Dodecaaluminium calcium nonadecaoxide

Additional toxicological data

Administrative data

Endpoint:

additional toxicological information

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009-04-21 - 2009-12-09

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Type of study / information:

This study was performed in order to determine the resorption in the lung of Dodeca¬aluminium calcium nonadecaoxide, Al12O19Ca (Calciumhexaluminate, CA6). The bio-acces¬sible parts were measured.

Test guideline

Qualifier:

according to guideline

Guideline:

other: Bioaccessibility testing of Cobalt compounds, Woodhall Stopford et al., J. Environ. Monit. 5, 2003, p. 675-680

Deviations:

yes

Remarks:

Shaking was not performed, no addition of KCl was necessary.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Dodecaaluminium calcium nonadecaoxide

EC Number:

234-468-4

EC Name:

Dodecaaluminium calcium nonadecaoxide

Cas Number:

12005-50-4

Molecular formula:

Al12O19.Ca

IUPAC Name:

dodecaaluminium(3+) calcium nonadecaoxidandiide

Results and discussion

Any other information on results incl. tables

Calculation of Mobilised Mass

The mobilised masses of the elements were calculated asThe mobilised masses of the two elements were calculated from

 

w_i,mob  = (C_i  * V )/m_E 

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 (0.05 L in all samples)

m_E             = weight of used test item (nominal: 1.0 g, real weights were used for calc.)

 

Calculation of Bioaccessibility

Bioaccessibility was calculated as

 

R_i   =  (w_i,mob  * 100%)/ w_i,total     

with

R_i               = bioaccessible part in %

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

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

 

The mobilised masses of the measured element Al and the bioaccessibilities after 72 hours are presented in the following table:

Bioaccessible Part Al, summary

Parameter	Mean (72 h)	Standard Deviation	Relative Standard Deviation (%)
Mobilised mass of test item in µg/g	52.43	0.60	1.1%
Bioaccessibility in %	1.08 * 10^-04	1.23 * 10^-06	1.1%

Because of the presence of Ca in synthetical lung fluid, the bioaccessibility was determined from Al-content only.

Applicant's summary and conclusion

Conclusions:

The test item was incubated in synthetical lung fluid (Modified Gambles solution) for a period of three days. Incubation temperature was 37 °C, atmosphere contained 5% CO2.

Samples were taken after 2, 5, 24 and 72 hours incubation time. At each sampling, two flasks were opened and filtrated through 0.45-µm membrane filters. Concentration of the test item was measured using flame AAS after addition of 1% (V/V) conc. HCl. The blanks were analysed at the last sampling point only.
Because of the presence of Ca in synthetical lung fluid, the bioaccessibility was determined from Al-content only.
The mobilised masses of the test item and the bioaccessibility are presented in the following table:

Parameter Mean (72 h) Standard Deviation Relative Standard Deviation (%)
Mobilised mass of test item 52.43 µg/g 0.60 µg/g 1.1%
Bioaccessibility in % 1.08 * 10-04 % 1.23 * 10-06 % 1.1%

Executive summary:

The test item was incubated in synthetical lung fluid (Modified Gambles solution) for a period of three days. Incubation temperature was 37 °C, atmosphere contained 5% CO₂.

 

Samples were taken after 2, 5, 24 and 72 hours incubation time. At each sampling, two flasks were opened and filtrated through 0.45-µm membrane filters. Concentration of the test item was measured using flame AAS after addition of 1% (V/V) conc. HCl. The blanks were analysed at the last sampling point only.

Because of the presence of Ca in synthetical lung fluid, the bioaccessibility was determined from Al-content only.

The mobilised masses of the test item and the bioaccessibility are presented in the following table:

 

Parameter	Mean (72 h)	Standard Deviation	Relative Standard Deviation (%)
Mobilised mass of test item	52.43 µg/g	0.60 µg/g	1.1%
Bioaccessibility in %	1.08 * 10^-04%	1.23 * 10^-06%	1.1%