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Additional toxicological data

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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:
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. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

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

 

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

Ci                                           = measured element concentration in µg/L

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

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

 

Calculation of Bioaccessibility

Bioaccessibility was calculated from

 

Ri = (wi,mob * 100%)/wi,fest   with

 

Ri                                           = bioaccessible part in %

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

wi,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