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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:
2010-02-10 - 2010-02-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-study

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 HET-CAM Method Protocol, Nov. 2006
Deviations:
yes
Remarks:
Humidity during the nine day incubation of the eggs was not 58 ± 2%, but 58 ± 3%. As the eggs showed to be viable, this deviation was considered as uncritical.
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Mullite
EC Number:
215-113-2
EC Name:
Mullite
Cas Number:
1302-93-8
Molecular formula:
Al6O13Si2
IUPAC Name:
Mullite

Test animals / tissue source

Species:
other: Lohmann selected Leghorn chicken's eggs
Strain:
other: not applicable

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
253.5 mg (mean)
Duration of treatment / exposure:
301 seconds
Observation period (in vivo):
5 minutes
Number of animals or in vitro replicates:
6 eggs

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 301 seconds
Score:
0
Max. score:
21
Reversibility:
not specified

Any other information on results incl. tables

 Observations

The observations which were made are given in the following table:

        Experimental Observations

Test Group

Amount applied

Time until Haemorrhage

Time until Lysis

Time until Coagulation

 

 

seconds      

seconds

seconds

Negative Control

300 µL

301

301

301

300 µL

301

301

301

300 µL

301

301

301

Positive Control 0.1-N NaOH

300 µL

8

21

14

300 µL

9

22

16

300 µL

8

22

15

Positive Control 1% SDS

300 µL

14

28

301

300 µL

15

29

301

300 µL

14

28

301

White Fused Mullite

294.3 mg

301

301

301

242.1 mg

301

301

301

235.5 mg

301

301

301

265.0 mg

301

301

301

275.8 mg

301

301

301

208.4 mg

301

301

301

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

0.00

0.00

Positive Control 0.1-N NaOH       

20.03

19.98

19.93

19.97

Positive Control 1% SDS

11.15

11.14

11.11

11.15

White Fused Mullite

0.00

0.00

0.00

0.00

0.00

0.00

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 itemWhite Fused Mulliteshowed 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 White Fused Mullite 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 sulphate (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 ofWhite Fused Mulliteby 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 sulphate (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.

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