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EC number: 810-509-7 | CAS number: 14708-87-3
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 June 2016 to 06 July 2016
- 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:
- dissolution and bioaccessibility of test item bismuth silicate
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:
- not applicable
- Qualifier:
- according to guideline
- Guideline:
- other: “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)
- Version / remarks:
- EEC guideline SANCO/3029/99 rev. 4 dated 11/07/00
- Deviations:
- not applicable
- Principles of method if other than guideline:
- The dissolution and bioaccessibility of test item bismuth silicate was conducted in five physiological media: phosphate-buffered saline (PBS) (pH 7.2), artificial interstitial fluid or 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), selected to simulate relevant human-chemical interactions. The dissolved amount of the test item was quantified by the mass concentration of bismuth.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- tetrabismuth(3+) trisilicate
- EC Number:
- 810-509-7
- Cas Number:
- 14708-87-3
- Molecular formula:
- Bi4O12Si3
- IUPAC Name:
- tetrabismuth(3+) trisilicate
- Test material form:
- solid
Constituent 1
Results and discussion
Any other information on results incl. tables
Based on the release of bismuth in five artificial physiological test media, bismuth silicate is considered essentially insoluble in artificial interstitial fluid, sweat solution and PBS, and slightly soluble in gastric fluid (1.00 % bismuth released after 24 hours). Bismuth silicate is more soluble in artificial lysosomal fluid (51.71% of bismuth was released after 72 hours).
The analytical results of the dissolution and bioaccessibility of test item bismuth silicate are summarized in the following Tables from 1a to 1e.
The % of dissolution was calculated considering an initial bismuth silicate load of 100 mg and a maximum possible bismuth release of 74769 µg/L (calculated from the test item composition).
TABLE 1a Bismuth Silicate:209Bi concentrations and % of dissolution in Artificial gastric fluid (pH 1.5)
Artificial gastric fluid (pH 1.5) |
209Bi (µg/L) |
Bismuth Silicate (% of dissolution) |
|
T0 (*) |
Mean |
n.d. |
- |
S.D. |
- |
||
RSD% |
- |
||
T2h (**) |
Mean |
738 |
0.99 |
S.D. |
29.42 |
||
RSD% |
3.99 |
||
T8h (**) |
Mean |
744 |
1.00 |
S.D. |
22.71 |
||
RSD% |
3.05 |
||
T24h (**) |
Mean |
749 |
1.00 |
S.D. |
20.71 |
||
RSD% |
2.77 |
||
n.d.: lower than the Limit of Detection (L.O.D. = 0.50µg/L for Bi).
(*) This value is considered the contribution of the test medium.
(**) This value was 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).[SK1]
TABLE 1b Bismuth Silicate:209Bi concentrations and % of dissolution in Phosphate buffered saline (PBS) (pH 7.2)
Phosphate buffered saline (PBS) (pH 7.2) |
209Bi (µg/L) |
Bismuth Silicate (% of dissolution) |
|
T0 (*) |
Mean |
n.d. |
- |
S.D. |
- |
||
RSD% |
- |
||
T2h (**) |
Mean |
2.06 |
0.003 |
S.D. |
0.09 |
||
RSD% |
4.35 |
||
T24h (**) |
Mean |
2.79 |
0.004 |
S.D. |
0.05 |
||
RSD% |
1.75 |
||
n.d.: lower than the Limit of Detection (L.O.D. = 0.50µg/L for Bi).
(*) This value is considered the contribution of the test medium.
(**) This value was 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 Bismuth Silicate:209Bi concentrations and % of dissolution in Artificial lysosomal fluid (pH 4.5
Artificial lysosomal fluid (pH 4.5) |
209Bi (µg/L) |
Bismuth Silicate (% of dissolution) |
|
T0 (*) |
Mean |
n.d. |
- |
S.D. |
- |
||
RSD% |
- |
||
T2h(**) |
Mean |
7371 |
9.86 |
S.D. |
608.67 |
||
RSD% |
8.26 |
||
T24h (**) |
Mean |
35606 |
47.62 |
S.D. |
1230.32 |
||
RSD% |
3.46 |
||
T72h (**) |
Mean |
38663 |
51.71 |
S.D. |
1450.85 |
||
RSD% |
3.75 |
||
n.d.: lower than the Limit of Detection (L.O.D. = 0.50µg/L for Bi).
(*) This value is considered the contribution of the test medium.
(**) This value was 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 Bismuth Silicate:209Bi concentrations and % of dissolution in Artificial sweat solution pH 6.5
Artificial sweat solution (pH 6.5) |
209Bi (µg/L) |
Bismuth Silicate (% of dissolution) |
|
T0 (*) |
Mean |
n.d. |
- |
S.D. |
- |
||
RSD% |
- |
||
T2h(**) |
Mean |
4.02 |
0.01 |
S.D. |
0.30 |
||
RSD% |
7.41 |
||
T24h (**) |
Mean |
4.14 |
0.01 |
S.D. |
0.38 |
||
RSD% |
9.11 |
||
T72h (**) |
Mean |
6.35 |
0.01 |
S.D. |
0.30 |
||
RSD% |
4.68 |
||
T168h (**) |
Mean |
6.39 |
0.01 |
S.D. |
0.16 |
||
RSD% |
2.58 |
||
n.d.: lower than the Limit of Detection (L.O.D. = 0.50µg/L for Bi).
(*) This value is considered the contribution of the test medium.
(**) This value was 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 Bismuth Silicate:209Bi concentrations and % of dissolution in Artificial interstitial fluid (pH 7.4)
Artificial interstitial fluid (pH 7.4) |
209Bi (µg/L) |
Bismuth Silicate (% of dissolution) |
|
T0 (*) |
Mean |
n.d. |
- |
S.D. |
- |
||
RSD% |
- |
||
T2h(**) |
Mean |
n.d. |
0.00 |
S.D. |
- |
||
RSD% |
- |
||
T24h (**) |
Mean |
n.d. |
0.00 |
S.D. |
- |
||
RSD% |
- |
||
T72h (**) |
Mean |
n.d. |
0.00 |
S.D. |
- |
||
RSD% |
- |
||
T168h (**) |
Mean |
n.d. |
0.00 |
S.D. |
- |
||
RSD% |
- |
||
n.d.: lower than the Limit of Detection (L.O.D. = 0.50µg/L for Bi).
(*) This value is considered the contribution of the test medium.
(**) This value was 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:
- Based on the release of bismuth in five artificial physiological test media, bismuth silicate is considered essentially insoluble in artificial interstitial fluid, sweat solution and PBS, and slightly soluble in gastric fluid (1.00 % bismuth released after 24 hours). Bismuth silicate is soluble in artificial lysosomal fluid (51.71% of bismuth was released after 72 hours).
- Executive summary:
The dissolution and bioaccessibility of test item bismuth silicate was conducted in five physiological media: phosphate-buffered saline (PBS) (pH 7.2), artificial interstitial fluid or 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)), selected to simulate relevant human-chemical interactions. The dissolved amount of the test item was quantified by the mass concentration of bismuth using ICP-MS.
Based on the release of bismuth in five artificial physiological test media, bismuth silicate is considered essentially insoluble in artificial interstitial fluid, sweat solution and PBS. It is slightly soluble in gastric fluid and soluble in artificial lysosomal fluid. In gastric fluid 1.00 % bismuth was released after 24 hours and 51.71% of bismuth was released after incubation for 72 hours in lysosomal fluid.
The study was conducted according to the standard methods and is GLP-compliant and therefore is considered reliable without restrictions.
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