Spinel (Mg(AlO2)2)

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 - 2009-06-22

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: ICCVAm Test Method Evaluation Report: Appendix G, ICCVAM recommended HET-CAM Method protocol (Nov. 2006)

Deviations:

yes

Remarks:

Eggs were not candled on the eighth day, but on the day of beginning of the study .

Principles of method if other than guideline:

ICCVAm test Method Evaluation Report: Appendix G - ICCVAM recommended HET-CAM method Protocol (Nov.2006)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Spinel (Mg(AlO2)2)

EC Number:

215-105-9

EC Name:

Spinel (Mg(AlO2)2)

Cas Number:

1302-67-6

Molecular formula:

AlO2.1/2Mg

IUPAC Name:

magnesium dialuminium oxide

Details on test material:

Purity > 99%
Batch no. SP-AR78 -20MY, batch: 082519351
Expiry date: unlimited

Test animals / tissue source

Species:

other: chicken's eggs

Strain:

other: Leghorn's chicken's eggs

Details on test animals or tissues and environmental conditions:

Species: Lohmann selected Leghorn chicken's eggs

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: Negative control: physiol. sodium chloride solution

Duration of treatment / exposure:

300 seconds

Observation period (in vivo):

300 seconds

Number of animals or in vitro replicates:

6 chicken eggs

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Value:

0

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

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

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Both positive controls (sodium dodecyl sulfate 1 %) induced 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.

Executive summary:

This in vitro study was performed to assess the irritating potential of Spinel 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.

Both positive controls induced 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.