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EC number: 237-057-8 | CAS number: 13597-65-4
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 the 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:
- Dizinc orthosilicate
- EC Number:
- 237-057-8
- EC Name:
- Dizinc orthosilicate
- Cas Number:
- 13597-65-4
- Molecular formula:
- H4O4Si.2Zn
- IUPAC Name:
- dizinc orthosilicate
- 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
Zinc silicate is slightly soluble in artificial sweat solution (2.45% of zinc released after 168 hours). The test item was highly soluble in artificial gastric fluid (92.2% of zinc released after 24 hours) and artificial lysosomal fluid (maximum release: 94.0% after 2 hours; 72.3% after 72 hours).
Zinc silicate was essentially insoluble in artificial interstitial fluid and PBS solution. After 24 hours, only 0.34 % of zinc was released in PBS and no release was observed at sampling points after 2, 24, 72 and 168 hours of incubation in the artificial interstitial fluid. The decrease of Zinc in artificial lysosomal fluid during the test (94.0% after 2 hours; 72.3% after 72 hours) is most likely due to the formation of zinc oxides, reducing the metal ions available for detection.
The % of dissolution was calculated considering an initial zinc silicate load of 100 mg and a maximum possible Zinc release of 59723 µg/L (calculated from the test item composition).
TABLE 1a Zinc Silicate:64Zn concentrations and % of dissolution in Artificial gastric fluid (pH 1.5)
Artificial gastric fluid (pH 1.5) |
64Zn (µg/L) |
Zinc Silicate (% of dissolution) |
|
T0 (*) |
Mean |
< 1.00 |
- |
S.D. |
- |
||
RSD% |
- |
||
T2h (**) |
Mean |
54605 |
91.4 |
S.D. |
2528 |
||
RSD% |
4.63 |
||
T8h (**) |
Mean |
54905 |
91.9 |
S.D. |
2862 |
||
RSD% |
5.21 |
||
T24h (**) |
Mean |
55039 |
92.2 |
S.D. |
4231 |
||
RSD % |
7.69 | ||
< 1.00: lower than the Limit of Quantification (L.O.Q. = 1.00 µg/L for Zn) but higher than the Limit of Detection (L.O.D. = 0.50 µg/L for Zn)
(*) This valueis 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 Zinc Silicate:64Zn concentrations and % of dissolution in Artificial lysosomal fluid (pH 4.5)
Artificial lysosomal fluid (pH 4.5) |
64Zn (µg/L) |
Zinc Silicate (% of dissolution) |
|
T0 (*) |
Mean |
< 1.00 |
- |
S.D. |
- |
||
RSD% |
- |
||
T2h(**) |
Mean |
56146 |
94.0 |
S.D. |
1655 |
||
RSD% |
2.95 |
||
T24h (**) |
Mean |
49170 |
82.3 |
S.D. |
2462 |
||
RSD% |
5.01 |
||
T72h (**) |
Mean |
43168 |
72.3 |
S.D. |
4662 |
||
RSD% |
10.80 |
||
< 1.00: lower than the Limit of Quantification (L.O.Q. = 1.00 µg/L for Zn) but higher than the Limit of Detection (L.O.D. = 0.50 µg/L for Zn)
(*) 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 Zinc Silicate:64Zn concentrations and % of dissolution in Artificial sweat solution (pH 6.5)
Artificial sweat solution (pH 6.5) |
64Zn (µg/L) |
Zinc Silicate (% of dissolution) |
|
T0 (*) |
Mean |
n.d. |
- |
S.D. |
- |
||
RSD% |
- |
||
T2h(**) |
Mean |
722 |
1.21 |
S.D. |
33 |
||
RSD% |
4.59 |
||
T24h (**) |
Mean |
1272 |
2.13 |
S.D. |
91 |
||
RSD% |
7.15 |
||
T72h (**) |
Mean |
1416 |
2.37 |
S.D. |
72 |
||
RSD% |
5.11 |
||
T168h (**) |
Mean |
1466 |
2.45 |
S.D. |
82 |
||
RSD% |
5.58 |
||
n.d.: lower than the Limit of Detection (L.O.D. = 0.50 µg/L for Zn).
(*) 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 Zinc Silicate:64Zn concentrations and % of dissolution in Phosphate buffered saline (PBS) (pH 7.2)
Phosphate buffered saline (PBS) (pH 7.2) |
64Zn (µg/L) |
Zinc Silicate (% of dissolution) |
|
T0 (*) |
Mean |
n.d. |
- |
S.D. |
- |
||
RSD% |
- |
||
T2h (**) |
Mean |
201 |
0.34 |
S.D. |
11 |
||
RSD% |
5.59 |
||
T24h (**) |
Mean |
205 |
0.34 |
S.D. |
12 |
||
RSD% |
6.05 |
||
n.d.: lower than the Limit of Detection (L.O.D. = 0.50 µg/L for Zn).
(*) 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 Zinc Silicate:64Zn concentrations and % of dissolution in Artificial interstitial fluid (pH 7.4)
Artificial interstitial fluid (pH 7.4) |
64Zn (µg/L) |
Zinc 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. = 0.50 µg/L for Zn).
(*) 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:
- Zinc silicate is highly soluble in artificial gastric fluid (pH 1.5) and artificial lysosomal fluid (pH 4.5). In artificial gastric fluid 92.2% of zinc was released after 24 hours and in artificial lysosomal fluid maximum release of 94.0% was observed after 2 hours and 72.3% of zinc was released after 72 hours. The decrease of zinc release in artificial lysosomal fluid during the test is most likely due to the formation of zinc oxides, reducing the metal ions available for detection.
Zinc silicate is slightly soluble in artificial sweat solution at pH 6.5 where a maximum of 2.45% zinc released was observed after 168 hours.
Zinc silicate was essentially insoluble in test media at pH ≥ 7.2 (artificial interstitial fluid, pH 7.2 and PBS solution, pH 7.5). After 24 hours, only 0.34 % of zinc was released in PBS and no release was observed at sampling points after 2, 24, 72 and 168 hours of incubation in the artificial interstitial fluid. - Executive summary:
A study was conducted to determine the dissolution and bioaccessibility of test item dizinc orthosilicate 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 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 zinc in five artificial physiological test 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)) at specific time intervals using ICP-MS analysis.
Zinc silicate is highly soluble in artificial gastric fluid (pH 1.5) and artificial lysosomal fluid (pH 4.5). In artificial gastric fluid 92.2% of zinc was released after 24 hours and in artificial lysosomal fluid a maximum release of 94.0% was observed after 2 hours and 72.3% of zinc was released after 72 hours. The decrease of zinc release in artificial lysosomal fluid during the test is most likely due to the formation of zinc oxides, reducing the metal ions available for detection. Zinc silicate is slightly soluble in artificial sweat solution at pH 6.5 where a maximum of 2.45% zinc released was observed after 168 hours. Zinc silicate was essentially insoluble in test media at pH ≥7.2 (artificial interstitial fluid, pH 7.2 and PBS solution, pH 7.5). After 24 hours, only 0.34 % of zinc was released in PBS and no release was observed at sampling points after 2, 24, 72 and 168 hours of incubation in the artificial interstitial fluid.
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