Mullite

Eye irritation

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

Test material information

Constituent 1

Reference substance name:

Mullite

EC Number:

215-113-2

EC Name:

Mullite

Cas Number:

1302-93-8

Molecular formula:

Al6O13Si2

IUPAC Name:

Mullite; Al6O13Si2

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.