Aluminum iron oxide (Al2FeO4)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009-07-14 - 2009-09-24

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

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD , Draft Proposal for a New Guideline, In Vitro Skin Irritation: Human Skin Model Test, December 2007

Deviations:

yes

Remarks:

In the first pre-test for colour formation, 1 mL H2O demin. was used instead of 0.3 mL H2O demin. This deviation was assessed as uncritical; no formation of colour was observed after the incubation time.

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

Test animals

Species:

other: Not applicable

Strain:

other: Not applicable

Test system

Type of coverage:

open

Preparation of test site:

other: Not applicable

Vehicle:

unchanged (no vehicle)

Controls:

other: 3 tissues for negative control, 3 tissues for positive control

Amount / concentration applied:

Tissue Amount
1 24.5 mg
2 25.0 mg
3 24.7 mg

Duration of treatment / exposure:

60 min.

Observation period:

total incubation time: 42 hours

Number of animals:

3 tissues

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

other: other: % Formazan Production

Value:

90.9

Remarks on result:

other:

Remarks:

Basis: mean. Time point: 42 hours. Max. score: 0.0. Reversibility: no data. (migrated information)

Any other information on results incl. tables

Absorption values negative control, test item and positive control (OD at 570 nm)    

Designation	Negative Control			Positive Control			Hercynite
Replicate	1	2	3	1	2	3	1	2	3
Absorption 1	2.355	1.855	1.926	0.199	0.208	0.223	1.922	1.850	1.821
Absorption 2	2.344	1.818	1.928	0.201	0.206	0.189	1.902	1.809	1.832
Following calculation of the mean, the mean absorption value of isopropanol was subtracted.
Absorption Mean - Blank	2.307	1.794	1.884	0.157	0.164	0.163	1.869	1.787	1.784
Absorption Total Mean	1.995			0.161			1.813
Absorption RSD	13.7 %			2.4%			2.7%

For the test item and the positive control, the following percentage values of mean formazan production were calculated in comparison to the negative control:

  % Formazan Production

Test Item	Positive Control
90.9%	8.1%

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item is considered not irritant.
After the treatment, the relative absorbance values were decreased to 90.9%. This value is well above the threshold for irritation (50%).
The optical density of the negative control was well within the required acceptability criterion of 1.0 < mean OD < 2.5. The positive control induced a decrease in the relative absorbance as compared to the negative control to 8.1 % (required:  20%) thus ensuring the validity of the test system. Variation within replicates was within the accepted range for negative control, positive control and test item.
For these reasons, the result of the test is considered valid.

Executive summary:

The test item is considered not irritant.

After the treatment, the relative absorbance values were decreased to 90.9%. This value is well above the threshold for irritation (50%).

The optical density of the negative control was well within the required acceptability criterion of 1.0 < mean OD < 2.5. The positive control induced a decrease in the relative absorbance as compared to the negative control to 8.1 % (required:£20%) thus ensuring the validity of the test system. Variation within replicates was within the accepted range for negative control, positive control and test item.

For these reasons, the result of the test is considered valid.