Aluminum iron oxide (Al2FeO4)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009-05-05 - 2009-06-05

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 405 Draft Guideline "Acute Eye Irritation/Corrosion", adopted 24. April 2002

Deviations:

no

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 / tissue source

Species:

other: Lohmann selected leghorn chicken's eggs

Strain:

other: not applicable

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: 6 eggs for positive control, 3 eggs for negative control

Amount / concentration applied:

300 mg

Duration of treatment / exposure:

301 seconds

Observation period (in vivo):

301 seconds

Number of animals or in vitro replicates:

6 chicken eggs

Results and discussion

In vivo

Results

Irritation parameter:

other: Mean Irritation Score

Basis:

mean

Time point:

other: 301 seconds

Score:

0

Max. score:

21

Reversibility:

not specified

Any other information on results incl. tables

The calculated IS for each replicate and the corresponding means are presented in the following table:

  Irritation Score

Test Group	Irritation Score	Mean Irritation Score
Negative Control	0.00	0.00
Negative Control	0.00
Negative Control	0.00
Positive Control 0.1-N NaOH	19.54	19.56
Positive Control 0.1-N NaOH	19.60
Positive Control 0.1-N NaOH	19.54
Positive Control 1% SDS	10.55	10.48
Positive Control 1% SDS	10.49
Positive Control 1% SDS	10.41
Hercynite	0.00	0.00
Hercynite	0.00
Hercynite	0.00
Hercynite	0.00
Hercynite	0.00
Hercynite	0.00

Classification

Classification of the irritation potential is made as stated in the following table:

 Classification

Irritation Score (IS)	Classification
0 - 0.9	not irritant
1 - 4.9	slightly irritant
5 - 8.9	moderately irritant
9 - 21	severely irritant

In the negative control, no signs of irritation were observed. Both positive controls showed severe irritation. The test itemHercyniteshowed no irritation.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

This in vitro study was performed to assess the irritating potential of Hercynite by detection of damages in blood vessels under the chorionallantoic membrane of incubated chicken eggs (nine days old). Observation time was 5 minutes at room temperature.
Physiological sodium chloride solution was used as negative control, sodium dodecyl sulfate (1% solution ) and sodium hydroxide (0.1-n solution) were used as positive controls.
The positive controls induced a severe irritation on the blood vessels, the irritation score for the positive controls lay within the demanded range. The negative control showed no irritation.
The test item was tested pure. A mean irritation score of 0.0 was calculated, corresponding to a classification as not irritant.
No observations were made which might cause doubts concerning the validity of the study outcome. The test is considered valid.

Executive summary:

This in vitro study was performed to assess the irritating potential of Hercyniteby detection of damages in blood vessels under the chorionallantoic membrane of incubated chicken eggs (nine days old). Observation time was 5 minutes at room temperature.

Physiological sodium chloride solution was used as negative control, sodium dodecyl sulfate (1% solution ) and sodium hydroxide (0.1-n solution) were used as positive controls.

The positive controls induced a severe irritation on the blood vessels, the irritation score for the positive controls lay within the demanded range. The negative control showed no irritation.

The test item was tested pure. A mean irritation score of 0.0 was calculated, corresponding to a classification as not irritant.

No observations were made which might cause doubts concerning the validity of the study outcome. The test is considered valid.