dialuminium manganese tetraoxide, spinel type

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 - 2009-06-26

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline 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: ICCVAM Test Method Evaluation Report: Appendix G: ICCVAM recommended HET-CAM Method Protocol (Nov. 2006)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Ceramic materials and wares, chemicals

EC Number:

266-340-9

EC Name:

Ceramic materials and wares, chemicals

Cas Number:

66402-68-4

Molecular formula:

MnAl2O4

IUPAC Name:

dialuminium manganese 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 as positive, 3 eggs as negative control

Amount / concentration applied:

0.3015 g (mean)

Duration of treatment / exposure:

301 seconds

Observation period (in vivo):

301 seconds

Number of animals or in vitro replicates:

6 eggs

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Run / experiment:

1

Value:

0

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

Findings and Results

 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	19.41	19.43
Positive Control 0.1-N NaOH	19.38
Positive Control 0.1-N NaOH	19.52
Positive Control 1% SDS	10.57	10.58
Positive Control 1% SDS	10.63
Positive Control 1% SDS	10.53
Galaxite	0.00	0.00
Galaxite	0.00
Galaxite	0.00
Galaxite	0.00
Galaxite	0.00
Galaxite	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

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 Galaxite 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 negative control showed no irritation, the irritation score for the positive controls lay within the demanded range.
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 ofGalaxiteby 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 negative control showed no irritation, the irritation score for the positive controls lay within the demanded range.

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.