Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

additional toxicological information
Type of information:
experimental study
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test procedure in accordance with national standard methods with acceptable restrictions.

Data source

Reference Type:
study report
Report date:

Materials and methods

Type of study / information:
The bioavailability of silicic acid aluminium magnesium sodium salt was investigated in an artifical test system of the digestive tract.
Test guideline
equivalent or similar to guideline
other: DIN 19738: Resorptionsverfügbarkeit von organischen und anorganischen Schadstoffen aus kontaminiertem Bodenmaterial", July 2004
- determination of Mg via titration; lower temperature for the 2nd test
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Silicic acid, aluminum magnesium sodium salt
EC Number:
EC Name:
Silicic acid, aluminum magnesium sodium salt
Cas Number:
Molecular formula:
aluminium(3+) magnesium(2+) sodium tris(oxosilanebis(olate))
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
- Name of test material (as cited in study report): Durafill 200 (Sodium magnesium aluminium silicate)
- Analytical purity: SiO2: 81%; Al2O3: 8.5 %; MgO: 2%
- Other: All samples were processed in April 2009.

Results and discussion

Any other information on results incl. tables

Concentration in samples

 Sample  1 mean   SD  RSD
 concentration of Mg in mg/L  69.7 62.3  66.0  5.2  7.9% 
 concentration of Al in mg/L  < 0.2 < 0.2  < 0.2  - -

Concentration in blanks

 Sample  blank 1 blank 2 
 concentration of Mg in mg/L  17.4 9.4 
 concentration of Al in mg/L  < 0.2 < 0.2 

Differences, samples - blank1

Sample  1 mean   SD  RSD
 concentration of Mg in mg/L 52.3 44.9  48.6 5.2  10.8% 
 concentration of Al in mg/L  < 0.2 < 0.2  < 0.2  - -

Mobilised masses and bioavailability of Mg

Sample  1 mean   SD  RSD
Mobilised masses of test item µg/g 5230.0 4490.0 
4860.0 523.3 10.8% 
Bioavailability % 42.87% 36.8%  39.84% 4.29% 10.8%

The mobilised masses of aluminium were 0%, because no Al was detecatable in all solutions.

The bioavailability of Mg was 39.8 %, with a relative standard deviation of 10.8%. It should be kept in mind that the different components of the test item have different solubilities in aqueous solutions. Sodium is probably dissolved completely, whereas aluminium could not be detected in the solutions. Therefore, bioavailability must in this case always be reported in reference to the analysed ion.

Applicant's summary and conclusion

Due to the low water solubility of test item only part of the substance can be solved in aqueous solutions, Al ions are even not detectable.
Only Mg ions could be used for determination of bioavailbility: 39.84%