Aluminum iron oxide (Al2FeO4)

Additional toxicological data

Administrative data

Endpoint:

additional toxicological information

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009-07-30 - 2009-10-27

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:

Determination of the resorption in the lung of Hercynite in order to determine the bio-accessible parts.

Test guideline

Test guideline 1

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:

Temperature was 37 ± 1.5 °C instead of 37 ± 1 °C. As virtually no dissolution of the test item was observed, the deviation was assessed as uncritical.

Test guideline 2

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 performed for two hours only in order to prevent too high temperatures in the incubator. As no dissolution was observed in the first flasks, this is considered as uncritical concerning the outcome of the study.

Test guideline 3

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:

Because of presence of KCl in synth. lung fluid, no addition of KCl before measurement via AAS was necessary.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

dialuminium iron tetraoxide, spinel type

EC Number:

924-056-9

Cas Number:

1302-61-0

Molecular formula:

Al2FeO4

IUPAC Name:

dialuminium iron tetraoxide, spinel type

Results and discussion

Any other information on results incl. tables

1.1       Calculation of Mobilised Mass

The 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.)

 

1.2       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

 

1.3 Bioaccessible Parts (Al-Content)

The bioaccessible part R_iat each sampling date as calculated from the measured Al concentrations in the solutions, the weights used and the Al content of the test item is presented in the following table:

  Bioaccessible Part Al

Flask	Weight	Sampling Time	Measured value for Al	Measured value for Al	wi,mob	Ri
	g	h	mg/L	µg/L	µg/g	%
1*	1.0700	2	< LOQ	< LOQ	< LOQ	<4.523 * 10^-5
2*	1.0405	2	< LOQ	< LOQ	< LOQ	<4.652 * 10^-5
3	1.0762	5	0.253	0.256	11.9	4.599* 10^-5
4*	1.0418	5	< LOQ	< LOQ	< LOQ	<4.646 * 10^-5
5	1.0653	24	0.442	442	20.74	8.031 * 10^-5
6	1.0947	24	0.390	390	17.82	6.902 * 10^-5
7	1.0057	72	0.569	569	28.30	1.096 * 10^-4
8	1.0105	72	0.473	473	23.42	9.070 * 10^-5

R_iwas determined from LOQ of Al (0.25 mg/l)

The mobilised masses of the measured elements and the bioaccessibilities summary after 72 h are presented in the following table:

  Bioaccessible Part Al, summary

Parameter	Mean	Standard Deviation	Relative Standard Deviation (%)
Mobilised mass of test item in µg/g	25.86	3.45	13%
Bioaccessibility in %	1.00 * 10^-4	1.33 * 10^-5	13%

1.1       Bioaccessible Parts (Fe-Content)

The bioaccessible part R_i at each sampling date as calculated from the measuredFeconcentrations in the solutions, the weights used and the Fe content of the test item is presented in the following table:

  Bioaccessible PartFe

Flask	Weight	Sampling Time	Measured value for Fe	Measured value for Fe	wi,mob	Ri*
	g	h	mg/L	µg/L	µg/g	%
1	1.0700	2	< LOQ	< LOQ	< LOQ	<1.336 * 10^-6
2	1.0405	2	< LOQ	< LOQ	< LOQ	<1.374 * 10^-6
3	1.0762	5	< LOQ	< LOQ	< LOQ	<1.328 * 10^-6
4	1.0418	5	< LOQ	< LOQ	< LOQ	<1.372 * 10^-6
5	1.0653	24	< LOQ	< LOQ	< LOQ	<1.342 * 10^-6
6	1.0947	24	< LOQ	< LOQ	< LOQ	<1.306 * 10^-6
7	1.0057	72	< LOQ	< LOQ	< LOQ	<1.422 * 10^-6
8	1.0105	72	< LOQ	< LOQ	< LOQ	<1.415 * 10^-6

* R_iwas determined from LOQ of Fe (0.0094 mg/l)

Applicant's summary and conclusion

Conclusions:

The bioaccessibility of the test item in the lung is 1.00 *10-4% (Al-content) and less then 1.422 * 10-6% (Fe-content).

Executive summary:

All replicates shows good correspondance. Poor dissolution of the test item was observed. The bioaccessibility of the test item in the lung is 1.00 *10^-4% (Al-content) and less then 1.422 * 10^-6% (Fe-content).

The deviation between Fe and Al shows, that the test item is perhaps not a well defined compound but rather a mixed crystal, where some parts are more soluble as others.

The mobilised masses of the measured elements and the bio-accessibilities after 72 hours incubation are presented in the following table:

Parameter	Mean	Standard Deviation	Relative Standard Deviation (%)
Mobilised mass of test item (Al) in µg/g	25.86	3.45	13%
Bioaccessibility (Al) in %	1.00 * 10^-04	1.34* 10^-05	13%

The values of Fe were below LOQ, therefore R_ifor Fe is less then 1.422 * 10^-6% (value determined from LOQ 0.0094 mg/L).