Calcium, carbonate hydroxy aluminum complexes

Additional toxicological data

Administrative data

Endpoint:

additional toxicological information

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-01-22

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Type of study / information:

Determination of the resorption in the digestive tract of CAHC according to DIN 19738 to determine the bioavailable parts.

Test guideline

Qualifier:

according to guideline

Guideline:

other: DIN 19738

Deviations:

yes

Remarks:

Temperature in some conducts was outside the range of 37 ± 1 °C. As virtually no dissolution of the test item was observed, the deviation was assessed as uncritical; The samples were stored in closed vessels at 2 - 8°C; this is uncritical because met-als

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Calcium, carbonate hydroxy aluminum complexes

EC Number:

307-546-1

EC Name:

Calcium, carbonate hydroxy aluminum complexes

Cas Number:

97660-35-0

Molecular formula:

Ca4Al2(OH)12CO3*5H20

IUPAC Name:

dialuminium(3+) tetracalcium dodecahydroxide carbonate

Results and discussion

Any other information on results incl. tables

Composition of Test Item

This was calculated from the data of X-ray analysis as presented in the following table:

Table9.1‑a      Composition of Test Item

Parameter	Mr in g/mol	% in Oxide	% in Test Item	µg/g Test Item
Al2O3	101.9613	-	20.00%	-
Al	26.9815	52.92%	10.58%	105849.9646
CaO	56.08		41.00%	-
Ca	40.08	71.74%	29.30%	293024.2511

 

Calculation of Mobilised Mass

The mobilised masses of the elements were calculated from

 

  wi,mob = (ci * V)/mE             with

 

w_i,mob                                     = mobilised part in µg/g test item per element

C_i                                           = measured element concentration in µg/L

V                                            = total volume in L of the aqueous phase (standard is 200 ml)

m_E                                         = weight of used test item (standard is 2.0 g)

 

Calculation of Bioaccessibility

Bioaccessibility was calculated from

 

Ri = (wi,mob * 100%)/wi,fest   with

 

R_i                                           = bioaccessible part in %

w_i,mob                                     = mobilised part in µg/g test item per element

w_i,fest                                      = part of the element in the test item in µg/g

Finding and Results

Two tests with and two tests without the addition of full milk powder were performed, as well as two blanks with and without milk powder.

An aliquot of the resulting solutions was thermically digested and resoluted in conc. HCl and water. The resulting solutions were measured via AAS for Al and Ca.

Al determinations were above LOQ.

The mobilised masses of the measured elements and the bioaccessibilities are given in tabular form.

 

Samples without addition of milk powder:

Measured Ingredient	Parameter	Mean	Standard Deviation	Relative Standard Deviation (%)
Al	Mobilised mass of test item in µg/g	28.7803	23.8295	82.7980%
	Bioavailability in %	0.0272%	0.0002	82.7980%
Ca	Mobilised mass of test item in µg/g	12327.8775	2376.2201	19.2752%
	Bioavailability in %	4.2071%	0.0081	19.2752%

 

Samples with addition of milk powder:

Measured Ingredient	Parameter	Mean	Standard Deviation	Relative Standard Deviation (%)
Al	Mobilised mass of test item in µg/g	9939.2498	7430.6891	74.7611%
	Bioavailability in %	9.3900%	0.0702	74.7611%
Ca	Mobilised mass of test item in µg/g	7912.6201	10885.2337	137.5680%
	Bioavailability in %	2.70%	0.03715	137.5680%

 

Applicant's summary and conclusion

Conclusions:

The Al components of the test item are very poorly soluble in the digestive tract. All values of the samples were above the values of the blanks and above LOQ, though.The Ca components of the test item are slightly soluble in the digestive tract. bioaccessibility was doubtlessl low and neither Ca nor Al are harmful in the concentrations which were found in the samples

Executive summary:

The Al components of the test item are very poorly soluble in the digestive tract. All values of the samples were above the values of the blanks and above LOQ, though.The Ca components of the test item are slightly soluble in the digestive tract. bioaccessibility was doubtlessl low and neither Ca nor Al are harmful in the concentrations which were found in the samples