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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
February 2010
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: ICCVAM Test Method Evaluation Report: Appendix G: ICCVAM Recommended Protocol for Future Studies Using the Hen’s Egg Test-Chorionallantoic Membrane (HET-CAM) Test method, November 2006.
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of aluminium and magnesium oxide and spinel (Mg(AlO2)2)
EC Number:
701-289-2
Molecular formula:
Al, MgO, Mg(AlO2)2
IUPAC Name:
Reaction mass of aluminium and magnesium oxide and spinel (Mg(AlO2)2)
Details on test material:
- Name of test material (as cited in study report): Aluminium-Skimmings
- Physical state: grey solid
- Analytical purity: Aluminium: 708.0 g/kg
Ammonium(NH4): 22.0 g/kg
Magnesium: 68.0 g/kg
- Lot/batch No.: Lieferung vom 21.04.2009
- Stability under test conditions: until August 21, 2011
- Storage condition of test material: room temperature

Test animals / tissue source

Details on test animals or tissues and environmental conditions:
The fertile Lohmann Brown extra hen eggs (Brinkschulte Josef GmbH & Co.KG, 48308 Senden) were incubated in an incubator with an automatic rotating device (e.g. Ehret GmbH), optimum temperature : 37.5 °C, relative humidity 63%.

After 7 days of incubation, all eggs were candled in order to discard those that were defect and to mark the air bubble. The eggs were replaced into the incubator with the large end upward but not rotated, thus ensuring accessibility to the CAM region.

At day 8 of incubation the sections marked for the air bubble were sawed out of the shell. The inner membrane was moistened with NaCl 0.9 % and carefully removed with forceps. Only eggs with normally developed embryos and blood vessel systems were used for testing.

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
300 mg per egg
Duration of treatment / exposure:
300 seconds
Observation period (in vivo):
300 seconds
Number of animals or in vitro replicates:
4 eggs were used

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 300 sec
Score:
0
Max. score:
21
Remarks on result:
other: test substance
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 300 sec
Score:
0
Max. score:
21
Remarks on result:
other: negative control (saline)
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 300 sec
Score:
10
Max. score:
21
Remarks on result:
other: positive control (1% SDS)

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Aluminium skimmings have no eye irritation potential based on the results of this HETCAM test.

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