC Name:
- Calcium oxide
- Cas Number:
- 1305-78-8
- Molecular formula:
- CaO
- IUPAC Name:
- oxocalcium
- Reference substance name:
- Silicon dioxide
- EC Number:
- 231-545-4
- EC Name:
- Silicon dioxide
- Cas Number:
- 7631-86-9
- Molecular formula:
- O2Si
- IUPAC Name:
- dioxosilane
- Test material form:
- solid: particulate/powder
Constituent 1
Constituent 2
Constituent 3
Constituent 4
- Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature without particular precaution to avoid the light exposure
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: None
Results and discussion
Any other information on results incl. tables
Titanium dioxide is essentially insoluble in artificial interstitial fluid, in artificial sweat solution and in PBS solution, and slightly soluble in artificial gastric fluid (0.41%) and in artificial lysosomal fluid (0.26%).
Antimony oxide is slightly soluble in all artificial physiological test media (minimum release in artificial interstitial fluid and in PBS solution: 0.12%; maximum release in artificial gastric fluid: 0.33%).
The % of dissolution for titanium dioxide and for antimony oxide was calculated from the test item composition considering an initial Uverithe load of 100 mg. The maximum possible release for Titanium is 23350 µg/L, while for Antimony is 32245 µg/L.
TABLE 1a Uverithe:47Ti and123Sb concentrations and % of dissolution in Artificial gastric fluid (pH 1.5)
Artificial gastric fluid (pH 1.5) |
47Ti (µg/L) |
Titanium dioxide (% of dissolution) |
123Sb (µg/L) |
Antimony oxide (% of dissolution) |
|
T0 (*) |
Mean |
n.d. |
- |
n.d. |
- |
S.D. |
- |
- |
|||
RSD% |
- |
- |
|||
T2h (**) |
Mean |
54.35 |
0.23 |
59.88 |
0.19 |
S.D. |
3.31 |
6.91 |
|||
RSD% |
6.08 |
11.55 |
|||
T8h (**) |
Mean |
79.54 |
0.34 |
82.60 |
0.26 |
S.D. |
1.73 |
5.51 |
|||
RSD% |
2.17 |
6.67 |
|||
T24h (**) |
Mean |
94.79 |
0.41 |
107.27 |
0.33 |
S.D. |
5.96 |
8.83 |
|||
RSD% |
6.29 |
8.23 |
n.d.: lower than the Limit of Detection (L.O.D. = 0.50 µg/L for Ti and Sb).
(*) This valueis considered the contribution of the test medium.
(**) This valuewas calculated subtracting the relevant Control sample value, in order to consider the contribution of the test medium.
The between-vessel variation was less than 20 % in accordance with OECD Series No. 29 (ENV/JM/MONO(2001)9).
TABLE 1b Uverithe:47Ti and123Sb concentrations and % of dissolution in Artificial lysosomal fluid (pH 4.5)
Artificial lysosomal fluid (pH 4.5) |
47Ti (µg/L) |
Titanium dioxide (% of dissolution) |
123Sb (µg/L) |
Antimony oxide (% of dissolution) |
|
T0 (*) |
Mean |
3.28 |
- |
n.d. |
- |
S.D. |
0.08 |
- |
|||
RSD% |
2.37 |
- |
|||
T2h(**) |
Mean |
19.99 |
0.09 |
48.34 |
0.15 |
S.D. |
1.01 |
3.99 |
|||
RSD% |
5.04 |
8.25 |
|||
T24h (**) |
Mean |
55.04 |
0.24 |
81.64 |
0.25 |
S.D. |
1.21 |
0.46 |
|||
RSD% |
2.20 |
0.57 |
|||
T72h (**) |
Mean |
60.01 |
0.26 |
84.79 |
0.26 |
S.D. |
1.38 |
0.95 |
|||
RSD% |
2.30 |
1.12 |
n.d.: lower than the Limit of Detection (L.O.D. = 0.50 µg/L for Sb).
(*) This valueis considered the contribution of the test medium.
(**) This valuewas calculated subtracting the relevant Control sample value, in order to consider the contribution of the test medium.
The between-vessel variation was less than 20 % in accordance with OECD Series No. 29 (ENV/JM/MONO(2001)9).
TABLE 1c Uverithe:47Ti and123Sb concentrations and % of dissolution in Artificial sweat solution (pH 6.5)
Artificial sweat solution (pH 6.5) |
47Ti (µg/L) |
Titanium dioxide (% of dissolution) |
123Sb (µg/L) |
Antimony oxide (% of dissolution) |
|
T0 (*) |
Mean |
n.d. |
- |
n.d. |
- |
S.D. |
- |
- |
|||
RSD% |
- |
- |
|||
T2h(**) |
Mean |
n.d. |
0.00 |
18.58 |
0.06 |
S.D. |
- |
0.43 |
|||
RSD% |
- |
2.30 |
|||
T24h (**) |
Mean |
1.01 |
0.00 |
37.50 |
0.12 |
S.D. |
0.01 |
1.02 |
|||
RSD% |
1.02 |
2.73 |
|||
T72h (**) |
Mean |
1.62 |
0.01 |
47.56 |
0.15 |
S.D. |
0.20 |
2.86 |
|||
RSD% |
12.07 |
6.01 |
|||
T168h (**) |
Mean |
2.79 |
0.01 |
48.40 |
0.15 |
S.D. |
0.12 |
1.80 |
|||
RSD% |
4.39 |
3.71 |
n.d.: lower than the Limit of Detection (L.O.D. = 0.50 µg/L for Ti and Sb).
