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EC number: 309-892-9 | CAS number: 101356-96-1
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 Strontium apatite, copper doped 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:
- Barium oxide (BaO), solid soln. with calcium oxide, magnesium oxide, phosphorus oxide (P2O5), strontium oxide and zinc oxide, copper-doped
- EC Number:
- 309-892-9
- EC Name:
- Barium oxide (BaO), solid soln. with calcium oxide, magnesium oxide, phosphorus oxide (P2O5), strontium oxide and zinc oxide, copper-doped
- Cas Number:
- 101356-96-1
- Molecular formula:
- Not applicable
- IUPAC Name:
- Barium oxide (BaO), solid soln. with calcium oxide, magnesium oxide, phosphorus oxide (P2O5), strontium oxide and zinc oxide, copper-doped
- Test material form:
- solid
Constituent 1
- 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
The results indicate that whilst copper oxide is essentially insoluble in artificial interstitial fluid, phosphate buffered solution (PBS) and artificial sweat solution, the compound is highly soluble in artificial gastric fluid (maximum release: 83.4% after 8 hours; 83.2% after 24 hours) and in artificial lysosomal fluid (maximum release: 86.7% after 2 hours; 78.6% after 72 hours). The solubility of strontium oxide is negligible in artificial interstitial fluid (1.82 %), PBS solution (9.44 %) and artificial sweat solution (11.45 %), but highly soluble in artificial lysosomal fluid (90.0 %) and completely soluble in artificial gastric fluid (100.2 %).
The analytical results of the dissolution and bioaccessibility of test item Strontium apatite, copper doped are summarized in the Tables from 1a to 1e.
The % of dissolution for Copper oxide and for Strontium oxide was calculated considering an initial Strontium apatite, copper doped load of 100 mg/L. The maximum possible release for Copper is 2780 µg/L, while for Strontium is 58526 µg/L (calculated from the test item composition).
TABLE 1a Strontium apatite, copper doped:63Cu and88Sr concentrations and % of dissolution in Artificial gastric fluid (pH 1.5)
Artificial gastric fluid (pH 1.5) |
63Cu (µg/L) |
Copper oxide (% of dissolution) |
88Sr (µg/L) |
Strontium oxide (% of dissolution) |
|
T0 (*) |
Mean |
n.d. |
- |
n.d. |
- |
S.D. |
- |
- |
|||
RSD% |
- |
- |
|||
T2h (**) |
Mean |
2287 |
82.3 |
58540 |
100.0 |
S.D. |
74 |
2209 |
|||
RSD% |
3.25 |
3.77% |
|||
T8h (**) |
Mean |
2319 |
83.4 |
58642 |
100.2 |
S.D. |
86 |
1615 |
|||
RSD% |
3.72 |
2.75% |
|||
T24h (**) |
Mean |
2312 |
83.2 |
58663 |
100.2 |
S.D. |
90 |
1677 |
|||
RSD% |
3.91 |
2.86% |
|||
n.d.: lower than the Limit of Detection (L.O.D. = 0.50 µg/L for Cu and Sr).
(*) 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 1b Strontium apatite, copper doped:63Cu and88Sr concentrations and % of dissolution in Artificial lysosomal fluid (pH 4.5)
Artificial lysosomal fluid (pH 4.5) |
63Cu (µg/L) |
Copper oxide (% of dissolution) |
88Sr (µg/L) |
Strontium oxide (% of dissolution) |
|
T0 (*) |
Mean |
4.06 |
- |
12.68 |
- |
S.D. |
0.09 |
0.13 |
|||
RSD% |
2.14 |
1.0 |
|||
T2h(**) |
Mean |
2410 |
86.7 |
32359 |
55.3 |
S.D. |
92 |
1342 |
|||
RSD% |
3.81 |
4.15 |
|||
T24h (**) |
Mean |
2327 |
83.7 |
51925 |
88.7 |
S.D. |
117 |
600 |
|||
RSD% |
5.03 |
1.16 |
|||
T72h (**) |
Mean |
2186 |
78.6 |
52671 |
90.0 |
S.D. |
45 |
391 |
|||
RSD% |
2.05 |
0.74 |
|||
(*) 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 Strontium apatite, copper doped:63Cu and88Sr concentrations and % of dissolution in Artificial sweat solution (pH 6.5)
Artificial sweat solution (pH 6.5) |
63Cu (µg/L) |
Copper oxide (% of dissolution) |
88Sr (µg/L) |
Strontium oxide (% of dissolution) |
|
T0 (*) |
Mean |
n.d. |
- |
n.d. |
- |
S.D. |
- |
- |
|||
RSD% |
- |
- |
|||
T2h(**) |
Mean |
81.57 |
2.93 |
5702 |
9.74 |
S.D. |
1.83 |
405 |
|||
RSD% |
2.25 |
7.11 |
|||
T24h (**) |
Mean |
70.43 |
2.53 |
6410 |
10.95 |
S.D. |
3.19 |
623 |
|||
RSD% |
4.53 |
9.72 |
|||
T72h (**) |
Mean |
53.71 |
1.93 |
6653 |
11.37 |
S.D. |
1.61 |
564 |
|||
RSD% |
3.00 |
8.47 |
|||
T168h (**) |
Mean |
36.55 |
1.31 |
6703 |
11.45 |
S.D. |
3.51 |
91 |
|||
RSD% |
9.61 |
1.36 |
|||
n.d.: lower than the Limit of Detection (L.O.D. = 0.50 µg/L for Cu and Sr).