(*) This valueis considered the contribution of the test medium.
(**) This valuewas calculated subtracting the relevant Control sample value, in order to consider the contribution of the test medium.
The between-vessel variation was less than 20 % in accordance with OECD Series No. 29 (ENV/JM/MONO(2001)9).
TABLE 1d Uverithe:47Ti and123Sb concentrations and % of dissolution in Phosphate buffered saline (PBS) (pH 7.2)
Phosphate buffered saline (PBS) (pH 7.2) |
47Ti (µg/L) |
Titanium dioxide (% of dissolution) |
123Sb (µg/L) |
Antimony oxide (% of dissolution) |
|
T0 (*) |
Mean |
5.97 |
- |
< 1.00 |
- |
S.D. |
0.26 |
- |
|||
RSD% |
4.41 |
- |
|||
T2h (**) |
Mean |
1.76 |
0.01 |
19.97 |
0.06 |
S.D. |
0.12 |
0.23 |
|||
RSD% |
6.84 |
1.18 |
|||
T24h (**) |
Mean |
2.48 |
0.01 |
38.14 |
0.12 |
S.D. |
0.19 |
1.48 |
|||
RSD% |
7.83 |
3.87 |
<1.00 : lower than the Limit of Quantification (L.O.Q. = 1.00 µg/L for Sb) but higher than the Limit of Detection (L.O.D. = 0.50 µg/L for Sb)
(*) This valueis considered the contribution of the test medium.
(**) This valuewas calculated subtracting the relevant Control sample value, in order to consider the contribution of the test medium.
The between-vessel variation was less than 20 % in accordance with OECD Series No. 29 (ENV/JM/MONO(2001)9).
TABLE 1e Uverithe:47Ti and123Sb concentrations and % of dissolution Artificial interstitial fluid (pH 7.4)
Artificial interstitial fluid (pH 7.4) |
47Ti (µg/L) |
Titanium dioxide (% of dissolution) |
123Sb (µg/L) |
Antimony oxide (% of dissolution) |
|
T0 (*) |
Mean |
1.50 |
- |
n.d. |
- |
S.D. |
0.04 |
- |
|||
RSD% |
2.70 |
- |
|||
T2h(**) |
Mean |
1.69 |
0.01 |
11.82 |
0.04 |
S.D. |
0.19 |
0.61 |
|||
RSD% |
11.53 |
5.20 |
|||
T24h (**) |
Mean |
2.21 |
0.01 |
29.98 |
0.09 |
S.D. |
0.17 |
2.18 |
|||
RSD% |
7.88 |
7.27 |
|||
T72h (**) |
Mean |
2.21 |
0.01 |
36.97 |
0.11 |
S.D. |
0.17 |
3.54 |
|||
RSD% |
7.80 |
9.57 |
|||
T168h (**) |
Mean |
2.74 |
0.01 |
37.40 |
0.12 |
S.D. |
0.26 |
2.97 |
|||
RSD% |
9.34 |
7.94 |
n.d.: lower than the Limit of Detection (L.O.D. = 0.50 µg/L for Sb).
(*) This valueis considered the contribution of the test medium.
(**) This valuewas calculated subtracting the relevant Control sample value, in order to consider the contribution of the test medium.
The between-vessel variation was less than 20 % in accordance with OECD Series No. 29 (ENV/JM/MONO(2001)9).
Applicant's summary and conclusion
- Conclusions:
- Titanium dioxide is essentially insoluble in artificial interstitial fluid, in artificial sweat solution and in PBS solution, and it is slightly soluble in artificial gastric fluid (0.41% released after 24 hours) and in artificial lysosomal fluid (0.26% released after 72 hours). The solubility of antimony oxide is very low in all artificial physiological test media. The lowest release of 0.12% was observed in artificial interstitial fluid after 168 and in PBS solution after 24 hours and maximum release of 0.33% was observed in artificial gastric fluid after 24 hours.
- Executive summary:
A study was conducted to determine the dissolution and bioaccessibility of test item in five artificial physiological test media selected to simulate relevant human-chemical interactions (Martinez 2016).
The study was performed according the method described by Stopford et al. (2003) and SANCO/3029/99 guideline and is a GLP-compliant. This study is considered reliable without restrictions (Klimisch 1) and is suitable for use as a key study for this endpoint.
The dissolved amount of the test item was quantified by the mass concentration of titanium dioxide and antimony oxide in five artificial physiological test media (phosphate-buffered saline (PBS) (pH 7.2),artificial interstitial fluidor Gamble’s solution (pH 7.4), artificial sweat solution (pH 6.5), artificial lysosomal fluid (pH 4.5) and artificial gastric fluid (pH 1.5)) at specific time intervals using ICP-MS analysis.
The results indicate that whilst titanium dioxide is essentially insoluble in artificial interstitial fluid, in artificial sweat solution and in PBS solution, it is slightly soluble in artificial gastric fluid (0.41% released after 24 hours) and in artificial lysosomal fluid (0.26% released after 72 hours).
The solubility of antimony oxide is very low in all artificial physiological test media. The highest release of antimony oxide of 0.33% was observed in artificial gastric fluid after 24 hours.
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