(*) 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 Strontium apatite, copper doped:63Cu and88Sr concentrations and % of dissolution in Phosphate buffered saline (PBS) (pH 7.2)
Phosphate buffered saline (PBS) (pH 7.2) |
63Cu (µg/L) |
Copper oxide (% of dissolution) |
88Sr (µg/L) |
Strontium oxide (% of dissolution) |
|
T0 (*) |
Mean |
< 1.00 |
- |
n.d. |
- |
S.D. |
- |
- |
|||
RSD% |
- |
- |
|||
T2h (**) |
Mean |
4.39 |
0.16 |
1923 |
3.29 |
S.D. |
0.21 |
187 |
|||
RSD% |
4.89 |
9.75 |
|||
T24h (**) |
Mean |
4.79 |
0.17 |
5525 |
9.44 |
S.D. |
0.16 |
379 |
|||
RSD% |
3.27 |
6.87 |
|||
n.d.: lower than the Limit of Detection (L.O.D. = 0.50 µg/L for Sr).
<1.00 : lower than theLimit of Quantification (L.O.Q. = 1.00 µg/L for Cu) but higher than the Limit of Detection (L.O.D. = 0.50 µg/L for Cu)
(*) 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 Strontium apatite, copper doped:63Cu and88Sr concentrations and % of dissolution Artificial interstitial fluid (pH 7.4)
Artificial interstitial fluid (pH 7.4) |
63Cu (µg/L) |
Copper oxide (% of dissolution) |
88Sr (µg/L) |
Strontium oxide (% of dissolution) |
|
T0 (*) |
Mean |
n.d. |
- |
9.58 |
- |
S.D. |
- |
0.66 |
|||
RSD% |
- |
6.84 |
|||
T2h(**) |
Mean |
14.39 |
0.52 |
986 |
1.68 |
S.D. |
0.93 |
37 |
|||
RSD% |
6.43 |
3.74 |
|||
T24h (**) |
Mean |
3.05 |
0.11 |
1020 |
1.74 |
S.D. |
0.15 |
12 |
|||
RSD% |
4.82 |
1.15 |
|||
T72h (**) |
Mean |
< 1.00 |
0.00 |
1054 |
1.80 |
S.D. |
- |
29 |
|||
RSD% |
- |
2.76 |
|||
T168h (**) |
Mean |
n.d. |
0.00 |
1066 |
1.82 |
S.D. |
- |
28 |
|||
RSD% |
- |
2.62 |
|||
n.d.: lower than the Limit of Detection (L.O.D. = 0.50 µg/L for Cu).
<1.00 : lower than theLimit of Quantification (L.O.Q. = 1.00 µg/L for Cu) but higher than the Limit of Detection (L.O.D. = 0.50 µg/L for Cu)
(*) 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:
- The results indicate that Strontium apatite, copper doped is highly soluble in test media at pH 1.5 (artificial gastric fluid) and 4.5 (artificial lysosomal fluid). In artificial gastric fluid, 83.4% and 83.2% of copper oxide was released after 8 hours and 24 hours, respectively and in artificial lysosomal fluid maximum release of 86.7% was observed after 2 hours and 78.6% of copper oxide was released after 72 hours. Strontium oxide is highly soluble in artificial lysosomal fluid (90.0 % of strontium oxide was released after 72 hours) and completely soluble in artificial gastric fluid (100.2 % of strontium oxide was released after 24 hours).
Strontium apatite, copper doped is less soluble in test media at pH 6.5 and above. Copper oxide is essentially insoluble in artificial interstitial fluid (maximum release of 0.52% observed after 2 hours, and no release observed after 168 hours), phosphate buffered solution (0.17 % of copper oxide released after 24 hours) and artificial sweat solution (maximum of 2.93 % of copper oxide released after 2 hours). Also, the solubility of strontium oxide is low in artificial interstitial fluid (1.82 % of strontium oxide released after 168 hours), PBS solution (9.44 % of strontium oxide released after 24 hours) and artificial sweat solution (11.45 % of strontium oxide released after 168 hours).
Both copper and strontium oxides are highly soluble in artificial gastric fluid and in artificial lysosomal fluid while have the lowest solubility in artificial interstitial fluid. - Executive summary:
A study was conducted to determine the dissolution and bioaccessibility of test item Strontium apatite, copper doped in five artificial physiological test media selected to simulate relevant human-chemical interactions (Pardo 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 copper and strontium 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.
Copper oxide is essentially insoluble in artificial interstitial fluid and PBS solution, and slightly soluble in artificial sweat solution (maximum release: 2.93% after 2 hours; 1.31% after 168 hours), while is highly soluble in artificial gastric fluid (maximum release: 83.4% after 8 hours; 83.2% after 24 hours) and in artificial lysosomal fluid (maximum release: 86.7% after 2 hours; 78.6% after 72 hours). Strontium oxide is slightly soluble in artificial interstitial fluid (1.82 %), quite soluble in PBS solution (9.44 %) and in artificial sweat solution (11.45 %), highly soluble in artificial lysosomal fluid (90.0 %) and completely soluble in artificial gastric fluid (100.2 %).
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